This is page 17 of 19. Use http://codebase.md/genomoncology/biomcp?lines=true&page={x} to view the full context.
# Directory Structure
```
├── .github
│ ├── actions
│ │ └── setup-python-env
│ │ └── action.yml
│ ├── dependabot.yml
│ └── workflows
│ ├── ci.yml
│ ├── deploy-docs.yml
│ ├── main.yml.disabled
│ ├── on-release-main.yml
│ └── validate-codecov-config.yml
├── .gitignore
├── .pre-commit-config.yaml
├── BIOMCP_DATA_FLOW.md
├── CHANGELOG.md
├── CNAME
├── codecov.yaml
├── docker-compose.yml
├── Dockerfile
├── docs
│ ├── apis
│ │ ├── error-codes.md
│ │ ├── overview.md
│ │ └── python-sdk.md
│ ├── assets
│ │ ├── biomcp-cursor-locations.png
│ │ ├── favicon.ico
│ │ ├── icon.png
│ │ ├── logo.png
│ │ ├── mcp_architecture.txt
│ │ └── remote-connection
│ │ ├── 00_connectors.png
│ │ ├── 01_add_custom_connector.png
│ │ ├── 02_connector_enabled.png
│ │ ├── 03_connect_to_biomcp.png
│ │ ├── 04_select_google_oauth.png
│ │ └── 05_success_connect.png
│ ├── backend-services-reference
│ │ ├── 01-overview.md
│ │ ├── 02-biothings-suite.md
│ │ ├── 03-cbioportal.md
│ │ ├── 04-clinicaltrials-gov.md
│ │ ├── 05-nci-cts-api.md
│ │ ├── 06-pubtator3.md
│ │ └── 07-alphagenome.md
│ ├── blog
│ │ ├── ai-assisted-clinical-trial-search-analysis.md
│ │ ├── images
│ │ │ ├── deep-researcher-video.png
│ │ │ ├── researcher-announce.png
│ │ │ ├── researcher-drop-down.png
│ │ │ ├── researcher-prompt.png
│ │ │ ├── trial-search-assistant.png
│ │ │ └── what_is_biomcp_thumbnail.png
│ │ └── researcher-persona-resource.md
│ ├── changelog.md
│ ├── CNAME
│ ├── concepts
│ │ ├── 01-what-is-biomcp.md
│ │ ├── 02-the-deep-researcher-persona.md
│ │ └── 03-sequential-thinking-with-the-think-tool.md
│ ├── developer-guides
│ │ ├── 01-server-deployment.md
│ │ ├── 02-contributing-and-testing.md
│ │ ├── 03-third-party-endpoints.md
│ │ ├── 04-transport-protocol.md
│ │ ├── 05-error-handling.md
│ │ ├── 06-http-client-and-caching.md
│ │ ├── 07-performance-optimizations.md
│ │ └── generate_endpoints.py
│ ├── faq-condensed.md
│ ├── FDA_SECURITY.md
│ ├── genomoncology.md
│ ├── getting-started
│ │ ├── 01-quickstart-cli.md
│ │ ├── 02-claude-desktop-integration.md
│ │ └── 03-authentication-and-api-keys.md
│ ├── how-to-guides
│ │ ├── 01-find-articles-and-cbioportal-data.md
│ │ ├── 02-find-trials-with-nci-and-biothings.md
│ │ ├── 03-get-comprehensive-variant-annotations.md
│ │ ├── 04-predict-variant-effects-with-alphagenome.md
│ │ ├── 05-logging-and-monitoring-with-bigquery.md
│ │ └── 06-search-nci-organizations-and-interventions.md
│ ├── index.md
│ ├── policies.md
│ ├── reference
│ │ ├── architecture-diagrams.md
│ │ ├── quick-architecture.md
│ │ ├── quick-reference.md
│ │ └── visual-architecture.md
│ ├── robots.txt
│ ├── stylesheets
│ │ ├── announcement.css
│ │ └── extra.css
│ ├── troubleshooting.md
│ ├── tutorials
│ │ ├── biothings-prompts.md
│ │ ├── claude-code-biomcp-alphagenome.md
│ │ ├── nci-prompts.md
│ │ ├── openfda-integration.md
│ │ ├── openfda-prompts.md
│ │ ├── pydantic-ai-integration.md
│ │ └── remote-connection.md
│ ├── user-guides
│ │ ├── 01-command-line-interface.md
│ │ ├── 02-mcp-tools-reference.md
│ │ └── 03-integrating-with-ides-and-clients.md
│ └── workflows
│ └── all-workflows.md
├── example_scripts
│ ├── mcp_integration.py
│ └── python_sdk.py
├── glama.json
├── LICENSE
├── lzyank.toml
├── Makefile
├── mkdocs.yml
├── package-lock.json
├── package.json
├── pyproject.toml
├── README.md
├── scripts
│ ├── check_docs_in_mkdocs.py
│ ├── check_http_imports.py
│ └── generate_endpoints_doc.py
├── smithery.yaml
├── src
│ └── biomcp
│ ├── __init__.py
│ ├── __main__.py
│ ├── articles
│ │ ├── __init__.py
│ │ ├── autocomplete.py
│ │ ├── fetch.py
│ │ ├── preprints.py
│ │ ├── search_optimized.py
│ │ ├── search.py
│ │ └── unified.py
│ ├── biomarkers
│ │ ├── __init__.py
│ │ └── search.py
│ ├── cbioportal_helper.py
│ ├── circuit_breaker.py
│ ├── cli
│ │ ├── __init__.py
│ │ ├── articles.py
│ │ ├── biomarkers.py
│ │ ├── diseases.py
│ │ ├── health.py
│ │ ├── interventions.py
│ │ ├── main.py
│ │ ├── openfda.py
│ │ ├── organizations.py
│ │ ├── server.py
│ │ ├── trials.py
│ │ └── variants.py
│ ├── connection_pool.py
│ ├── constants.py
│ ├── core.py
│ ├── diseases
│ │ ├── __init__.py
│ │ ├── getter.py
│ │ └── search.py
│ ├── domain_handlers.py
│ ├── drugs
│ │ ├── __init__.py
│ │ └── getter.py
│ ├── exceptions.py
│ ├── genes
│ │ ├── __init__.py
│ │ └── getter.py
│ ├── http_client_simple.py
│ ├── http_client.py
│ ├── individual_tools.py
│ ├── integrations
│ │ ├── __init__.py
│ │ ├── biothings_client.py
│ │ └── cts_api.py
│ ├── interventions
│ │ ├── __init__.py
│ │ ├── getter.py
│ │ └── search.py
│ ├── logging_filter.py
│ ├── metrics_handler.py
│ ├── metrics.py
│ ├── openfda
│ │ ├── __init__.py
│ │ ├── adverse_events_helpers.py
│ │ ├── adverse_events.py
│ │ ├── cache.py
│ │ ├── constants.py
│ │ ├── device_events_helpers.py
│ │ ├── device_events.py
│ │ ├── drug_approvals.py
│ │ ├── drug_labels_helpers.py
│ │ ├── drug_labels.py
│ │ ├── drug_recalls_helpers.py
│ │ ├── drug_recalls.py
│ │ ├── drug_shortages_detail_helpers.py
│ │ ├── drug_shortages_helpers.py
│ │ ├── drug_shortages.py
│ │ ├── exceptions.py
│ │ ├── input_validation.py
│ │ ├── rate_limiter.py
│ │ ├── utils.py
│ │ └── validation.py
│ ├── organizations
│ │ ├── __init__.py
│ │ ├── getter.py
│ │ └── search.py
│ ├── parameter_parser.py
│ ├── prefetch.py
│ ├── query_parser.py
│ ├── query_router.py
│ ├── rate_limiter.py
│ ├── render.py
│ ├── request_batcher.py
│ ├── resources
│ │ ├── __init__.py
│ │ ├── getter.py
│ │ ├── instructions.md
│ │ └── researcher.md
│ ├── retry.py
│ ├── router_handlers.py
│ ├── router.py
│ ├── shared_context.py
│ ├── thinking
│ │ ├── __init__.py
│ │ ├── sequential.py
│ │ └── session.py
│ ├── thinking_tool.py
│ ├── thinking_tracker.py
│ ├── trials
│ │ ├── __init__.py
│ │ ├── getter.py
│ │ ├── nci_getter.py
│ │ ├── nci_search.py
│ │ └── search.py
│ ├── utils
│ │ ├── __init__.py
│ │ ├── cancer_types_api.py
│ │ ├── cbio_http_adapter.py
│ │ ├── endpoint_registry.py
│ │ ├── gene_validator.py
│ │ ├── metrics.py
│ │ ├── mutation_filter.py
│ │ ├── query_utils.py
│ │ ├── rate_limiter.py
│ │ └── request_cache.py
│ ├── variants
│ │ ├── __init__.py
│ │ ├── alphagenome.py
│ │ ├── cancer_types.py
│ │ ├── cbio_external_client.py
│ │ ├── cbioportal_mutations.py
│ │ ├── cbioportal_search_helpers.py
│ │ ├── cbioportal_search.py
│ │ ├── constants.py
│ │ ├── external.py
│ │ ├── filters.py
│ │ ├── getter.py
│ │ ├── links.py
│ │ └── search.py
│ └── workers
│ ├── __init__.py
│ ├── worker_entry_stytch.js
│ ├── worker_entry.js
│ └── worker.py
├── tests
│ ├── bdd
│ │ ├── cli_help
│ │ │ ├── help.feature
│ │ │ └── test_help.py
│ │ ├── conftest.py
│ │ ├── features
│ │ │ └── alphagenome_integration.feature
│ │ ├── fetch_articles
│ │ │ ├── fetch.feature
│ │ │ └── test_fetch.py
│ │ ├── get_trials
│ │ │ ├── get.feature
│ │ │ └── test_get.py
│ │ ├── get_variants
│ │ │ ├── get.feature
│ │ │ └── test_get.py
│ │ ├── search_articles
│ │ │ ├── autocomplete.feature
│ │ │ ├── search.feature
│ │ │ ├── test_autocomplete.py
│ │ │ └── test_search.py
│ │ ├── search_trials
│ │ │ ├── search.feature
│ │ │ └── test_search.py
│ │ ├── search_variants
│ │ │ ├── search.feature
│ │ │ └── test_search.py
│ │ └── steps
│ │ └── test_alphagenome_steps.py
│ ├── config
│ │ └── test_smithery_config.py
│ ├── conftest.py
│ ├── data
│ │ ├── ct_gov
│ │ │ ├── clinical_trials_api_v2.yaml
│ │ │ ├── trials_NCT04280705.json
│ │ │ └── trials_NCT04280705.txt
│ │ ├── myvariant
│ │ │ ├── myvariant_api.yaml
│ │ │ ├── myvariant_field_descriptions.csv
│ │ │ ├── variants_full_braf_v600e.json
│ │ │ ├── variants_full_braf_v600e.txt
│ │ │ └── variants_part_braf_v600_multiple.json
│ │ ├── openfda
│ │ │ ├── drugsfda_detail.json
│ │ │ ├── drugsfda_search.json
│ │ │ ├── enforcement_detail.json
│ │ │ └── enforcement_search.json
│ │ └── pubtator
│ │ ├── pubtator_autocomplete.json
│ │ └── pubtator3_paper.txt
│ ├── integration
│ │ ├── test_openfda_integration.py
│ │ ├── test_preprints_integration.py
│ │ ├── test_simple.py
│ │ └── test_variants_integration.py
│ ├── tdd
│ │ ├── articles
│ │ │ ├── test_autocomplete.py
│ │ │ ├── test_cbioportal_integration.py
│ │ │ ├── test_fetch.py
│ │ │ ├── test_preprints.py
│ │ │ ├── test_search.py
│ │ │ └── test_unified.py
│ │ ├── conftest.py
│ │ ├── drugs
│ │ │ ├── __init__.py
│ │ │ └── test_drug_getter.py
│ │ ├── openfda
│ │ │ ├── __init__.py
│ │ │ ├── test_adverse_events.py
│ │ │ ├── test_device_events.py
│ │ │ ├── test_drug_approvals.py
│ │ │ ├── test_drug_labels.py
│ │ │ ├── test_drug_recalls.py
│ │ │ ├── test_drug_shortages.py
│ │ │ └── test_security.py
│ │ ├── test_biothings_integration_real.py
│ │ ├── test_biothings_integration.py
│ │ ├── test_circuit_breaker.py
│ │ ├── test_concurrent_requests.py
│ │ ├── test_connection_pool.py
│ │ ├── test_domain_handlers.py
│ │ ├── test_drug_approvals.py
│ │ ├── test_drug_recalls.py
│ │ ├── test_drug_shortages.py
│ │ ├── test_endpoint_documentation.py
│ │ ├── test_error_scenarios.py
│ │ ├── test_europe_pmc_fetch.py
│ │ ├── test_mcp_integration.py
│ │ ├── test_mcp_tools.py
│ │ ├── test_metrics.py
│ │ ├── test_nci_integration.py
│ │ ├── test_nci_mcp_tools.py
│ │ ├── test_network_policies.py
│ │ ├── test_offline_mode.py
│ │ ├── test_openfda_unified.py
│ │ ├── test_pten_r173_search.py
│ │ ├── test_render.py
│ │ ├── test_request_batcher.py.disabled
│ │ ├── test_retry.py
│ │ ├── test_router.py
│ │ ├── test_shared_context.py.disabled
│ │ ├── test_unified_biothings.py
│ │ ├── thinking
│ │ │ ├── __init__.py
│ │ │ └── test_sequential.py
│ │ ├── trials
│ │ │ ├── test_backward_compatibility.py
│ │ │ ├── test_getter.py
│ │ │ └── test_search.py
│ │ ├── utils
│ │ │ ├── test_gene_validator.py
│ │ │ ├── test_mutation_filter.py
│ │ │ ├── test_rate_limiter.py
│ │ │ └── test_request_cache.py
│ │ ├── variants
│ │ │ ├── constants.py
│ │ │ ├── test_alphagenome_api_key.py
│ │ │ ├── test_alphagenome_comprehensive.py
│ │ │ ├── test_alphagenome.py
│ │ │ ├── test_cbioportal_mutations.py
│ │ │ ├── test_cbioportal_search.py
│ │ │ ├── test_external_integration.py
│ │ │ ├── test_external.py
│ │ │ ├── test_extract_gene_aa_change.py
│ │ │ ├── test_filters.py
│ │ │ ├── test_getter.py
│ │ │ ├── test_links.py
│ │ │ └── test_search.py
│ │ └── workers
│ │ └── test_worker_sanitization.js
│ └── test_pydantic_ai_integration.py
├── THIRD_PARTY_ENDPOINTS.md
├── tox.ini
├── uv.lock
└── wrangler.toml
```
# Files
--------------------------------------------------------------------------------
/tests/data/ct_gov/trials_NCT04280705.txt:
--------------------------------------------------------------------------------
```
1 | Next Page Token: NF0g5JCEk_IgxQc
2 |
3 | # Studies
4 | Has Results: True
5 |
6 | ## Protocol Section
7 |
8 | ### Identification Module
9 | Nct Id: NCT04280705
10 | Brief Title: Adaptive COVID-19 Treatment Trial (ACTT)
11 | Official Title:
12 | A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the
13 | Safety and Efficacy of Investigational Therapeutics for the Treatment of
14 | COVID-19 in Hospitalized Adults
15 |
16 | #### Org Study Id Info
17 | Id: 20-0006
18 |
19 | #### Organization
20 | Full Name: National Institute of Allergy and Infectious Diseases (NIAID)
21 | Class: NIH
22 |
23 | ### Status Module
24 | Status Verified Date: 2020-04
25 | Overall Status: COMPLETED
26 | Study First Submit Date: 2020-02-20
27 | Study First Submit Qc Date: 2020-02-20
28 | Results First Submit Date: 2020-09-16
29 | Results First Submit Qc Date: 2020-09-22
30 | Last Update Submit Date: 2022-03-09
31 |
32 | #### Expanded Access Info
33 | Has Expanded Access: False
34 |
35 | #### Start Date Struct
36 | Date: 2020-02-21
37 | Type: ACTUAL
38 |
39 | #### Primary Completion Date Struct
40 | Date: 2020-05-21
41 | Type: ACTUAL
42 |
43 | #### Completion Date Struct
44 | Date: 2020-05-21
45 | Type: ACTUAL
46 |
47 | #### Study First Post Date Struct
48 | Date: 2020-02-21
49 | Type: ACTUAL
50 |
51 | #### Results First Post Date Struct
52 | Date: 2020-09-25
53 | Type: ACTUAL
54 |
55 | #### Last Update Post Date Struct
56 | Date: 2022-03-14
57 | Type: ACTUAL
58 |
59 | ### Sponsor Collaborators Module
60 |
61 | #### Responsible Party
62 | Type: SPONSOR
63 |
64 | #### Lead Sponsor
65 | Name: National Institute of Allergy and Infectious Diseases (NIAID)
66 | Class: NIH
67 |
68 | ### Oversight Module
69 | Is Fda Regulated Drug: True
70 | Is Fda Regulated Device: False
71 | Is Us Export: False
72 |
73 | ### Description Module
74 | Brief Summary:
75 | This study is an adaptive, randomized, double-blind, placebo-controlled
76 | trial to evaluate the safety and efficacy of novel therapeutic agents in
77 | hospitalized adults diagnosed with COVID-19. The study is a multicenter
78 | trial that will be conducted in up to approximately 100 sites globally.
79 | The study will compare different investigational therapeutic agents to a
80 | control arm. There will be interim monitoring to introduce new arms and
81 | allow early stopping for futility, efficacy, or safety. If one therapy
82 | proves to be efficacious, then this treatment may become the control arm
83 | for comparison(s) with new experimental treatment(s). Any such change
84 | would be accompanied by an updated sample size. Because background
85 | standards of supportive care may evolve/improve over time as more is
86 | learned about successful management of COVID-19, comparisons of safety
87 | and efficacy will be based on data from concurrently randomized
88 | subjects. An independent Data and Safety Monitoring Board (DSMB) will
89 | actively monitor interim data to make recommendations about early study
90 | closure or changes to study arms. To evaluate the clinical efficacy, as
91 | assessed by time to recovery, of different investigational therapeutics
92 | as compared to the control arm.
93 | Detailed Description:
94 | This study is an adaptive, randomized, double-blind, placebo-controlled
95 | trial to evaluate the safety and efficacy of novel therapeutic agents in
96 | hospitalized adults diagnosed with COVID-19. The study is a multicenter
97 | trial that will be conducted in up to approximately 100 sites globally.
98 | The study will compare different investigational therapeutic agents to a
99 | control arm. There will be interim monitoring to introduce new arms and
100 | allow early stopping for futility, efficacy, or safety. If one therapy
101 | proves to be efficacious, then this treatment may become the control arm
102 | for comparison(s) with new experimental treatment(s). Any such change
103 | would be accompanied by an updated sample size. Because background
104 | standards of supportive care may evolve/improve over time as more is
105 | learned about successful management of COVID-19, comparisons of safety
106 | and efficacy will be based on data from concurrently randomized
107 | subjects. An independent Data and Safety Monitoring Board (DSMB) will
108 | actively monitor interim data to make recommendations about early study
109 | closure or changes to study arms.
110 |
111 | The initial sample size is projected to be 572 subjects to achieve 400
112 | subjects with a "recovered" status (per the primary objective). The
113 | primary analysis will be based on those subjects enrolled in order to
114 | 400 recoveries. An additional analysis of the moderate severity subgroup
115 | (those with baseline status of "Hospitalized, requiring supplemental
116 | oxygen" or "Hospitalized, not requiring supplemental oxygen - requiring
117 | ongoing medical care") is also of public health importance. Hence,
118 | enrollment will be permitted until the date of April 20, 2020 to ensure
119 | 400 recoveries and provide additional data about this important
120 | subgroup. With recent enrollment rates, the total sample size may be 600
121 | to over 800.
122 |
123 | Subjects will be assessed daily while hospitalized. If the subjects are
124 | discharged from the hospital, they will have a study visit at Days 15,
125 | 22, and 29 as an outpatient. For discharged subjects, it is preferred
126 | that the Day 15 and 29 visits are in person to obtain safety laboratory
127 | tests and OP swab and blood (serum only) samples for secondary research
128 | as well as clinical outcome data. However, infection control or other
129 | restrictions may limit the ability of the subject to return to the
130 | clinic. In this case, Day 15 and 29 visits may be conducted by phone,
131 | and only clinical data will be obtained. The Day 22 visit does not have
132 | laboratory tests or collection of samples and may also be conducted by
133 | phone.
134 |
135 | All subjects will undergo a series of efficacy, safety, and laboratory
136 | assessments. Safety laboratory tests and blood (serum and plasma)
137 | research samples and oropharyngeal (OP) swabs will be obtained on Days 1
138 | (prior to infusion) and Days 3, 5, 8, and 11 (while hospitalized). OP
139 | swabs and blood (serum only) plus safety laboratory tests will be
140 | collected on Day 15 and 29 (if the subject attends an in-person visit or
141 | are still hospitalized).
142 |
143 | The primary outcome is time to recovery by Day 29. A key secondary
144 | outcome evaluates treatment-related improvements in the 8-point ordinal
145 | scale at Day 15. As little is known about the clinical course of
146 | COVID-19, a pilot study will be used for a blinded sample size
147 | reassessment.
148 |
149 | Contacts:
150 |
151 | 20-0006 Central Contact
152 |
153 | Telephone: 1 (301) 7617948
154 |
155 | Email: [email protected]
156 |
157 | ### Conditions Module
158 | Conditions: COVID-19
159 | Keywords:
160 | - Adaptive
161 | - COVID-19
162 | - Efficacy
163 | - Multicenter
164 | - novel coronavirus
165 | - Safety
166 | - ACTT
167 |
168 | ### Design Module
169 | Study Type: INTERVENTIONAL
170 |
171 | #### Design Info
172 | Allocation: RANDOMIZED
173 | Intervention Model: PARALLEL
174 | Primary Purpose: TREATMENT
175 |
176 | ##### Masking Info
177 | Masking: DOUBLE
178 | Who Masked: PARTICIPANT, INVESTIGATOR
179 |
180 | #### Enrollment Info
181 | Count: 1062
182 | Type: ACTUAL
183 | Phases: PHASE3
184 |
185 | ### Arms Interventions Module
186 |
187 | #### Arm Groups
188 | Label: Placebo
189 | Type: PLACEBO_COMPARATOR
190 | Description:
191 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
192 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
193 | while hospitalized for up to a 10 days total course. n=286.
194 | Intervention Names: Other: Placebo
195 |
196 | #### Arm Groups
197 | Label: Remdesivir
198 | Type: EXPERIMENTAL
199 | Description:
200 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
201 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
202 | up to a 10 days total course. n=286.
203 | Intervention Names: Drug: Remdesivir
204 |
205 | #### Interventions
206 | Type: OTHER
207 | Name: Placebo
208 | Description:
209 | The supplied placebo lyophilized formulation is identical in physical
210 | appearance to the active lyophilized formulation and contains the same
211 | inactive ingredients. Alternatively, a placebo of normal saline of equal
212 | volume may be given if there are limitations on matching placebo
213 | supplies.
214 | Arm Group Labels: Placebo
215 |
216 | #### Interventions
217 | Type: DRUG
218 | Name: Remdesivir
219 | Description:
220 | Drug Remdesivir is a single diastereomer monophosphoramidate prodrug
221 | designed for the intracellular delivery of a modified adenine nucleoside
222 | analog GS-441524. In addition to the active ingredient, the lyophilized
223 | formulation of Remdesivir contains the following inactive ingredients:
224 | water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD),
225 | and hydrochloric acid and/or sodium hydroxide.
226 | Arm Group Labels: Remdesivir
227 |
228 | ### Outcomes Module
229 |
230 | #### Primary Outcomes
231 | Measure: Time to Recovery
232 | Description:
233 | Day of recovery is defined as the first day on which the subject
234 | satisfies one of the following three categories from the ordinal scale:
235 | 1) Hospitalized, not requiring supplemental oxygen - no longer requires
236 | ongoing medical care; 2) Not hospitalized, limitation on activities
237 | and/or requiring home oxygen; 3) Not hospitalized, no limitations on
238 | activities.
239 | Time Frame: Day 1 through Day 29
240 |
241 | #### Primary Outcomes
242 | Measure: Time to Recovery by Race
243 | Description:
244 | Day of recovery is defined as the first day on which the subject
245 | satisfies one of the following three categories from the ordinal scale:
246 | 1) Hospitalized, not requiring supplemental oxygen - no longer requires
247 | ongoing medical care; 2) Not hospitalized, limitation on activities
248 | and/or requiring home oxygen; 3) Not hospitalized, no limitations on
249 | activities.
250 | Time Frame: Day 1 through Day 29
251 |
252 | #### Primary Outcomes
253 | Measure: Time to Recovery by Ethnicity
254 | Description:
255 | Day of recovery is defined as the first day on which the subject
256 | satisfies one of the following three categories from the ordinal scale:
257 | 1) Hospitalized, not requiring supplemental oxygen - no longer requires
258 | ongoing medical care; 2) Not hospitalized, limitation on activities
259 | and/or requiring home oxygen; 3) Not hospitalized, no limitations on
260 | activities.
261 | Time Frame: Day 1 through Day 29
262 |
263 | #### Primary Outcomes
264 | Measure: Time to Recovery by Sex
265 | Description:
266 | Day of recovery is defined as the first day on which the subject
267 | satisfies one of the following three categories from the ordinal scale:
268 | 1) Hospitalized, not requiring supplemental oxygen - no longer requires
269 | ongoing medical care; 2) Not hospitalized, limitation on activities
270 | and/or requiring home oxygen; 3) Not hospitalized, no limitations on
271 | activities.
272 | Time Frame: Day 1 through Day 29
273 |
274 | #### Secondary Outcomes
275 | Measure: Change From Baseline in Alanine Transaminase (ALT)
276 | Description:
277 | Blood to evaluate ALT was collected at Days 1, 3, 5, 8, and 11 while
278 | participants were inpatient, and at Days 15 and 29, with the Day 1
279 | assessment serving as baseline. Participants who had been discharged had
280 | blood collected if infection control measures allowed for in-person
281 | visits after discharge.
282 | Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
283 |
284 | #### Secondary Outcomes
285 | Measure: Change From Baseline in Aspartate Transaminase (AST)
286 | Description:
287 | Blood to evaluate AST was collected at Days 1, 3, 5, 8, and 11 while
288 | participants were inpatient, and at Days 15 and 29, with the Day 1
289 | assessment serving as baseline. Participants who had been discharged had
290 | blood collected if infection control measures allowed for in-person
291 | visits after discharge.
292 | Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
293 |
294 | #### Secondary Outcomes
295 | Measure: Change From Baseline in Creatinine
296 | Description:
297 | Blood to evaluate serum creatinine was collected at Days 1, 3, 5, 8, and
298 | 11 while participants were inpatient, and at Days 15 and 29, with the
299 | Day 1 assessment serving as baseline. Participants who had been
300 | discharged had blood collected if infection control measures allowed for
301 | in-person visits after discharge.
302 | Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
303 |
304 | #### Secondary Outcomes
305 | Measure: Change From Baseline in Glucose
306 | Description:
307 | Blood to evaluate serum glucose was collected at Days 1, 3, 5, 8, and 11
308 | while participants were inpatient, and at Days 15 and 29, with the Day 1
309 | assessment serving as baseline. Participants who had been discharged had
310 | blood collected if infection control measures allowed for in-person
311 | visits after discharge.
312 | Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
313 |
314 | #### Secondary Outcomes
315 | Measure: Change From Baseline in Hemoglobin
316 | Description:
317 | Blood to evaluate hemoglobin was collected at Days 1, 3, 5, 8, and 11
318 | while participants were inpatient, and at Days 15 and 29, with the Day 1
319 | assessment serving as baseline. Participants who had been discharged had
320 | blood collected if infection control measures allowed for in-person
321 | visits after discharge.
322 | Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
323 |
324 | #### Secondary Outcomes
325 | Measure: Change From Baseline in Platelets
326 | Description:
327 | Blood to evaluate platelets was collected at Days 1, 3, 5, 8, and 11
328 | while participants were inpatient, and at Days 15 and 29, with the Day 1
329 | assessment serving as baseline. Participants who had been discharged had
330 | blood collected if infection control measures allowed for in-person
331 | visits after discharge.
332 | Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
333 |
334 | #### Secondary Outcomes
335 | Measure: Change From Baseline in Prothrombin Time (PT)
336 | Description:
337 | Blood to evaluate PT was collected at Days 1, 3, 5, 8, and 11 while
338 | participants were inpatient, and at Days 15 and 29, with the Day 1
339 | assessment serving as baseline. Participants who had been discharged had
340 | blood collected if infection control measures allowed for in-person
341 | visits after discharge.
342 | Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
343 |
344 | #### Secondary Outcomes
345 | Measure: Change From Baseline in Total Bilirubin
346 | Description:
347 | Blood to evaluate total bilirubin was collected at Days 1, 3, 5, 8, and
348 | 11 while participants were inpatient, and at Days 15 and 29, with the
349 | Day 1 assessment serving as baseline. Participants who had been
350 | discharged had blood collected if infection control measures allowed for
351 | in-person visits after discharge.
352 | Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
353 |
354 | #### Secondary Outcomes
355 | Measure: Change From Baseline in White Blood Cell Count (WBC)
356 | Description:
357 | Blood to evaluate WBC was collected at Days 1, 3, 5, 8, and 11 while
358 | participants were inpatient, and at Days 15 and 29, with the Day 1
359 | assessment serving as baseline. Participants who had been discharged had
360 | blood collected if infection control measures allowed for in-person
361 | visits after discharge.
362 | Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
363 |
364 | #### Secondary Outcomes
365 | Measure: Change From Baseline in Neutrophils
366 | Description:
367 | Blood to evaluate neutrophils was collected at Days 1, 3, 5, 8, and 11
368 | while participants were inpatient, and at Days 15 and 29, with the Day 1
369 | assessment serving as baseline. Participants who had been discharged had
370 | blood collected if infection control measures allowed for in-person
371 | visits after discharge.
372 | Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
373 |
374 | #### Secondary Outcomes
375 | Measure: Change From Baseline in Lymphocytes
376 | Description:
377 | Blood to evaluate lymphocytes was collected at Days 1, 3, 5, 8, and 11
378 | while participants were inpatient, and at Days 15 and 29, with the Day 1
379 | assessment serving as baseline. Participants who had been discharged had
380 | blood collected if infection control measures allowed for in-person
381 | visits after discharge.
382 | Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
383 |
384 | #### Secondary Outcomes
385 | Measure: Change From Baseline in Monocytes
386 | Description:
387 | Blood to evaluate monocytes was collected at Days 1, 3, 5, 8, and 11
388 | while participants were inpatient, and at Days 15 and 29, with the Day 1
389 | assessment serving as baseline. Participants who had been discharged had
390 | blood collected if infection control measures allowed for in-person
391 | visits after discharge.
392 | Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
393 |
394 | #### Secondary Outcomes
395 | Measure: Change From Baseline in Basophils
396 | Description:
397 | Blood to evaluate basophils was collected at Days 1, 3, 5, 8, and 11
398 | while participants were inpatient, and at Days 15 and 29, with the Day 1
399 | assessment serving as baseline. Participants who had been discharged had
400 | blood collected if infection control measures allowed for in-person
401 | visits after discharge.
402 | Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
403 |
404 | #### Secondary Outcomes
405 | Measure: Change From Baseline in Eosinophils
406 | Description:
407 | Blood to evaluate eosinophils was collected at Days 1, 3, 5, 8, and 11
408 | while participants were inpatient, and at Days 15 and 29, with the Day 1
409 | assessment serving as baseline. Participants who had been discharged had
410 | blood collected if infection control measures allowed for in-person
411 | visits after discharge.
412 | Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
413 |
414 | #### Secondary Outcomes
415 | Measure: Change in National Early Warning Score (NEWS) From Baseline
416 | Description:
417 | The NEW score has demonstrated an ability to discriminate patients at
418 | risk of poor outcomes. This score is based on 7 clinical parameters
419 | (respiration rate, oxygen saturation, any supplemental oxygen,
420 | temperature, systolic blood pressure, heart rate, level of
421 | consciousness). The NEW Score is being used as an efficacy measure. The
422 | minimum score is 0, representing the better outcome, and the maximum
423 | value is 19, representing the worse outcome.
424 | Time Frame: Days 1, 3, 5, 8, 11, 15, 22, and 29
425 |
426 | #### Secondary Outcomes
427 | Measure:
428 | Percentage of Participants at Each Clinical Status Using Ordinal Scale
429 | at Day 1
430 | Description:
431 | The ordinal scale is an assessment of the clinical status at the first
432 | assessment of a given study day. The scale is as follows: 8) Death; 7)
433 | Hospitalized, on invasive mechanical ventilation or extracorporeal
434 | membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
435 | ventilation or high flow oxygen devices; 5) Hospitalized, requiring
436 | supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
437 | - requiring ongoing medical care (COVID-19 related or otherwise); 3)
438 | Hospitalized, not requiring supplemental oxygen - no longer requires
439 | ongoing medical care; 2) Not hospitalized, limitation on activities
440 | and/or requiring home oxygen; 1) Not hospitalized, no limitations on
441 | activities.
442 | Time Frame: Day 1
443 |
444 | #### Secondary Outcomes
445 | Measure:
446 | Percentage of Participants at Each Clinical Status Using Ordinal Scale
447 | at Day 3
448 | Description:
449 | The ordinal scale is an assessment of the clinical status at the first
450 | assessment of a given study day. The scale is as follows: 8) Death; 7)
451 | Hospitalized, on invasive mechanical ventilation or extracorporeal
452 | membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
453 | ventilation or high flow oxygen devices; 5) Hospitalized, requiring
454 | supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
455 | - requiring ongoing medical care (COVID-19 related or otherwise); 3)
456 | Hospitalized, not requiring supplemental oxygen - no longer requires
457 | ongoing medical care; 2) Not hospitalized, limitation on activities
458 | and/or requiring home oxygen; 1) Not hospitalized, no limitations on
459 | activities.
460 | Time Frame: Day 3
461 |
462 | #### Secondary Outcomes
463 | Measure:
464 | Percentage of Participants at Each Clinical Status Using Ordinal Scale
465 | at Day 5
466 | Description:
467 | The ordinal scale is an assessment of the clinical status at the first
468 | assessment of a given study day. The scale is as follows: 8) Death; 7)
469 | Hospitalized, on invasive mechanical ventilation or extracorporeal
470 | membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
471 | ventilation or high flow oxygen devices; 5) Hospitalized, requiring
472 | supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
473 | - requiring ongoing medical care (COVID-19 related or otherwise); 3)
474 | Hospitalized, not requiring supplemental oxygen - no longer requires
475 | ongoing medical care; 2) Not hospitalized, limitation on activities
476 | and/or requiring home oxygen; 1) Not hospitalized, no limitations on
477 | activities.
478 | Time Frame: Day 5
479 |
480 | #### Secondary Outcomes
481 | Measure:
482 | Percentage of Participants at Each Clinical Status Using Ordinal Scale
483 | at Day 8
484 | Description:
485 | The ordinal scale is an assessment of the clinical status at the first
486 | assessment of a given study day. The scale is as follows: 8) Death; 7)
487 | Hospitalized, on invasive mechanical ventilation or extracorporeal
488 | membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
489 | ventilation or high flow oxygen devices; 5) Hospitalized, requiring
490 | supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
491 | - requiring ongoing medical care (COVID-19 related or otherwise); 3)
492 | Hospitalized, not requiring supplemental oxygen - no longer requires
493 | ongoing medical care; 2) Not hospitalized, limitation on activities
494 | and/or requiring home oxygen; 1) Not hospitalized, no limitations on
495 | activities.
496 | Time Frame: Day 8
497 |
498 | #### Secondary Outcomes
499 | Measure:
500 | Percentage of Participants at Each Clinical Status Using Ordinal Scale
501 | at Day 11
502 | Description:
503 | The ordinal scale is an assessment of the clinical status at the first
504 | assessment of a given study day. The scale is as follows: 8) Death; 7)
505 | Hospitalized, on invasive mechanical ventilation or extracorporeal
506 | membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
507 | ventilation or high flow oxygen devices; 5) Hospitalized, requiring
508 | supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
509 | - requiring ongoing medical care (COVID-19 related or otherwise); 3)
510 | Hospitalized, not requiring supplemental oxygen - no longer requires
511 | ongoing medical care; 2) Not hospitalized, limitation on activities
512 | and/or requiring home oxygen; 1) Not hospitalized, no limitations on
513 | activities.
514 | Time Frame: Day 11
515 |
516 | #### Secondary Outcomes
517 | Measure:
518 | Percentage of Participants at Each Clinical Status Using Ordinal Scale
519 | at Day 15
520 | Description:
521 | The ordinal scale is an assessment of the clinical status at the first
522 | assessment of a given study day. The scale is as follows: 8) Death; 7)
523 | Hospitalized, on invasive mechanical ventilation or extracorporeal
524 | membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
525 | ventilation or high flow oxygen devices; 5) Hospitalized, requiring
526 | supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
527 | - requiring ongoing medical care (COVID-19 related or otherwise); 3)
528 | Hospitalized, not requiring supplemental oxygen - no longer requires
529 | ongoing medical care; 2) Not hospitalized, limitation on activities
530 | and/or requiring home oxygen; 1) Not hospitalized, no limitations on
531 | activities.
532 | Time Frame: Day 15
533 |
534 | #### Secondary Outcomes
535 | Measure:
536 | Percentage of Participants at Each Clinical Status Using Ordinal Scale
537 | at Day 22
538 | Description:
539 | The ordinal scale is an assessment of the clinical status at the first
540 | assessment of a given study day. The scale is as follows: 8) Death; 7)
541 | Hospitalized, on invasive mechanical ventilation or extracorporeal
542 | membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
543 | ventilation or high flow oxygen devices; 5) Hospitalized, requiring
544 | supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
545 | - requiring ongoing medical care (COVID-19 related or otherwise); 3)
546 | Hospitalized, not requiring supplemental oxygen - no longer requires
547 | ongoing medical care; 2) Not hospitalized, limitation on activities
548 | and/or requiring home oxygen; 1) Not hospitalized, no limitations on
549 | activities.
550 | Time Frame: Day 22
551 |
552 | #### Secondary Outcomes
553 | Measure:
554 | Percentage of Participants at Each Clinical Status Using Ordinal Scale
555 | at Day 29
556 | Description:
557 | The ordinal scale is an assessment of the clinical status at the first
558 | assessment of a given study day. The scale is as follows: 8) Death; 7)
559 | Hospitalized, on invasive mechanical ventilation or extracorporeal
560 | membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
561 | ventilation or high flow oxygen devices; 5) Hospitalized, requiring
562 | supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
563 | - requiring ongoing medical care (COVID-19 related or otherwise); 3)
564 | Hospitalized, not requiring supplemental oxygen - no longer requires
565 | ongoing medical care; 2) Not hospitalized, limitation on activities
566 | and/or requiring home oxygen; 1) Not hospitalized, no limitations on
567 | activities.
568 | Time Frame: Day 29
569 |
570 | #### Secondary Outcomes
571 | Measure:
572 | Percentage of Participants Reporting Grade 3 and 4 Clinical and/or
573 | Laboratory Adverse Events (AEs)
574 | Description:
575 | Grade 3 AEs are defined as events that interrupt usual activities of
576 | daily living, or significantly affects clinical status, or may require
577 | intensive therapeutic intervention. Severe events are usually
578 | incapacitating. Grade 4 AEs are defined as events that are potentially
579 | life threatening.
580 | Time Frame: Day 1 through Day 29
581 |
582 | #### Secondary Outcomes
583 | Measure: Percentage of Participants Reporting Serious Adverse Events (SAEs)
584 | Description:
585 | An SAE is defined as an AE or suspected adverse reaction is considered
586 | serious if, in the view of either the investigator or the sponsor, it
587 | results in death, a life-threatening AE, inpatient hospitalization or
588 | prolongation of existing hospitalization, a persistent or significant
589 | incapacity or substantial disruption of the ability to conduct normal
590 | life functions, or a congenital anomaly/birth defect.
591 | Time Frame: Day 1 through Day 29
592 |
593 | #### Secondary Outcomes
594 | Measure:
595 | Percentage of Participants Discontinued or Temporarily Suspended From
596 | Investigational Therapeutics
597 | Description:
598 | Participants may have been discontinued from investigational
599 | therapeutics due to discharge or death. The halting or slowing of the
600 | infusion for any reason was collected, as was missed doses in the series
601 | of 10 doses.
602 | Time Frame: Day 1 through Day 10
603 |
604 | #### Secondary Outcomes
605 | Measure: Duration of Hospitalization
606 | Description:
607 | Duration of hospitalization was determined two ways. The first includes
608 | imputations for participants who died. The second method is restricted
609 | to participants who did not die.
610 | Time Frame: Day 1 through Day 29
611 |
612 | #### Secondary Outcomes
613 | Measure: Duration of New Non-invasive Ventilation or High Flow Oxygen Use
614 | Description:
615 | Duration of new non-invasive ventilation or high flow oxygen use was
616 | measured in days among participants who were not on non-invasive
617 | ventilation or high-flow oxygen use at baseline, determined two ways.
618 | The first includes imputations for participants who died. The second
619 | method is restricted to participants who did not die
620 | Time Frame: Day 1 through Day 29
621 |
622 | #### Secondary Outcomes
623 | Measure: Duration of New Oxygen Use
624 | Description:
625 | Duration of new oxygen use was measured in days among participants who
626 | were not on oxygen at baseline, determined two ways. The first includes
627 | imputations for participants who died. The second method is restricted
628 | to participants who did not die
629 |
630 | .
631 | Time Frame: Day 1 through Day 29
632 |
633 | #### Secondary Outcomes
634 | Measure:
635 | Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO)
636 | Use
637 | Description:
638 | Duration of new ventilator or ECMO use was measured in days among
639 | participants who were not on a ventilator or ECMO at baseline,
640 | determined two ways. The first includes imputations for participants who
641 | died. The second method is restricted to participants who did not die
642 | Time Frame: Day 1 through Day 29
643 |
644 | #### Secondary Outcomes
645 | Measure:
646 | Percentage of Participants Requiring New Non-invasive Ventilation or
647 | High-flow Oxygen Use
648 | Description:
649 | New non-invasive ventilation or high-flow oxygen use was determined as
650 | the percentage of subject not on non-invasive ventilation or high-flow
651 | oxygen at baseline.
652 | Time Frame: Day 1 through Day 29
653 |
654 | #### Secondary Outcomes
655 | Measure: Percentage of Participants Requiring New Oxygen Use
656 | Description:
657 | The percentage of participants requiring new oxygen use was determined
658 | as the percentage of participants not requiring oxygen at baseline
659 | Time Frame: Day 1 through Day 29
660 |
661 | #### Secondary Outcomes
662 | Measure:
663 | Percentage of Participants Requiring New Ventilator or Extracorporeal
664 | Membrane Oxygenation (ECMO) Use
665 | Description:
666 | The percentage of participants requiring new ventilator or ECMO use was
667 | determined as the percentage not on a ventilator or ECMO at baseline
668 | Time Frame: Day 1 through Day 29
669 |
670 | #### Secondary Outcomes
671 | Measure: Mean Change in the Ordinal Scale
672 | Description:
673 | The ordinal scale is an assessment of the clinical status at the first
674 | assessment of a given study day. The scale is as follows: 8) Death; 7)
675 | Hospitalized, on invasive mechanical ventilation or extracorporeal
676 | membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
677 | ventilation or high flow oxygen devices; 5) Hospitalized, requiring
678 | supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
679 | - requiring ongoing medical care (COVID-19 related or otherwise); 3)
680 | Hospitalized, not requiring supplemental oxygen - no longer requires
681 | ongoing medical care; 2) Not hospitalized, limitation on activities
682 | and/or requiring home oxygen; 1) Not hospitalized, no limitations on
683 | activities. A positive change indicates a worsening and a negative
684 | change is an improvement.
685 | Time Frame: Day 1, 3, 5, 8, 11, 15, 22, and 29
686 |
687 | #### Secondary Outcomes
688 | Measure: 14-day Participant Mortality
689 | Description:
690 | The mortality rate was determined as the proportion of participants who
691 | died by study Day 15.
692 | Time Frame: Day 1 through Day 15
693 |
694 | #### Secondary Outcomes
695 | Measure: 29-day Participant Mortality
696 | Description:
697 | The mortality rate was determined as the proportion of participants who
698 | died by study Day 29.
699 | Time Frame: Day 1 through Day 29
700 |
701 | #### Secondary Outcomes
702 | Measure: Time to an Improvement by at Least One Category Using an Ordinal Scale
703 | Description:
704 | The ordinal scale is an assessment of the clinical status at the first
705 | assessment of a given study day. The scale is as follows: 8) Death; 7)
706 | Hospitalized, on invasive mechanical ventilation or extracorporeal
707 | membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
708 | ventilation or high flow oxygen devices; 5) Hospitalized, requiring
709 | supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
710 | - requiring ongoing medical care (COVID-19 related or otherwise); 3)
711 | Hospitalized, not requiring supplemental oxygen - no longer requires
712 | ongoing medical care; 2) Not hospitalized, limitation on activities
713 | and/or requiring home oxygen; 1) Not hospitalized, no limitations on
714 | activities. Time to improvement by at least one category was determined
715 | for each participant
716 | Time Frame: Day 1 through Day 29
717 |
718 | #### Secondary Outcomes
719 | Measure: Time to an Improvement of at Least Two Categories Using an Ordinal Scale
720 | Description:
721 | The ordinal scale is an assessment of the clinical status at the first
722 | assessment of a given study day. The scale is as follows: 1) Death; 2)
723 | Hospitalized, on invasive mechanical ventilation or extracorporeal
724 | membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive
725 | ventilation or high flow oxygen devices; 4) Hospitalized, requiring
726 | supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen
727 | - requiring ongoing medical care (COVID-19 related or otherwise); 6)
728 | Hospitalized, not requiring supplemental oxygen - no longer requires
729 | ongoing medical care; 7) Not hospitalized, limitation on activities
730 | and/or requiring home oxygen; 8) Not hospitalized, no limitations on
731 | activities. Time to improvement by at least two categories was
732 | determined for each participant
733 | Time Frame: Day 1 through Day 29
734 |
735 | #### Secondary Outcomes
736 | Measure:
737 | Time to Discharge or to a NEWS of 2 or Less and Maintained for 24 Hours,
738 | Whichever Occurs First
739 | Description:
740 | The NEW score has demonstrated an ability to discriminate patients at
741 | risk of poor outcomes. This score is based on 7 clinical parameters
742 | (respiration rate, oxygen saturation, any supplemental oxygen,
743 | temperature, systolic blood pressure, heart rate, level of
744 | consciousness). The NEW Score is being used as an efficacy measure. The
745 | minimum score is 0, representing the better outcome, and the maximum
746 | value is 19, representing the worse outcome. The time to discharge or a
747 | NEWS of less than or equal to 2 was determined for each participant.
748 | Time Frame: Day 1 through Day 29
749 |
750 | ### Eligibility Module
751 | Eligibility Criteria:
752 | Inclusion Criteria:
753 |
754 | 1. Admitted to a hospital with symptoms suggestive of COVID-19
755 | infection.
756 | 2. Subject (or legally authorized representative) provides informed
757 | consent prior to initiation of any study procedures.
758 | 3. Subject (or legally authorized representative) understands and agrees
759 | to comply with planned study procedures.
760 | 4. Male or non-pregnant female adult \> / = 18 years of age at time of
761 | enrollment.
762 | 5. Has laboratory-confirmed SARS-CoV-2 infection as determined by
763 | polymerase chain reaction (PCR) or other commercial or public health
764 | assay in any specimen, as documented by either or the following:
765 |
766 | 1. PCR positive in sample collected \< 72 hours prior to randomization;
767 | OR
768 |
769 | Exclusion Criteria:
770 | 2. PCR positive in sample collected \>/= 72 hours prior to
771 | randomization, documented inability to obtain a repeat sample (e.g. due
772 | to lack of testing supplies, limited testing capacity, results taking
773 | \>24 hours, etc.) AND progressive disease suggestive of ongoing SARS-
774 | CoV-2 infection.
775 | 6. Illness of any duration, and at least one of the following:
776 |
777 | 1. Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR
778 | 2. SpO2 \< / = 94% on room air, OR
779 | 3. Requiring supplemental oxygen, OR
780 | 4. Requiring mechanical ventilation.
781 | 7. Women of childbearing potential must agree to either abstinence or
782 | use at least one primary form of contraception not including hormonal
783 | contraception from the time of screening through Day 29.
784 | 8. Agrees to not participate in another clinical trial for the treatment
785 | of COVID-19 or SARS-CoV-2 through Day 29.
786 |
787 | Exclusion Criteria:
788 |
789 | 1. Alanine Transaminase (ALT) or Aspartate Transaminase (AST) \> 5 times
790 | the upper limit of normal.
791 | 2. Estimated glomerular filtration rate (eGFR) \< 30 ml/min (including
792 | patients receiving hemodialysis or hemofiltration).
793 | 3. Pregnancy or breast feeding.
794 | 4. Anticipated discharge from the hospital or transfer to another
795 | hospital which is not a study site within 72 hours.
796 | 5. Allergy to any study medication.
797 | Healthy Volunteers: False
798 | Sex: ALL
799 | Minimum Age: 18 Years
800 | Maximum Age: 99 Years
801 | Std Ages: ADULT, OLDER_ADULT
802 |
803 | ### Contacts Locations Module
804 |
805 | #### Locations
806 | Facility:
807 | University of Alabama at Birmingham School of Medicine - Infectious
808 | Disease
809 | City: Birmingham
810 | State: Alabama
811 | Zip: 35233
812 | Country: United States
813 |
814 | ##### Geo Point
815 | Lat: 33.52066
816 | Lon: -86.80249
817 |
818 | #### Locations
819 | Facility: University of California San Diego Health - Jacobs Medical Center
820 | City: La Jolla
821 | State: California
822 | Zip: 29037
823 | Country: United States
824 |
825 | ##### Geo Point
826 | Lat: 32.84727
827 | Lon: -117.2742
828 |
829 | #### Locations
830 | Facility: University of California Los Angeles Medical Center - Westwood Clinic
831 | City: Los Angeles
832 | State: California
833 | Zip: 90095
834 | Country: United States
835 |
836 | ##### Geo Point
837 | Lat: 34.05223
838 | Lon: -118.24368
839 |
840 | #### Locations
841 | Facility: University of California Irvine Medical Center - Infectious Disease
842 | City: Orange
843 | State: California
844 | Zip: 92868-3298
845 | Country: United States
846 |
847 | ##### Geo Point
848 | Lat: 33.78779
849 | Lon: -117.85311
850 |
851 | #### Locations
852 | Facility: VA Palo Alto Health Care System - Infectious Diseases
853 | City: Palo Alto
854 | State: California
855 | Zip: 94304-1207
856 | Country: United States
857 |
858 | ##### Geo Point
859 | Lat: 37.44188
860 | Lon: -122.14302
861 |
862 | #### Locations
863 | Facility:
864 | University of California Davis Medical Center - Internal Medicine -
865 | Infectious Disease
866 | City: Sacramento
867 | State: California
868 | Zip: 95817-1460
869 | Country: United States
870 |
871 | ##### Geo Point
872 | Lat: 38.58157
873 | Lon: -121.4944
874 |
875 | #### Locations
876 | Facility: Naval Medical Center San Diego - Infectious Disease Clinic
877 | City: San Diego
878 | State: California
879 | Zip: 92314
880 | Country: United States
881 |
882 | ##### Geo Point
883 | Lat: 32.71533
884 | Lon: -117.15726
885 |
886 | #### Locations
887 | Facility:
888 | University of California San Francisco - Zuckerberg San Francisco
889 | General Hospital - Division of Human Immunodeficiency Virus, Infectious
890 | Disease, and Global Medicine
891 | City: San Francisco
892 | State: California
893 | Zip: 94110-2859
894 | Country: United States
895 |
896 | ##### Geo Point
897 | Lat: 37.77493
898 | Lon: -122.41942
899 |
900 | #### Locations
901 | Facility:
902 | Stanford University - Stanford Hospital and Clinics - Pediatrics -
903 | Infectious Diseases
904 | City: Stanford
905 | State: California
906 | Zip: 94305-2200
907 | Country: United States
908 |
909 | ##### Geo Point
910 | Lat: 37.42411
911 | Lon: -122.16608
912 |
913 | #### Locations
914 | Facility: Cedars Sinai Medical Center
915 | City: West Hollywood
916 | State: California
917 | Zip: 90048-1804
918 | Country: United States
919 |
920 | ##### Geo Point
921 | Lat: 34.09001
922 | Lon: -118.36174
923 |
924 | #### Locations
925 | Facility: Denver Health Division of Hospital Medicine - Main Campus
926 | City: Denver
927 | State: Colorado
928 | Zip: 80204
929 | Country: United States
930 |
931 | ##### Geo Point
932 | Lat: 39.73915
933 | Lon: -104.9847
934 |
935 | #### Locations
936 | Facility: Emory Vaccine Center - The Hope Clinic
937 | City: Decatur
938 | State: Georgia
939 | Zip: 30030-1705
940 | Country: United States
941 |
942 | ##### Geo Point
943 | Lat: 33.77483
944 | Lon: -84.29631
945 |
946 | #### Locations
947 | Facility: Northwestern Hospital - Infectious Disease
948 | City: Chicago
949 | State: Illinois
950 | Zip: 60611-2908
951 | Country: United States
952 |
953 | ##### Geo Point
954 | Lat: 41.85003
955 | Lon: -87.65005
956 |
957 | #### Locations
958 | Facility:
959 | University of Illinois at Chicago College of Medicine - Division of
960 | Infectious Diseases
961 | City: Chicago
962 | State: Illinois
963 | Zip: 60612
964 | Country: United States
965 |
966 | ##### Geo Point
967 | Lat: 41.85003
968 | Lon: -87.65005
969 |
970 | #### Locations
971 | Facility:
972 | Southeast Louisiana Veterans Health Care System - Section of Infectious
973 | Diseases
974 | City: New Orleans
975 | State: Louisiana
976 | Zip: 70119
977 | Country: United States
978 |
979 | ##### Geo Point
980 | Lat: 29.95465
981 | Lon: -90.07507
982 |
983 | #### Locations
984 | Facility:
985 | University of Maryland School of Medicine - Center for Vaccine
986 | Development - Baltimore
987 | City: Baltimore
988 | State: Maryland
989 | Zip: 21201-1509
990 | Country: United States
991 |
992 | ##### Geo Point
993 | Lat: 39.29038
994 | Lon: -76.61219
995 |
996 | #### Locations
997 | Facility: Johns Hopkins Hospital - Medicine - Infectious Diseases
998 | City: Baltimore
999 | State: Maryland
1000 | Zip: 21287-0005
1001 | Country: United States
1002 |
1003 | ##### Geo Point
1004 | Lat: 39.29038
1005 | Lon: -76.61219
1006 |
1007 | #### Locations
1008 | Facility: Walter Reed National Military Medical Center
1009 | City: Bethesda
1010 | State: Maryland
1011 | Zip: 20889
1012 | Country: United States
1013 |
1014 | ##### Geo Point
1015 | Lat: 38.98067
1016 | Lon: -77.10026
1017 |
1018 | #### Locations
1019 | Facility:
1020 | National Institutes of Health - Clinical Center, National Institute of
1021 | Allergy and Infectious Diseases Laboratory Of Immunoregulation, Clinical
1022 | Research Section
1023 | City: Bethesda
1024 | State: Maryland
1025 | Zip: 20892-1504
1026 | Country: United States
1027 |
1028 | ##### Geo Point
1029 | Lat: 38.98067
1030 | Lon: -77.10026
1031 |
1032 | #### Locations
1033 | Facility: Massachusetts General Hospital - Infectious Diseases
1034 | City: Boston
1035 | State: Massachusetts
1036 | Zip: 02114-2621
1037 | Country: United States
1038 |
1039 | ##### Geo Point
1040 | Lat: 42.35843
1041 | Lon: -71.05977
1042 |
1043 | #### Locations
1044 | Facility:
1045 | University of Massachusetts Medical School - Infectious Diseases and
1046 | Immunology
1047 | City: Worcester
1048 | State: Massachusetts
1049 | Zip: 01655-0002
1050 | Country: United States
1051 |
1052 | ##### Geo Point
1053 | Lat: 42.26259
1054 | Lon: -71.80229
1055 |
1056 | #### Locations
1057 | Facility:
1058 | University of Minnesota Medical Center, Fairview - Infectious Diseases
1059 | and International Medicine
1060 | City: Minneapolis
1061 | State: Minnesota
1062 | Zip: 55455-0341
1063 | Country: United States
1064 |
1065 | ##### Geo Point
1066 | Lat: 44.97997
1067 | Lon: -93.26384
1068 |
1069 | #### Locations
1070 | Facility: Saint Louis University - Center for Vaccine Development
1071 | City: Saint Louis
1072 | State: Missouri
1073 | Zip: 63104-1015
1074 | Country: United States
1075 |
1076 | ##### Geo Point
1077 | Lat: 38.62727
1078 | Lon: -90.19789
1079 |
1080 | #### Locations
1081 | Facility: University of Nebraska Medical Center - Infectious Diseases
1082 | City: Omaha
1083 | State: Nebraska
1084 | Zip: 68105
1085 | Country: United States
1086 |
1087 | ##### Geo Point
1088 | Lat: 41.25626
1089 | Lon: -95.94043
1090 |
1091 | #### Locations
1092 | Facility: Montefiore Medical Center - Infectious Diseases
1093 | City: Bronx
1094 | State: New York
1095 | Zip: 10467-2401
1096 | Country: United States
1097 |
1098 | ##### Geo Point
1099 | Lat: 40.84985
1100 | Lon: -73.86641
1101 |
1102 | #### Locations
1103 | Facility:
1104 | New York University School of Medicine - Langone Medical Center -
1105 | Microbiology - Parasitology
1106 | City: New York
1107 | State: New York
1108 | Zip: 10016-6402
1109 | Country: United States
1110 |
1111 | ##### Geo Point
1112 | Lat: 40.71427
1113 | Lon: -74.00597
1114 |
1115 | #### Locations
1116 | Facility: University of Rochester Medical Center - Vaccine Research Unit
1117 | City: Rochester
1118 | State: New York
1119 | Zip: 14642-0001
1120 | Country: United States
1121 |
1122 | ##### Geo Point
1123 | Lat: 43.15478
1124 | Lon: -77.61556
1125 |
1126 | #### Locations
1127 | Facility: Duke Human Vaccine Institute - Duke Vaccine and Trials Unit
1128 | City: Durham
1129 | State: North Carolina
1130 | Zip: 27704
1131 | Country: United States
1132 |
1133 | ##### Geo Point
1134 | Lat: 35.99403
1135 | Lon: -78.89862
1136 |
1137 | #### Locations
1138 | Facility:
1139 | Penn State Health Milton S. Hershey Medical Center - Division of
1140 | Infectious Diseases
1141 | City: Hershey
1142 | State: Pennsylvania
1143 | Zip: 17033
1144 | Country: United States
1145 |
1146 | ##### Geo Point
1147 | Lat: 40.28592
1148 | Lon: -76.65025
1149 |
1150 | #### Locations
1151 | Facility: Hospital of the University of Pennsylvania - Infectious Diseases
1152 | City: Philadelphia
1153 | State: Pennsylvania
1154 | Zip: 19104-4238
1155 | Country: United States
1156 |
1157 | ##### Geo Point
1158 | Lat: 39.95233
1159 | Lon: -75.16379
1160 |
1161 | #### Locations
1162 | Facility: Vanderbilt University Medical Center - Infectious Diseases
1163 | City: Nashville
1164 | State: Tennessee
1165 | Zip: 37232-0011
1166 | Country: United States
1167 |
1168 | ##### Geo Point
1169 | Lat: 36.16589
1170 | Lon: -86.78444
1171 |
1172 | #### Locations
1173 | Facility: Brooke Army Medical Center
1174 | City: Fort Sam Houston
1175 | State: Texas
1176 | Zip: 78234
1177 | Country: United States
1178 |
1179 | ##### Geo Point
1180 | Lat: 29.45746
1181 | Lon: -98.4472
1182 |
1183 | #### Locations
1184 | Facility: University of Texas Medical Branch - Division of Infectious Disease
1185 | City: Galveston
1186 | State: Texas
1187 | Zip: 77555-0435
1188 | Country: United States
1189 |
1190 | ##### Geo Point
1191 | Lat: 29.30135
1192 | Lon: -94.7977
1193 |
1194 | #### Locations
1195 | Facility: Baylor College of Medicine - Molecular Virology and Microbiology
1196 | City: Houston
1197 | State: Texas
1198 | Zip: 77030-3411
1199 | Country: United States
1200 |
1201 | ##### Geo Point
1202 | Lat: 29.76328
1203 | Lon: -95.36327
1204 |
1205 | #### Locations
1206 | Facility:
1207 | University of Texas Health Science Center at San Antonio - Infectious
1208 | Diseases
1209 | City: San Antonio
1210 | State: Texas
1211 | Zip: 78229-3901
1212 | Country: United States
1213 |
1214 | ##### Geo Point
1215 | Lat: 29.42412
1216 | Lon: -98.49363
1217 |
1218 | #### Locations
1219 | Facility: University of Virginia - Acute Care Surgery
1220 | City: Charlottesville
1221 | State: Virginia
1222 | Zip: 22908-0816
1223 | Country: United States
1224 |
1225 | ##### Geo Point
1226 | Lat: 38.02931
1227 | Lon: -78.47668
1228 |
1229 | #### Locations
1230 | Facility: Naval Medical Center Portsmouth - Infectious Disease Division
1231 | City: Portsmouth
1232 | State: Virginia
1233 | Zip: 23708
1234 | Country: United States
1235 |
1236 | ##### Geo Point
1237 | Lat: 36.83543
1238 | Lon: -76.29827
1239 |
1240 | #### Locations
1241 | Facility: EvergreenHealth Infectious Disease Service
1242 | City: Kirkland
1243 | State: Washington
1244 | Zip: 98034
1245 | Country: United States
1246 |
1247 | ##### Geo Point
1248 | Lat: 47.68149
1249 | Lon: -122.20874
1250 |
1251 | #### Locations
1252 | Facility: The University of Washington - Virology Research Clinic
1253 | City: Seattle
1254 | State: Washington
1255 | Zip: 98104
1256 | Country: United States
1257 |
1258 | ##### Geo Point
1259 | Lat: 47.60621
1260 | Lon: -122.33207
1261 |
1262 | #### Locations
1263 | Facility: Providence Sacred Heart Medical Center
1264 | City: Spokane
1265 | State: Washington
1266 | Zip: 99204
1267 | Country: United States
1268 |
1269 | ##### Geo Point
1270 | Lat: 47.65966
1271 | Lon: -117.42908
1272 |
1273 | #### Locations
1274 | Facility: Madigan Army Medical Center - Infectious Disease Clinic
1275 | City: Tacoma
1276 | State: Washington
1277 | Zip: 98431
1278 | Country: United States
1279 |
1280 | ##### Geo Point
1281 | Lat: 47.25288
1282 | Lon: -122.44429
1283 |
1284 | #### Locations
1285 | Facility:
1286 | University of Copenhagen - Centre of Excellence for Health, Immunity and
1287 | Infections (CHIP) - Department of Infectious Diseases
1288 | City: Copenhagen
1289 | Zip: 2100
1290 | Country: Denmark
1291 |
1292 | ##### Geo Point
1293 | Lat: 55.67594
1294 | Lon: 12.56553
1295 |
1296 | #### Locations
1297 | Facility:
1298 | Universitatsklinikum Bonn, Medizinische Klinik I - Bereich
1299 | Infektiologie/HIV der Medizinischen Klinik
1300 | City: Bonn
1301 | State: Nordrhein-Westfalen
1302 | Zip: 53127
1303 | Country: Germany
1304 |
1305 | ##### Geo Point
1306 | Lat: 50.73438
1307 | Lon: 7.09549
1308 |
1309 | #### Locations
1310 | Facility:
1311 | Universitatsklinikum Koeln Klinik I fur Innere Medizin Klinisches
1312 | Studienzentrum fur Infektiologie I
1313 | City: Cologne
1314 | Zip: 50937
1315 | Country: Germany
1316 |
1317 | ##### Geo Point
1318 | Lat: 50.93333
1319 | Lon: 6.95
1320 |
1321 | #### Locations
1322 | Facility: Universitätsklinikum Frankfurt -Medizinische Klinik II - Infektiologie
1323 | City: Frankfurt
1324 | Zip: 60590
1325 | Country: Germany
1326 |
1327 | ##### Geo Point
1328 | Lat: 50.11552
1329 | Lon: 8.68417
1330 |
1331 | #### Locations
1332 | Facility: AHEPA University Hospital - 1st Department of Internal Medicine
1333 | City: Thessaloniki
1334 | State: Central Macedonia
1335 | Zip: P.O. 54636
1336 | Country: Greece
1337 |
1338 | ##### Geo Point
1339 | Lat: 40.64361
1340 | Lon: 22.93086
1341 |
1342 | #### Locations
1343 | Facility:
1344 | Medical School of Athens University - Evangelismos Hospital - Department
1345 | of Critical Care and Pulmonary Services
1346 | City: Athens
1347 | Zip: GR-10675
1348 | Country: Greece
1349 |
1350 | ##### Geo Point
1351 | Lat: 37.97945
1352 | Lon: 23.71622
1353 |
1354 | #### Locations
1355 | Facility:
1356 | National Center for Global Health and Medicine Hospital - Disease
1357 | Control and Prevention Center
1358 | City: Tokyo
1359 | Zip: 162-8655
1360 | Country: Japan
1361 |
1362 | ##### Geo Point
1363 | Lat: 35.6895
1364 | Lon: 139.69171
1365 |
1366 | #### Locations
1367 | Facility:
1368 | Seoul National University Bundang Hospital - Division of Infectious
1369 | Diseases
1370 | City: Bundang-gu Seongnam-si
1371 | State: Gyeonggi-do
1372 | Zip: 13620
1373 | Country: Korea, Republic of
1374 |
1375 | #### Locations
1376 | Facility: Seoul National University Hospital
1377 | City: Seoul
1378 | State: Jongno-gu
1379 | Zip: 03080
1380 | Country: Korea, Republic of
1381 |
1382 | ##### Geo Point
1383 | Lat: 37.566
1384 | Lon: 126.9784
1385 |
1386 | #### Locations
1387 | Facility:
1388 | Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán -
1389 | Departamento de Infectologia
1390 | City: Mexico City
1391 | Zip: 14080
1392 | Country: Mexico
1393 |
1394 | ##### Geo Point
1395 | Lat: 19.42847
1396 | Lon: -99.12766
1397 |
1398 | #### Locations
1399 | Facility:
1400 | Instituto Nacional de Enfermedades Respiratorias (INER) - Ismael Cosío
1401 | Villegas
1402 | City: Mexico City
1403 | Zip: 14080
1404 | Country: Mexico
1405 |
1406 | ##### Geo Point
1407 | Lat: 19.42847
1408 | Lon: -99.12766
1409 |
1410 | #### Locations
1411 | Facility: National Centre for Infectious Diseases
1412 | City: Singapore
1413 | Zip: 308442
1414 | Country: Singapore
1415 |
1416 | ##### Geo Point
1417 | Lat: 1.28967
1418 | Lon: 103.85007
1419 |
1420 | #### Locations
1421 | Facility: Hospital Clinic Barcelona, Servicio de Salud Internacional
1422 | City: Barcelona
1423 | State: Cataluña
1424 | Zip: 08036
1425 | Country: Spain
1426 |
1427 | ##### Geo Point
1428 | Lat: 41.38879
1429 | Lon: 2.15899
1430 |
1431 | #### Locations
1432 | Facility: Hospital Germans Trias i Pujol - Servei Malalties Infeccioses
1433 | City: Barcelona
1434 | State: Cataluña
1435 | Zip: 08916
1436 | Country: Spain
1437 |
1438 | ##### Geo Point
1439 | Lat: 41.38879
1440 | Lon: 2.15899
1441 |
1442 | #### Locations
1443 | Facility: Royal Sussex County Hospital - Department of Intensive Care Medicine
1444 | City: East Sussex
1445 | State: Brighton
1446 | Zip: BN2 5BE
1447 | Country: United Kingdom
1448 |
1449 | #### Locations
1450 | Facility: Saint Thomas' Hospital - Directorate of Infection
1451 | City: London
1452 | State: London, City Of
1453 | Zip: SE1 7EH
1454 | Country: United Kingdom
1455 |
1456 | ##### Geo Point
1457 | Lat: 51.50853
1458 | Lon: -0.12574
1459 |
1460 | #### Locations
1461 | Facility: Royal Victoria Infirmary - Department of Infectious Diseases
1462 | City: Level 6, Ward 19
1463 | State: Newcastle Upon Tyne
1464 | Zip: NE1 4LP
1465 | Country: United Kingdom
1466 |
1467 | #### Locations
1468 | Facility: St. James's University Hospital - Infectious Diseases
1469 | City: Leeds
1470 | State: West Yorkshire
1471 | Zip: LS9 7TK
1472 | Country: United Kingdom
1473 |
1474 | ##### Geo Point
1475 | Lat: 53.79648
1476 | Lon: -1.54785
1477 |
1478 | #### Locations
1479 | Facility: John Radcliffe Hospital
1480 | City: Headington, Oxford
1481 | Zip: OX3 9DU
1482 | Country: United Kingdom
1483 |
1484 | ### References Module
1485 |
1486 | #### References
1487 | Pmid: 34473343
1488 | Type: DERIVED
1489 | Citation:
1490 | Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M,
1491 | Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C,
1492 | Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N.
1493 | SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19.
1494 | Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi:
1495 | 10.1002/14651858.CD013825.pub2.
1496 |
1497 | #### References
1498 | Pmid: 34350582
1499 | Type: DERIVED
1500 | Citation:
1501 | Ansems K, Grundeis F, Dahms K, Mikolajewska A, Thieme V, Piechotta V,
1502 | Metzendorf MI, Stegemann M, Benstoem C, Fichtner F. Remdesivir for the
1503 | treatment of COVID-19. Cochrane Database Syst Rev. 2021 Aug
1504 | 5;8(8):CD014962. doi: 10.1002/14651858.CD014962.
1505 |
1506 | #### References
1507 | Pmid: 33240091
1508 | Type: DERIVED
1509 | Citation:
1510 | Sultana J, Crisafulli S, Gabbay F, Lynn E, Shakir S, Trifiro G.
1511 | Challenges for Drug Repurposing in the COVID-19 Pandemic Era. Front
1512 | Pharmacol. 2020 Nov 6;11:588654. doi: 10.3389/fphar.2020.588654.
1513 | eCollection 2020.
1514 |
1515 | #### References
1516 | Pmid: 32969710
1517 | Type: DERIVED
1518 | Citation:
1519 | Maleszewski JJ, Young PM, Ackerman MJ, Halushka MK. Urgent Need for
1520 | Studies of the Late Effects of SARS-CoV-2 on the Cardiovascular System.
1521 | Circulation. 2021 Mar 30;143(13):1271-1273. doi:
1522 | 10.1161/CIRCULATIONAHA.120.051362. Epub 2020 Sep 24. No abstract
1523 | available.
1524 |
1525 | #### References
1526 | Pmid: 32445440
1527 | Type: DERIVED
1528 | Citation:
1529 | Beigel JH, Tomashek KM, Dodd LE, Mehta AK, Zingman BS, Kalil AC, Hohmann
1530 | E, Chu HY, Luetkemeyer A, Kline S, Lopez de Castilla D, Finberg RW,
1531 | Dierberg K, Tapson V, Hsieh L, Patterson TF, Paredes R, Sweeney DA,
1532 | Short WR, Touloumi G, Lye DC, Ohmagari N, Oh MD, Ruiz-Palacios GM,
1533 | Benfield T, Fatkenheuer G, Kortepeter MG, Atmar RL, Creech CB, Lundgren
1534 | J, Babiker AG, Pett S, Neaton JD, Burgess TH, Bonnett T, Green M,
1535 | Makowski M, Osinusi A, Nayak S, Lane HC; ACTT-1 Study Group Members.
1536 | Remdesivir for the Treatment of Covid-19 - Final Report. N Engl J Med.
1537 | 2020 Nov 5;383(19):1813-1826. doi: 10.1056/NEJMoa2007764. Epub 2020 Oct
1538 | 8.
1539 |
1540 | ## Results Section
1541 |
1542 | ### Participant Flow Module
1543 | Recruitment Details:
1544 | Participants were recruited at the participating sites from those
1545 | admitted with symptoms of COVID-19 confirmed by PCR. Enrollment occurred
1546 | between 21FEB2020 and 20APR2020.
1547 |
1548 | #### Groups
1549 | Id: FG000
1550 | Title: Placebo
1551 | Description:
1552 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
1553 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
1554 | while hospitalized for up to a 10 days total course.
1555 |
1556 | Placebo: The supplied placebo lyophilized formulation is identical in
1557 | physical appearance to the active lyophilized formulation and contains
1558 | the same inactive ingredients. Alternatively, a placebo of normal saline
1559 | of equal volume may be given if there are limitations on matching
1560 | placebo supplies.
1561 |
1562 | #### Groups
1563 | Id: FG001
1564 | Title: Remdesivir
1565 | Description:
1566 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
1567 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
1568 | up to a 10 days total course.
1569 |
1570 | Remdesivir: Drug Remdesivir is a single diastereomer monophosphoramidate
1571 | prodrug designed for the intracellular delivery of a modified adenine
1572 | nucleoside analog GS-441524. In addition to the active ingredient, the
1573 | lyophilized formulation of Remdesivir contains the following inactive
1574 | ingredients: water for injection, sulfobutylether beta-cyclodextrin
1575 | sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.
1576 |
1577 | #### Periods
1578 | Title: Overall Study
1579 |
1580 | ##### Milestones
1581 | Type: STARTED
1582 |
1583 | ##### Achievements
1584 | Group Id: FG000
1585 | Num Subjects: 521
1586 |
1587 | ##### Achievements
1588 | Group Id: FG001
1589 | Num Subjects: 541
1590 |
1591 | ##### Milestones
1592 | Type: Received Treatment
1593 |
1594 | ##### Achievements
1595 | Group Id: FG000
1596 | Num Subjects: 517
1597 |
1598 | ##### Achievements
1599 | Group Id: FG001
1600 | Num Subjects: 531
1601 |
1602 | ##### Milestones
1603 | Type: COMPLETED
1604 |
1605 | ##### Achievements
1606 | Group Id: FG000
1607 | Num Subjects: 508
1608 |
1609 | ##### Achievements
1610 | Group Id: FG001
1611 | Num Subjects: 517
1612 |
1613 | ##### Milestones
1614 | Type: NOT COMPLETED
1615 |
1616 | ##### Achievements
1617 | Group Id: FG000
1618 | Num Subjects: 13
1619 |
1620 | ##### Achievements
1621 | Group Id: FG001
1622 | Num Subjects: 24
1623 |
1624 | ##### Drop Withdraws
1625 | Type: Enrolled but not treated
1626 |
1627 | ##### Reasons
1628 | Group Id: FG000
1629 | Num Subjects: 4
1630 |
1631 | ##### Reasons
1632 | Group Id: FG001
1633 | Num Subjects: 10
1634 |
1635 | ##### Drop Withdraws
1636 | Type: Physician Decision
1637 |
1638 | ##### Reasons
1639 | Group Id: FG000
1640 | Num Subjects: 1
1641 |
1642 | ##### Reasons
1643 | Group Id: FG001
1644 | Num Subjects: 0
1645 |
1646 | ##### Drop Withdraws
1647 | Type: Withdrawal by Subject
1648 |
1649 | ##### Reasons
1650 | Group Id: FG000
1651 | Num Subjects: 7
1652 |
1653 | ##### Reasons
1654 | Group Id: FG001
1655 | Num Subjects: 9
1656 |
1657 | ##### Drop Withdraws
1658 | Type: Adverse Event
1659 |
1660 | ##### Reasons
1661 | Group Id: FG000
1662 | Num Subjects: 0
1663 |
1664 | ##### Reasons
1665 | Group Id: FG001
1666 | Num Subjects: 4
1667 |
1668 | ##### Drop Withdraws
1669 | Type: Transferred to another hospital
1670 |
1671 | ##### Reasons
1672 | Group Id: FG000
1673 | Num Subjects: 1
1674 |
1675 | ##### Reasons
1676 | Group Id: FG001
1677 | Num Subjects: 1
1678 |
1679 | ### Baseline Characteristics Module
1680 |
1681 | #### Groups
1682 | Id: BG000
1683 | Title: Placebo
1684 | Description:
1685 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
1686 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
1687 | while hospitalized for up to a 10 days total course.
1688 |
1689 | #### Groups
1690 | Id: BG001
1691 | Title: Remdesivir
1692 | Description:
1693 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
1694 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
1695 | up to a 10 days total course.
1696 |
1697 | #### Groups
1698 | Id: BG002
1699 | Title: Total
1700 | Description: Total of all reporting groups
1701 |
1702 | #### Denoms
1703 | Units: Participants
1704 |
1705 | ##### Counts
1706 | Group Id: BG000
1707 | Value: 521
1708 |
1709 | ##### Counts
1710 | Group Id: BG001
1711 | Value: 541
1712 |
1713 | ##### Counts
1714 | Group Id: BG002
1715 | Value: 1062
1716 |
1717 | #### Measures
1718 | Title: Age, Categorical
1719 | Param Type: COUNT_OF_PARTICIPANTS
1720 | Unit Of Measure: Participants
1721 |
1722 | ##### Classes
1723 |
1724 | ##### Categories
1725 | Title: <=18 years
1726 |
1727 | ##### Measurements
1728 | Group Id: BG000
1729 | Value: 0
1730 |
1731 | ##### Measurements
1732 | Group Id: BG001
1733 | Value: 0
1734 |
1735 | ##### Measurements
1736 | Group Id: BG002
1737 | Value: 0
1738 |
1739 | ##### Categories
1740 | Title: Between 18 and 65 years
1741 |
1742 | ##### Measurements
1743 | Group Id: BG000
1744 | Value: 324
1745 |
1746 | ##### Measurements
1747 | Group Id: BG001
1748 | Value: 354
1749 |
1750 | ##### Measurements
1751 | Group Id: BG002
1752 | Value: 678
1753 |
1754 | ##### Categories
1755 | Title: >=65 years
1756 |
1757 | ##### Measurements
1758 | Group Id: BG000
1759 | Value: 197
1760 |
1761 | ##### Measurements
1762 | Group Id: BG001
1763 | Value: 187
1764 |
1765 | ##### Measurements
1766 | Group Id: BG002
1767 | Value: 384
1768 |
1769 | #### Measures
1770 | Title: Age, Continuous
1771 | Param Type: MEAN
1772 | Dispersion Type: STANDARD_DEVIATION
1773 | Unit Of Measure: years
1774 |
1775 | ##### Classes
1776 |
1777 | ##### Categories
1778 |
1779 | ##### Measurements
1780 | Group Id: BG000
1781 | Value: 59.2
1782 | Spread: 15.4
1783 |
1784 | ##### Measurements
1785 | Group Id: BG001
1786 | Value: 58.6
1787 | Spread: 14.6
1788 |
1789 | ##### Measurements
1790 | Group Id: BG002
1791 | Value: 58.9
1792 | Spread: 15.0
1793 |
1794 | #### Measures
1795 | Title: Sex: Female, Male
1796 | Param Type: COUNT_OF_PARTICIPANTS
1797 | Unit Of Measure: Participants
1798 |
1799 | ##### Classes
1800 |
1801 | ##### Categories
1802 | Title: Female
1803 |
1804 | ##### Measurements
1805 | Group Id: BG000
1806 | Value: 189
1807 |
1808 | ##### Measurements
1809 | Group Id: BG001
1810 | Value: 189
1811 |
1812 | ##### Measurements
1813 | Group Id: BG002
1814 | Value: 378
1815 |
1816 | ##### Categories
1817 | Title: Male
1818 |
1819 | ##### Measurements
1820 | Group Id: BG000
1821 | Value: 332
1822 |
1823 | ##### Measurements
1824 | Group Id: BG001
1825 | Value: 352
1826 |
1827 | ##### Measurements
1828 | Group Id: BG002
1829 | Value: 684
1830 |
1831 | #### Measures
1832 | Title: Ethnicity (NIH/OMB)
1833 | Param Type: COUNT_OF_PARTICIPANTS
1834 | Unit Of Measure: Participants
1835 |
1836 | ##### Classes
1837 |
1838 | ##### Categories
1839 | Title: Hispanic or Latino
1840 |
1841 | ##### Measurements
1842 | Group Id: BG000
1843 | Value: 116
1844 |
1845 | ##### Measurements
1846 | Group Id: BG001
1847 | Value: 134
1848 |
1849 | ##### Measurements
1850 | Group Id: BG002
1851 | Value: 250
1852 |
1853 | ##### Categories
1854 | Title: Not Hispanic or Latino
1855 |
1856 | ##### Measurements
1857 | Group Id: BG000
1858 | Value: 373
1859 |
1860 | ##### Measurements
1861 | Group Id: BG001
1862 | Value: 382
1863 |
1864 | ##### Measurements
1865 | Group Id: BG002
1866 | Value: 755
1867 |
1868 | ##### Categories
1869 | Title: Unknown or Not Reported
1870 |
1871 | ##### Measurements
1872 | Group Id: BG000
1873 | Value: 32
1874 |
1875 | ##### Measurements
1876 | Group Id: BG001
1877 | Value: 25
1878 |
1879 | ##### Measurements
1880 | Group Id: BG002
1881 | Value: 57
1882 |
1883 | #### Measures
1884 | Title: Race (NIH/OMB)
1885 | Param Type: COUNT_OF_PARTICIPANTS
1886 | Unit Of Measure: Participants
1887 |
1888 | ##### Classes
1889 |
1890 | ##### Categories
1891 | Title: American Indian or Alaska Native
1892 |
1893 | ##### Measurements
1894 | Group Id: BG000
1895 | Value: 3
1896 |
1897 | ##### Measurements
1898 | Group Id: BG001
1899 | Value: 4
1900 |
1901 | ##### Measurements
1902 | Group Id: BG002
1903 | Value: 7
1904 |
1905 | ##### Categories
1906 | Title: Asian
1907 |
1908 | ##### Measurements
1909 | Group Id: BG000
1910 | Value: 56
1911 |
1912 | ##### Measurements
1913 | Group Id: BG001
1914 | Value: 79
1915 |
1916 | ##### Measurements
1917 | Group Id: BG002
1918 | Value: 135
1919 |
1920 | ##### Categories
1921 | Title: Native Hawaiian or Other Pacific Islander
1922 |
1923 | ##### Measurements
1924 | Group Id: BG000
1925 | Value: 2
1926 |
1927 | ##### Measurements
1928 | Group Id: BG001
1929 | Value: 2
1930 |
1931 | ##### Measurements
1932 | Group Id: BG002
1933 | Value: 4
1934 |
1935 | ##### Categories
1936 | Title: Black or African American
1937 |
1938 | ##### Measurements
1939 | Group Id: BG000
1940 | Value: 117
1941 |
1942 | ##### Measurements
1943 | Group Id: BG001
1944 | Value: 109
1945 |
1946 | ##### Measurements
1947 | Group Id: BG002
1948 | Value: 226
1949 |
1950 | ##### Categories
1951 | Title: White
1952 |
1953 | ##### Measurements
1954 | Group Id: BG000
1955 | Value: 287
1956 |
1957 | ##### Measurements
1958 | Group Id: BG001
1959 | Value: 279
1960 |
1961 | ##### Measurements
1962 | Group Id: BG002
1963 | Value: 566
1964 |
1965 | ##### Categories
1966 | Title: More than one race
1967 |
1968 | ##### Measurements
1969 | Group Id: BG000
1970 | Value: 1
1971 |
1972 | ##### Measurements
1973 | Group Id: BG001
1974 | Value: 2
1975 |
1976 | ##### Measurements
1977 | Group Id: BG002
1978 | Value: 3
1979 |
1980 | ##### Categories
1981 | Title: Unknown or Not Reported
1982 |
1983 | ##### Measurements
1984 | Group Id: BG000
1985 | Value: 55
1986 |
1987 | ##### Measurements
1988 | Group Id: BG001
1989 | Value: 66
1990 |
1991 | ##### Measurements
1992 | Group Id: BG002
1993 | Value: 121
1994 |
1995 | #### Measures
1996 | Title: Region of Enrollment
1997 | Param Type: NUMBER
1998 | Unit Of Measure: participants
1999 |
2000 | ##### Classes
2001 | Title: Greece
2002 |
2003 | ##### Categories
2004 |
2005 | ##### Measurements
2006 | Group Id: BG000
2007 | Value: 19
2008 |
2009 | ##### Measurements
2010 | Group Id: BG001
2011 | Value: 14
2012 |
2013 | ##### Measurements
2014 | Group Id: BG002
2015 | Value: 33
2016 |
2017 | ##### Classes
2018 | Title: South Korea
2019 |
2020 | ##### Categories
2021 |
2022 | ##### Measurements
2023 | Group Id: BG000
2024 | Value: 12
2025 |
2026 | ##### Measurements
2027 | Group Id: BG001
2028 | Value: 9
2029 |
2030 | ##### Measurements
2031 | Group Id: BG002
2032 | Value: 21
2033 |
2034 | ##### Classes
2035 | Title: Singapore
2036 |
2037 | ##### Categories
2038 |
2039 | ##### Measurements
2040 | Group Id: BG000
2041 | Value: 7
2042 |
2043 | ##### Measurements
2044 | Group Id: BG001
2045 | Value: 9
2046 |
2047 | ##### Measurements
2048 | Group Id: BG002
2049 | Value: 16
2050 |
2051 | ##### Classes
2052 | Title: United States
2053 |
2054 | ##### Categories
2055 |
2056 | ##### Measurements
2057 | Group Id: BG000
2058 | Value: 410
2059 |
2060 | ##### Measurements
2061 | Group Id: BG001
2062 | Value: 427
2063 |
2064 | ##### Measurements
2065 | Group Id: BG002
2066 | Value: 837
2067 |
2068 | ##### Classes
2069 | Title: Japan
2070 |
2071 | ##### Categories
2072 |
2073 | ##### Measurements
2074 | Group Id: BG000
2075 | Value: 7
2076 |
2077 | ##### Measurements
2078 | Group Id: BG001
2079 | Value: 8
2080 |
2081 | ##### Measurements
2082 | Group Id: BG002
2083 | Value: 15
2084 |
2085 | ##### Classes
2086 | Title: Denmark
2087 |
2088 | ##### Categories
2089 |
2090 | ##### Measurements
2091 | Group Id: BG000
2092 | Value: 21
2093 |
2094 | ##### Measurements
2095 | Group Id: BG001
2096 | Value: 22
2097 |
2098 | ##### Measurements
2099 | Group Id: BG002
2100 | Value: 43
2101 |
2102 | ##### Classes
2103 | Title: Mexico
2104 |
2105 | ##### Categories
2106 |
2107 | ##### Measurements
2108 | Group Id: BG000
2109 | Value: 6
2110 |
2111 | ##### Measurements
2112 | Group Id: BG001
2113 | Value: 4
2114 |
2115 | ##### Measurements
2116 | Group Id: BG002
2117 | Value: 10
2118 |
2119 | ##### Classes
2120 | Title: United Kingdom
2121 |
2122 | ##### Categories
2123 |
2124 | ##### Measurements
2125 | Group Id: BG000
2126 | Value: 21
2127 |
2128 | ##### Measurements
2129 | Group Id: BG001
2130 | Value: 25
2131 |
2132 | ##### Measurements
2133 | Group Id: BG002
2134 | Value: 46
2135 |
2136 | ##### Classes
2137 | Title: Germany
2138 |
2139 | ##### Categories
2140 |
2141 | ##### Measurements
2142 | Group Id: BG000
2143 | Value: 6
2144 |
2145 | ##### Measurements
2146 | Group Id: BG001
2147 | Value: 7
2148 |
2149 | ##### Measurements
2150 | Group Id: BG002
2151 | Value: 13
2152 |
2153 | ##### Classes
2154 | Title: Spain
2155 |
2156 | ##### Categories
2157 |
2158 | ##### Measurements
2159 | Group Id: BG000
2160 | Value: 12
2161 |
2162 | ##### Measurements
2163 | Group Id: BG001
2164 | Value: 16
2165 |
2166 | ##### Measurements
2167 | Group Id: BG002
2168 | Value: 28
2169 |
2170 | #### Measures
2171 | Title: Disease severity
2172 | Description:
2173 | Mild-moderate disease: SpO2 \> 94% and respiratory rate \< 24
2174 | breaths/min without supplemental oxygen.
2175 |
2176 | Severe disease: requiring mechanical ventilation, requiring oxygen, a
2177 | SpO2 = 94% on room air, or tachypnea (respiratory rate = 24
2178 | breaths/min).
2179 | Param Type: COUNT_OF_PARTICIPANTS
2180 | Unit Of Measure: Participants
2181 |
2182 | ##### Classes
2183 | Title: Mild-to-moderate disease severity
2184 |
2185 | ##### Categories
2186 |
2187 | ##### Measurements
2188 | Group Id: BG000
2189 | Value: 50
2190 |
2191 | ##### Measurements
2192 | Group Id: BG001
2193 | Value: 55
2194 |
2195 | ##### Measurements
2196 | Group Id: BG002
2197 | Value: 105
2198 |
2199 | ##### Classes
2200 | Title: Severe disease severity
2201 |
2202 | ##### Categories
2203 |
2204 | ##### Measurements
2205 | Group Id: BG000
2206 | Value: 471
2207 |
2208 | ##### Measurements
2209 | Group Id: BG001
2210 | Value: 486
2211 |
2212 | ##### Measurements
2213 | Group Id: BG002
2214 | Value: 957
2215 |
2216 | ### Outcome Measures Module
2217 |
2218 | #### Outcome Measures
2219 | Type: PRIMARY
2220 | Title: Time to Recovery
2221 | Description:
2222 | Day of recovery is defined as the first day on which the subject
2223 | satisfies one of the following three categories from the ordinal scale:
2224 | 1) Hospitalized, not requiring supplemental oxygen - no longer requires
2225 | ongoing medical care; 2) Not hospitalized, limitation on activities
2226 | and/or requiring home oxygen; 3) Not hospitalized, no limitations on
2227 | activities.
2228 | Population Description:
2229 | The intent-to-treat (ITT) population includes all participants who were
2230 | randomized
2231 | Reporting Status: POSTED
2232 | Param Type: MEDIAN
2233 | Dispersion Type: 95% Confidence Interval
2234 | Unit Of Measure: Days
2235 | Time Frame: Day 1 through Day 29
2236 |
2237 | ##### Groups
2238 | Id: OG000
2239 | Title: Placebo
2240 | Description:
2241 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
2242 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
2243 | while hospitalized for up to a 10 days total course.
2244 |
2245 | ##### Groups
2246 | Id: OG001
2247 | Title: Remdesivir
2248 | Description:
2249 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
2250 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
2251 | up to a 10 days total course.
2252 |
2253 | ##### Denoms
2254 | Units: Participants
2255 |
2256 | ##### Counts
2257 | Group Id: OG000
2258 | Value: 521
2259 |
2260 | ##### Counts
2261 | Group Id: OG001
2262 | Value: 541
2263 |
2264 | ##### Classes
2265 |
2266 | ##### Categories
2267 |
2268 | ##### Measurements
2269 | Group Id: OG000
2270 | Value: 15
2271 | Lower Limit: 13
2272 | Upper Limit: 18
2273 |
2274 | ##### Measurements
2275 | Group Id: OG001
2276 | Value: 10
2277 | Lower Limit: 9
2278 | Upper Limit: 11
2279 |
2280 | ##### Analyses
2281 | Non Inferiority Type: SUPERIORITY
2282 | P Value: <0.001
2283 | Statistical Method: Log Rank
2284 | Param Type: Cox Proportional Hazard
2285 | Param Value: 1.29
2286 | Ci Pct Value: 95
2287 | Ci Num Sides: TWO_SIDED
2288 | Ci Lower Limit: 1.12
2289 | Ci Upper Limit: 1.49
2290 | Group Ids: OG000, OG001
2291 |
2292 | #### Outcome Measures
2293 | Type: SECONDARY
2294 | Title: Change From Baseline in Alanine Transaminase (ALT)
2295 | Description:
2296 | Blood to evaluate ALT was collected at Days 1, 3, 5, 8, and 11 while
2297 | participants were inpatient, and at Days 15 and 29, with the Day 1
2298 | assessment serving as baseline. Participants who had been discharged had
2299 | blood collected if infection control measures allowed for in-person
2300 | visits after discharge.
2301 | Population Description:
2302 | The safety population includes all treated participants with available
2303 | data at baseline and the post baseline assessment point, analyzed as
2304 | treated.
2305 | Reporting Status: POSTED
2306 | Param Type: MEAN
2307 | Dispersion Type: Standard Deviation
2308 | Unit Of Measure: Units/Liter (U/L)
2309 | Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
2310 |
2311 | ##### Groups
2312 | Id: OG000
2313 | Title: Placebo
2314 | Description:
2315 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
2316 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
2317 | while hospitalized for up to a 10 days total course.
2318 |
2319 | ##### Groups
2320 | Id: OG001
2321 | Title: Remdesivir
2322 | Description:
2323 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
2324 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
2325 | up to a 10 days total course.
2326 |
2327 | ##### Denoms
2328 | Units: Participants
2329 |
2330 | ##### Counts
2331 | Group Id: OG000
2332 | Value: 463
2333 |
2334 | ##### Counts
2335 | Group Id: OG001
2336 | Value: 465
2337 |
2338 | ##### Classes
2339 | Title: Day 3
2340 |
2341 | ##### Denoms
2342 | Units: Participants
2343 |
2344 | ##### Counts
2345 | Group Id: OG000
2346 | Value: 463
2347 |
2348 | ##### Counts
2349 | Group Id: OG001
2350 | Value: 465
2351 |
2352 | ##### Categories
2353 |
2354 | ##### Measurements
2355 | Group Id: OG000
2356 | Value: 14.3
2357 | Spread: 88
2358 |
2359 | ##### Measurements
2360 | Group Id: OG001
2361 | Value: 2.9
2362 | Spread: 31.5
2363 |
2364 | ##### Classes
2365 | Title: Day 5
2366 |
2367 | ##### Denoms
2368 | Units: Participants
2369 |
2370 | ##### Counts
2371 | Group Id: OG000
2372 | Value: 403
2373 |
2374 | ##### Counts
2375 | Group Id: OG001
2376 | Value: 398
2377 |
2378 | ##### Categories
2379 |
2380 | ##### Measurements
2381 | Group Id: OG000
2382 | Value: 23.1
2383 | Spread: 70.6
2384 |
2385 | ##### Measurements
2386 | Group Id: OG001
2387 | Value: 10.8
2388 | Spread: 55.8
2389 |
2390 | ##### Classes
2391 | Title: Day 8
2392 |
2393 | ##### Denoms
2394 | Units: Participants
2395 |
2396 | ##### Counts
2397 | Group Id: OG000
2398 | Value: 327
2399 |
2400 | ##### Counts
2401 | Group Id: OG001
2402 | Value: 296
2403 |
2404 | ##### Categories
2405 |
2406 | ##### Measurements
2407 | Group Id: OG000
2408 | Value: 24.2
2409 | Spread: 79.7
2410 |
2411 | ##### Measurements
2412 | Group Id: OG001
2413 | Value: 8.9
2414 | Spread: 54.2
2415 |
2416 | ##### Classes
2417 | Title: Day 11
2418 |
2419 | ##### Denoms
2420 | Units: Participants
2421 |
2422 | ##### Counts
2423 | Group Id: OG000
2424 | Value: 257
2425 |
2426 | ##### Counts
2427 | Group Id: OG001
2428 | Value: 227
2429 |
2430 | ##### Categories
2431 |
2432 | ##### Measurements
2433 | Group Id: OG000
2434 | Value: 27.7
2435 | Spread: 89.8
2436 |
2437 | ##### Measurements
2438 | Group Id: OG001
2439 | Value: 3.4
2440 | Spread: 48.4
2441 |
2442 | ##### Classes
2443 | Title: Day 15
2444 |
2445 | ##### Denoms
2446 | Units: Participants
2447 |
2448 | ##### Counts
2449 | Group Id: OG000
2450 | Value: 242
2451 |
2452 | ##### Counts
2453 | Group Id: OG001
2454 | Value: 257
2455 |
2456 | ##### Categories
2457 |
2458 | ##### Measurements
2459 | Group Id: OG000
2460 | Value: 28.1
2461 | Spread: 110.1
2462 |
2463 | ##### Measurements
2464 | Group Id: OG001
2465 | Value: 1.7
2466 | Spread: 47.4
2467 |
2468 | ##### Classes
2469 | Title: Day 29
2470 |
2471 | ##### Denoms
2472 | Units: Participants
2473 |
2474 | ##### Counts
2475 | Group Id: OG000
2476 | Value: 180
2477 |
2478 | ##### Counts
2479 | Group Id: OG001
2480 | Value: 220
2481 |
2482 | ##### Categories
2483 |
2484 | ##### Measurements
2485 | Group Id: OG000
2486 | Value: -3.9
2487 | Spread: 62.2
2488 |
2489 | ##### Measurements
2490 | Group Id: OG001
2491 | Value: -6.8
2492 | Spread: 43.7
2493 |
2494 | #### Outcome Measures
2495 | Type: SECONDARY
2496 | Title: Change From Baseline in Aspartate Transaminase (AST)
2497 | Description:
2498 | Blood to evaluate AST was collected at Days 1, 3, 5, 8, and 11 while
2499 | participants were inpatient, and at Days 15 and 29, with the Day 1
2500 | assessment serving as baseline. Participants who had been discharged had
2501 | blood collected if infection control measures allowed for in-person
2502 | visits after discharge.
2503 | Population Description:
2504 | The safety population includes all treated participants with available
2505 | data at baseline and the post baseline assessment point, analyzed as
2506 | treated.
2507 | Reporting Status: POSTED
2508 | Param Type: MEAN
2509 | Dispersion Type: Standard Deviation
2510 | Unit Of Measure: Units/Liter (U/L)
2511 | Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
2512 |
2513 | ##### Groups
2514 | Id: OG000
2515 | Title: Placebo
2516 | Description:
2517 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
2518 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
2519 | while hospitalized for up to a 10 days total course.
2520 |
2521 | ##### Groups
2522 | Id: OG001
2523 | Title: Remdesivir
2524 | Description:
2525 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
2526 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
2527 | up to a 10 days total course.
2528 |
2529 | ##### Denoms
2530 | Units: Participants
2531 |
2532 | ##### Counts
2533 | Group Id: OG000
2534 | Value: 438
2535 |
2536 | ##### Counts
2537 | Group Id: OG001
2538 | Value: 445
2539 |
2540 | ##### Classes
2541 | Title: Day 3
2542 |
2543 | ##### Denoms
2544 | Units: Participants
2545 |
2546 | ##### Counts
2547 | Group Id: OG000
2548 | Value: 438
2549 |
2550 | ##### Counts
2551 | Group Id: OG001
2552 | Value: 445
2553 |
2554 | ##### Categories
2555 |
2556 | ##### Measurements
2557 | Group Id: OG000
2558 | Value: 13.7
2559 | Spread: 90.7
2560 |
2561 | ##### Measurements
2562 | Group Id: OG001
2563 | Value: -2.0
2564 | Spread: 29.1
2565 |
2566 | ##### Classes
2567 | Title: Day 5
2568 |
2569 | ##### Denoms
2570 | Units: Participants
2571 |
2572 | ##### Counts
2573 | Group Id: OG000
2574 | Value: 384
2575 |
2576 | ##### Counts
2577 | Group Id: OG001
2578 | Value: 380
2579 |
2580 | ##### Categories
2581 |
2582 | ##### Measurements
2583 | Group Id: OG000
2584 | Value: 12.8
2585 | Spread: 66.2
2586 |
2587 | ##### Measurements
2588 | Group Id: OG001
2589 | Value: 6.0
2590 | Spread: 58.9
2591 |
2592 | ##### Classes
2593 | Title: Day 8
2594 |
2595 | ##### Denoms
2596 | Units: Participants
2597 |
2598 | ##### Counts
2599 | Group Id: OG000
2600 | Value: 315
2601 |
2602 | ##### Counts
2603 | Group Id: OG001
2604 | Value: 285
2605 |
2606 | ##### Categories
2607 |
2608 | ##### Measurements
2609 | Group Id: OG000
2610 | Value: 13.1
2611 | Spread: 114.6
2612 |
2613 | ##### Measurements
2614 | Group Id: OG001
2615 | Value: 1.1
2616 | Spread: 55.9
2617 |
2618 | ##### Classes
2619 | Title: Day 11
2620 |
2621 | ##### Denoms
2622 | Units: Participants
2623 |
2624 | ##### Counts
2625 | Group Id: OG000
2626 | Value: 247
2627 |
2628 | ##### Counts
2629 | Group Id: OG001
2630 | Value: 219
2631 |
2632 | ##### Categories
2633 |
2634 | ##### Measurements
2635 | Group Id: OG000
2636 | Value: 11.5
2637 | Spread: 78.8
2638 |
2639 | ##### Measurements
2640 | Group Id: OG001
2641 | Value: -0.3
2642 | Spread: 51.7
2643 |
2644 | ##### Classes
2645 | Title: Day 15
2646 |
2647 | ##### Denoms
2648 | Units: Participants
2649 |
2650 | ##### Counts
2651 | Group Id: OG000
2652 | Value: 236
2653 |
2654 | ##### Counts
2655 | Group Id: OG001
2656 | Value: 248
2657 |
2658 | ##### Categories
2659 |
2660 | ##### Measurements
2661 | Group Id: OG000
2662 | Value: 4.2
2663 | Spread: 73.0
2664 |
2665 | ##### Measurements
2666 | Group Id: OG001
2667 | Value: -2.3
2668 | Spread: 60.4
2669 |
2670 | ##### Classes
2671 | Title: Day 29
2672 |
2673 | ##### Denoms
2674 | Units: Participants
2675 |
2676 | ##### Counts
2677 | Group Id: OG000
2678 | Value: 170
2679 |
2680 | ##### Counts
2681 | Group Id: OG001
2682 | Value: 208
2683 |
2684 | ##### Categories
2685 |
2686 | ##### Measurements
2687 | Group Id: OG000
2688 | Value: -18.4
2689 | Spread: 47.2
2690 |
2691 | ##### Measurements
2692 | Group Id: OG001
2693 | Value: -14.0
2694 | Spread: 52.2
2695 |
2696 | #### Outcome Measures
2697 | Type: SECONDARY
2698 | Title: Change From Baseline in Creatinine
2699 | Description:
2700 | Blood to evaluate serum creatinine was collected at Days 1, 3, 5, 8, and
2701 | 11 while participants were inpatient, and at Days 15 and 29, with the
2702 | Day 1 assessment serving as baseline. Participants who had been
2703 | discharged had blood collected if infection control measures allowed for
2704 | in-person visits after discharge.
2705 | Population Description:
2706 | The safety population includes all treated participants with available
2707 | data at baseline and the post baseline assessment point, analyzed as
2708 | treated.
2709 | Reporting Status: POSTED
2710 | Param Type: MEAN
2711 | Dispersion Type: Standard Deviation
2712 | Unit Of Measure: milligrams/deciliter (mg/dL)
2713 | Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
2714 |
2715 | ##### Groups
2716 | Id: OG000
2717 | Title: Placebo
2718 | Description:
2719 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
2720 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
2721 | while hospitalized for up to a 10 days total course.
2722 |
2723 | ##### Groups
2724 | Id: OG001
2725 | Title: Remdesivir
2726 | Description:
2727 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
2728 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
2729 | up to a 10 days total course.
2730 |
2731 | ##### Denoms
2732 | Units: Participants
2733 |
2734 | ##### Counts
2735 | Group Id: OG000
2736 | Value: 475
2737 |
2738 | ##### Counts
2739 | Group Id: OG001
2740 | Value: 482
2741 |
2742 | ##### Classes
2743 | Title: Day 3
2744 |
2745 | ##### Denoms
2746 | Units: Participants
2747 |
2748 | ##### Counts
2749 | Group Id: OG000
2750 | Value: 475
2751 |
2752 | ##### Counts
2753 | Group Id: OG001
2754 | Value: 482
2755 |
2756 | ##### Categories
2757 |
2758 | ##### Measurements
2759 | Group Id: OG000
2760 | Value: 0.037
2761 | Spread: 0.517
2762 |
2763 | ##### Measurements
2764 | Group Id: OG001
2765 | Value: 0.038
2766 | Spread: 0.569
2767 |
2768 | ##### Classes
2769 | Title: Day 5
2770 |
2771 | ##### Denoms
2772 | Units: Participants
2773 |
2774 | ##### Counts
2775 | Group Id: OG000
2776 | Value: 418
2777 |
2778 | ##### Counts
2779 | Group Id: OG001
2780 | Value: 411
2781 |
2782 | ##### Categories
2783 |
2784 | ##### Measurements
2785 | Group Id: OG000
2786 | Value: -0.695
2787 | Spread: 17.552
2788 |
2789 | ##### Measurements
2790 | Group Id: OG001
2791 | Value: 0.075
2792 | Spread: 0.762
2793 |
2794 | ##### Classes
2795 | Title: Day 8
2796 |
2797 | ##### Denoms
2798 | Units: Participants
2799 |
2800 | ##### Counts
2801 | Group Id: OG000
2802 | Value: 335
2803 |
2804 | ##### Counts
2805 | Group Id: OG001
2806 | Value: 309
2807 |
2808 | ##### Categories
2809 |
2810 | ##### Measurements
2811 | Group Id: OG000
2812 | Value: -0.882
2813 | Spread: 19.637
2814 |
2815 | ##### Measurements
2816 | Group Id: OG001
2817 | Value: 0.158
2818 | Spread: 0.951
2819 |
2820 | ##### Classes
2821 | Title: Day 11
2822 |
2823 | ##### Denoms
2824 | Units: Participants
2825 |
2826 | ##### Counts
2827 | Group Id: OG000
2828 | Value: 269
2829 |
2830 | ##### Counts
2831 | Group Id: OG001
2832 | Value: 234
2833 |
2834 | ##### Categories
2835 |
2836 | ##### Measurements
2837 | Group Id: OG000
2838 | Value: 1.173
2839 | Spread: 15.440
2840 |
2841 | ##### Measurements
2842 | Group Id: OG001
2843 | Value: 0.236
2844 | Spread: 1.057
2845 |
2846 | ##### Classes
2847 | Title: Day 15
2848 |
2849 | ##### Denoms
2850 | Units: Participants
2851 |
2852 | ##### Counts
2853 | Group Id: OG000
2854 | Value: 249
2855 |
2856 | ##### Counts
2857 | Group Id: OG001
2858 | Value: 262
2859 |
2860 | ##### Categories
2861 |
2862 | ##### Measurements
2863 | Group Id: OG000
2864 | Value: -1.239
2865 | Spread: 22.755
2866 |
2867 | ##### Measurements
2868 | Group Id: OG001
2869 | Value: 0.319
2870 | Spread: 2.147
2871 |
2872 | ##### Classes
2873 | Title: Day 29
2874 |
2875 | ##### Denoms
2876 | Units: Participants
2877 |
2878 | ##### Counts
2879 | Group Id: OG000
2880 | Value: 189
2881 |
2882 | ##### Counts
2883 | Group Id: OG001
2884 | Value: 229
2885 |
2886 | ##### Categories
2887 |
2888 | ##### Measurements
2889 | Group Id: OG000
2890 | Value: -1.863
2891 | Spread: 26.093
2892 |
2893 | ##### Measurements
2894 | Group Id: OG001
2895 | Value: 0.075
2896 | Spread: 0.644
2897 |
2898 | #### Outcome Measures
2899 | Type: SECONDARY
2900 | Title: Change From Baseline in Glucose
2901 | Description:
2902 | Blood to evaluate serum glucose was collected at Days 1, 3, 5, 8, and 11
2903 | while participants were inpatient, and at Days 15 and 29, with the Day 1
2904 | assessment serving as baseline. Participants who had been discharged had
2905 | blood collected if infection control measures allowed for in-person
2906 | visits after discharge.
2907 | Population Description:
2908 | The safety population includes all treated participants with available
2909 | data at baseline and the post baseline assessment point, analyzed as
2910 | treated.
2911 | Reporting Status: POSTED
2912 | Param Type: MEAN
2913 | Dispersion Type: Standard Deviation
2914 | Unit Of Measure: mg/dL
2915 | Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
2916 |
2917 | ##### Groups
2918 | Id: OG000
2919 | Title: Placebo
2920 | Description:
2921 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
2922 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
2923 | while hospitalized for up to a 10 days total course.
2924 |
2925 | ##### Groups
2926 | Id: OG001
2927 | Title: Remdesivir
2928 | Description:
2929 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
2930 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
2931 | up to a 10 days total course.
2932 |
2933 | ##### Denoms
2934 | Units: Participants
2935 |
2936 | ##### Counts
2937 | Group Id: OG000
2938 | Value: 456
2939 |
2940 | ##### Counts
2941 | Group Id: OG001
2942 | Value: 459
2943 |
2944 | ##### Classes
2945 | Title: Day 3
2946 |
2947 | ##### Denoms
2948 | Units: Participants
2949 |
2950 | ##### Counts
2951 | Group Id: OG000
2952 | Value: 456
2953 |
2954 | ##### Counts
2955 | Group Id: OG001
2956 | Value: 459
2957 |
2958 | ##### Categories
2959 |
2960 | ##### Measurements
2961 | Group Id: OG000
2962 | Value: -0.2
2963 | Spread: 53.4
2964 |
2965 | ##### Measurements
2966 | Group Id: OG001
2967 | Value: -3.0
2968 | Spread: 49.4
2969 |
2970 | ##### Classes
2971 | Title: Day 5
2972 |
2973 | ##### Denoms
2974 | Units: Participants
2975 |
2976 | ##### Counts
2977 | Group Id: OG000
2978 | Value: 407
2979 |
2980 | ##### Counts
2981 | Group Id: OG001
2982 | Value: 395
2983 |
2984 | ##### Categories
2985 |
2986 | ##### Measurements
2987 | Group Id: OG000
2988 | Value: 6.3
2989 | Spread: 60.2
2990 |
2991 | ##### Measurements
2992 | Group Id: OG001
2993 | Value: 2.1
2994 | Spread: 63.8
2995 |
2996 | ##### Classes
2997 | Title: Day 8
2998 |
2999 | ##### Denoms
3000 | Units: Participants
3001 |
3002 | ##### Counts
3003 | Group Id: OG000
3004 | Value: 323
3005 |
3006 | ##### Counts
3007 | Group Id: OG001
3008 | Value: 301
3009 |
3010 | ##### Categories
3011 |
3012 | ##### Measurements
3013 | Group Id: OG000
3014 | Value: 2.2
3015 | Spread: 73.3
3016 |
3017 | ##### Measurements
3018 | Group Id: OG001
3019 | Value: 3.2
3020 | Spread: 68.0
3021 |
3022 | ##### Classes
3023 | Title: Day 11
3024 |
3025 | ##### Denoms
3026 | Units: Participants
3027 |
3028 | ##### Counts
3029 | Group Id: OG000
3030 | Value: 260
3031 |
3032 | ##### Counts
3033 | Group Id: OG001
3034 | Value: 228
3035 |
3036 | ##### Categories
3037 |
3038 | ##### Measurements
3039 | Group Id: OG000
3040 | Value: 1.0
3041 | Spread: 70.1
3042 |
3043 | ##### Measurements
3044 | Group Id: OG001
3045 | Value: -0.1
3046 | Spread: 77.4
3047 |
3048 | ##### Classes
3049 | Title: Day 15
3050 |
3051 | ##### Denoms
3052 | Units: Participants
3053 |
3054 | ##### Counts
3055 | Group Id: OG000
3056 | Value: 241
3057 |
3058 | ##### Counts
3059 | Group Id: OG001
3060 | Value: 250
3061 |
3062 | ##### Categories
3063 |
3064 | ##### Measurements
3065 | Group Id: OG000
3066 | Value: -2.8
3067 | Spread: 64.4
3068 |
3069 | ##### Measurements
3070 | Group Id: OG001
3071 | Value: -2.9
3072 | Spread: 75.4
3073 |
3074 | ##### Classes
3075 | Title: Day 29
3076 |
3077 | ##### Denoms
3078 | Units: Participants
3079 |
3080 | ##### Counts
3081 | Group Id: OG000
3082 | Value: 180
3083 |
3084 | ##### Counts
3085 | Group Id: OG001
3086 | Value: 219
3087 |
3088 | ##### Categories
3089 |
3090 | ##### Measurements
3091 | Group Id: OG000
3092 | Value: -13.5
3093 | Spread: 96.8
3094 |
3095 | ##### Measurements
3096 | Group Id: OG001
3097 | Value: -11.7
3098 | Spread: 75.4
3099 |
3100 | #### Outcome Measures
3101 | Type: SECONDARY
3102 | Title: Change From Baseline in Hemoglobin
3103 | Description:
3104 | Blood to evaluate hemoglobin was collected at Days 1, 3, 5, 8, and 11
3105 | while participants were inpatient, and at Days 15 and 29, with the Day 1
3106 | assessment serving as baseline. Participants who had been discharged had
3107 | blood collected if infection control measures allowed for in-person
3108 | visits after discharge.
3109 | Population Description:
3110 | The safety population includes all treated participants with available
3111 | data at baseline and the post baseline assessment point, analyzed as
3112 | treated.
3113 | Reporting Status: POSTED
3114 | Param Type: MEAN
3115 | Dispersion Type: Standard Deviation
3116 | Unit Of Measure: grams/deciliter (g/dL)
3117 | Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
3118 |
3119 | ##### Groups
3120 | Id: OG000
3121 | Title: Placebo
3122 | Description:
3123 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
3124 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
3125 | while hospitalized for up to a 10 days total course.
3126 |
3127 | ##### Groups
3128 | Id: OG001
3129 | Title: Remdesivir
3130 | Description:
3131 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
3132 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
3133 | up to a 10 days total course.
3134 |
3135 | ##### Denoms
3136 | Units: Participants
3137 |
3138 | ##### Counts
3139 | Group Id: OG000
3140 | Value: 475
3141 |
3142 | ##### Counts
3143 | Group Id: OG001
3144 | Value: 475
3145 |
3146 | ##### Classes
3147 | Title: Day 3
3148 |
3149 | ##### Denoms
3150 | Units: Participants
3151 |
3152 | ##### Counts
3153 | Group Id: OG000
3154 | Value: 475
3155 |
3156 | ##### Counts
3157 | Group Id: OG001
3158 | Value: 475
3159 |
3160 | ##### Categories
3161 |
3162 | ##### Measurements
3163 | Group Id: OG000
3164 | Value: -0.52
3165 | Spread: 1.10
3166 |
3167 | ##### Measurements
3168 | Group Id: OG001
3169 | Value: -0.69
3170 | Spread: 5.36
3171 |
3172 | ##### Classes
3173 | Title: Day 5
3174 |
3175 | ##### Denoms
3176 | Units: Participants
3177 |
3178 | ##### Counts
3179 | Group Id: OG000
3180 | Value: 420
3181 |
3182 | ##### Counts
3183 | Group Id: OG001
3184 | Value: 406
3185 |
3186 | ##### Categories
3187 |
3188 | ##### Measurements
3189 | Group Id: OG000
3190 | Value: -0.83
3191 | Spread: 1.22
3192 |
3193 | ##### Measurements
3194 | Group Id: OG001
3195 | Value: -0.99
3196 | Spread: 5.83
3197 |
3198 | ##### Classes
3199 | Title: Day 8
3200 |
3201 | ##### Denoms
3202 | Units: Participants
3203 |
3204 | ##### Counts
3205 | Group Id: OG000
3206 | Value: 334
3207 |
3208 | ##### Counts
3209 | Group Id: OG001
3210 | Value: 310
3211 |
3212 | ##### Categories
3213 |
3214 | ##### Measurements
3215 | Group Id: OG000
3216 | Value: -1.22
3217 | Spread: 1.42
3218 |
3219 | ##### Measurements
3220 | Group Id: OG001
3221 | Value: -0.49
3222 | Spread: 6.54
3223 |
3224 | ##### Classes
3225 | Title: Day 11
3226 |
3227 | ##### Denoms
3228 | Units: Participants
3229 |
3230 | ##### Counts
3231 | Group Id: OG000
3232 | Value: 269
3233 |
3234 | ##### Counts
3235 | Group Id: OG001
3236 | Value: 230
3237 |
3238 | ##### Categories
3239 |
3240 | ##### Measurements
3241 | Group Id: OG000
3242 | Value: -1.66
3243 | Spread: 1.67
3244 |
3245 | ##### Measurements
3246 | Group Id: OG001
3247 | Value: -1.29
3248 | Spread: 1.93
3249 |
3250 | ##### Classes
3251 | Title: Day 15
3252 |
3253 | ##### Denoms
3254 | Units: Participants
3255 |
3256 | ##### Counts
3257 | Group Id: OG000
3258 | Value: 253
3259 |
3260 | ##### Counts
3261 | Group Id: OG001
3262 | Value: 260
3263 |
3264 | ##### Categories
3265 |
3266 | ##### Measurements
3267 | Group Id: OG000
3268 | Value: -1.51
3269 | Spread: 2.02
3270 |
3271 | ##### Measurements
3272 | Group Id: OG001
3273 | Value: -1.02
3274 | Spread: 3.04
3275 |
3276 | ##### Classes
3277 | Title: Day 29
3278 |
3279 | ##### Denoms
3280 | Units: Participants
3281 |
3282 | ##### Counts
3283 | Group Id: OG000
3284 | Value: 189
3285 |
3286 | ##### Counts
3287 | Group Id: OG001
3288 | Value: 227
3289 |
3290 | ##### Categories
3291 |
3292 | ##### Measurements
3293 | Group Id: OG000
3294 | Value: -1.02
3295 | Spread: 2.38
3296 |
3297 | ##### Measurements
3298 | Group Id: OG001
3299 | Value: -1.21
3300 | Spread: 7.91
3301 |
3302 | #### Outcome Measures
3303 | Type: SECONDARY
3304 | Title: Change From Baseline in Platelets
3305 | Description:
3306 | Blood to evaluate platelets was collected at Days 1, 3, 5, 8, and 11
3307 | while participants were inpatient, and at Days 15 and 29, with the Day 1
3308 | assessment serving as baseline. Participants who had been discharged had
3309 | blood collected if infection control measures allowed for in-person
3310 | visits after discharge.
3311 | Population Description:
3312 | The safety population includes all treated participants with available
3313 | data at baseline and the post baseline assessment point, analyzed as
3314 | treated.
3315 | Reporting Status: POSTED
3316 | Param Type: MEAN
3317 | Dispersion Type: Standard Deviation
3318 | Unit Of Measure: 10^9 cells/liter
3319 | Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
3320 |
3321 | ##### Groups
3322 | Id: OG000
3323 | Title: Placebo
3324 | Description:
3325 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
3326 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
3327 | while hospitalized for up to a 10 days total course.
3328 |
3329 | ##### Groups
3330 | Id: OG001
3331 | Title: Remdesivir
3332 | Description:
3333 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
3334 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
3335 | up to a 10 days total course.
3336 |
3337 | ##### Denoms
3338 | Units: Participants
3339 |
3340 | ##### Counts
3341 | Group Id: OG000
3342 | Value: 471
3343 |
3344 | ##### Counts
3345 | Group Id: OG001
3346 | Value: 474
3347 |
3348 | ##### Classes
3349 | Title: Day 3
3350 |
3351 | ##### Denoms
3352 | Units: Participants
3353 |
3354 | ##### Counts
3355 | Group Id: OG000
3356 | Value: 471
3357 |
3358 | ##### Counts
3359 | Group Id: OG001
3360 | Value: 474
3361 |
3362 | ##### Categories
3363 |
3364 | ##### Measurements
3365 | Group Id: OG000
3366 | Value: 39.3
3367 | Spread: 60.0
3368 |
3369 | ##### Measurements
3370 | Group Id: OG001
3371 | Value: 46.0
3372 | Spread: 62.6
3373 |
3374 | ##### Classes
3375 | Title: Day 5
3376 |
3377 | ##### Denoms
3378 | Units: Participants
3379 |
3380 | ##### Counts
3381 | Group Id: OG000
3382 | Value: 419
3383 |
3384 | ##### Counts
3385 | Group Id: OG001
3386 | Value: 403
3387 |
3388 | ##### Categories
3389 |
3390 | ##### Measurements
3391 | Group Id: OG000
3392 | Value: 76.5
3393 | Spread: 100.5
3394 |
3395 | ##### Measurements
3396 | Group Id: OG001
3397 | Value: 90.1
3398 | Spread: 99.9
3399 |
3400 | ##### Classes
3401 | Title: Day 8
3402 |
3403 | ##### Denoms
3404 | Units: Participants
3405 |
3406 | ##### Counts
3407 | Group Id: OG000
3408 | Value: 332
3409 |
3410 | ##### Counts
3411 | Group Id: OG001
3412 | Value: 308
3413 |
3414 | ##### Categories
3415 |
3416 | ##### Measurements
3417 | Group Id: OG000
3418 | Value: 111.8
3419 | Spread: 137.4
3420 |
3421 | ##### Measurements
3422 | Group Id: OG001
3423 | Value: 130.8
3424 | Spread: 128.1
3425 |
3426 | ##### Classes
3427 | Title: Day 11
3428 |
3429 | ##### Denoms
3430 | Units: Participants
3431 |
3432 | ##### Counts
3433 | Group Id: OG000
3434 | Value: 269
3435 |
3436 | ##### Counts
3437 | Group Id: OG001
3438 | Value: 229
3439 |
3440 | ##### Categories
3441 |
3442 | ##### Measurements
3443 | Group Id: OG000
3444 | Value: 109.3
3445 | Spread: 149.3
3446 |
3447 | ##### Measurements
3448 | Group Id: OG001
3449 | Value: 101.0
3450 | Spread: 145.0
3451 |
3452 | ##### Classes
3453 | Title: Day 15
3454 |
3455 | ##### Denoms
3456 | Units: Participants
3457 |
3458 | ##### Counts
3459 | Group Id: OG000
3460 | Value: 252
3461 |
3462 | ##### Counts
3463 | Group Id: OG001
3464 | Value: 258
3465 |
3466 | ##### Categories
3467 |
3468 | ##### Measurements
3469 | Group Id: OG000
3470 | Value: 96.5
3471 | Spread: 154.2
3472 |
3473 | ##### Measurements
3474 | Group Id: OG001
3475 | Value: 71.1
3476 | Spread: 133.3
3477 |
3478 | ##### Classes
3479 | Title: Day 29
3480 |
3481 | ##### Denoms
3482 | Units: Participants
3483 |
3484 | ##### Counts
3485 | Group Id: OG000
3486 | Value: 189
3487 |
3488 | ##### Counts
3489 | Group Id: OG001
3490 | Value: 224
3491 |
3492 | ##### Categories
3493 |
3494 | ##### Measurements
3495 | Group Id: OG000
3496 | Value: 32.7
3497 | Spread: 124.2
3498 |
3499 | ##### Measurements
3500 | Group Id: OG001
3501 | Value: 39.6
3502 | Spread: 107.4
3503 |
3504 | #### Outcome Measures
3505 | Type: SECONDARY
3506 | Title: Change From Baseline in Prothrombin Time (PT)
3507 | Description:
3508 | Blood to evaluate PT was collected at Days 1, 3, 5, 8, and 11 while
3509 | participants were inpatient, and at Days 15 and 29, with the Day 1
3510 | assessment serving as baseline. Participants who had been discharged had
3511 | blood collected if infection control measures allowed for in-person
3512 | visits after discharge.
3513 | Population Description:
3514 | The safety population includes all treated participants with available
3515 | data at baseline and the post baseline assessment point, analyzed as
3516 | treated.
3517 | Reporting Status: POSTED
3518 | Param Type: MEAN
3519 | Dispersion Type: Standard Deviation
3520 | Unit Of Measure: seconds
3521 | Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
3522 |
3523 | ##### Groups
3524 | Id: OG000
3525 | Title: Placebo
3526 | Description:
3527 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
3528 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
3529 | while hospitalized for up to a 10 days total course.
3530 |
3531 | ##### Groups
3532 | Id: OG001
3533 | Title: Remdesivir
3534 | Description:
3535 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
3536 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
3537 | up to a 10 days total course.
3538 |
3539 | ##### Denoms
3540 | Units: Participants
3541 |
3542 | ##### Counts
3543 | Group Id: OG000
3544 | Value: 339
3545 |
3546 | ##### Counts
3547 | Group Id: OG001
3548 | Value: 352
3549 |
3550 | ##### Classes
3551 | Title: Day 3
3552 |
3553 | ##### Denoms
3554 | Units: Participants
3555 |
3556 | ##### Counts
3557 | Group Id: OG000
3558 | Value: 339
3559 |
3560 | ##### Counts
3561 | Group Id: OG001
3562 | Value: 352
3563 |
3564 | ##### Categories
3565 |
3566 | ##### Measurements
3567 | Group Id: OG000
3568 | Value: -0.18
3569 | Spread: 4.28
3570 |
3571 | ##### Measurements
3572 | Group Id: OG001
3573 | Value: 0.44
3574 | Spread: 5.22
3575 |
3576 | ##### Classes
3577 | Title: Day 5
3578 |
3579 | ##### Denoms
3580 | Units: Participants
3581 |
3582 | ##### Counts
3583 | Group Id: OG000
3584 | Value: 296
3585 |
3586 | ##### Counts
3587 | Group Id: OG001
3588 | Value: 306
3589 |
3590 | ##### Categories
3591 |
3592 | ##### Measurements
3593 | Group Id: OG000
3594 | Value: -0.30
3595 | Spread: 4.72
3596 |
3597 | ##### Measurements
3598 | Group Id: OG001
3599 | Value: 1.15
3600 | Spread: 5.72
3601 |
3602 | ##### Classes
3603 | Title: Day 8
3604 |
3605 | ##### Denoms
3606 | Units: Participants
3607 |
3608 | ##### Counts
3609 | Group Id: OG000
3610 | Value: 246
3611 |
3612 | ##### Counts
3613 | Group Id: OG001
3614 | Value: 234
3615 |
3616 | ##### Categories
3617 |
3618 | ##### Measurements
3619 | Group Id: OG000
3620 | Value: 0.01
3621 | Spread: 2.59
3622 |
3623 | ##### Measurements
3624 | Group Id: OG001
3625 | Value: 1.43
3626 | Spread: 3.89
3627 |
3628 | ##### Classes
3629 | Title: Day 11
3630 |
3631 | ##### Denoms
3632 | Units: Participants
3633 |
3634 | ##### Counts
3635 | Group Id: OG000
3636 | Value: 199
3637 |
3638 | ##### Counts
3639 | Group Id: OG001
3640 | Value: 182
3641 |
3642 | ##### Categories
3643 |
3644 | ##### Measurements
3645 | Group Id: OG000
3646 | Value: 0.86
3647 | Spread: 7.85
3648 |
3649 | ##### Measurements
3650 | Group Id: OG001
3651 | Value: 1.88
3652 | Spread: 5.68
3653 |
3654 | ##### Classes
3655 | Title: Day 15
3656 |
3657 | ##### Denoms
3658 | Units: Participants
3659 |
3660 | ##### Counts
3661 | Group Id: OG000
3662 | Value: 176
3663 |
3664 | ##### Counts
3665 | Group Id: OG001
3666 | Value: 193
3667 |
3668 | ##### Categories
3669 |
3670 | ##### Measurements
3671 | Group Id: OG000
3672 | Value: 0.34
3673 | Spread: 4.33
3674 |
3675 | ##### Measurements
3676 | Group Id: OG001
3677 | Value: -0.03
3678 | Spread: 4.25
3679 |
3680 | ##### Classes
3681 | Title: Day 29
3682 |
3683 | ##### Denoms
3684 | Units: Participants
3685 |
3686 | ##### Counts
3687 | Group Id: OG000
3688 | Value: 134
3689 |
3690 | ##### Counts
3691 | Group Id: OG001
3692 | Value: 163
3693 |
3694 | ##### Categories
3695 |
3696 | ##### Measurements
3697 | Group Id: OG000
3698 | Value: -0.28
3699 | Spread: 3.20
3700 |
3701 | ##### Measurements
3702 | Group Id: OG001
3703 | Value: -0.63
3704 | Spread: 3.37
3705 |
3706 | #### Outcome Measures
3707 | Type: SECONDARY
3708 | Title: Change From Baseline in Total Bilirubin
3709 | Description:
3710 | Blood to evaluate total bilirubin was collected at Days 1, 3, 5, 8, and
3711 | 11 while participants were inpatient, and at Days 15 and 29, with the
3712 | Day 1 assessment serving as baseline. Participants who had been
3713 | discharged had blood collected if infection control measures allowed for
3714 | in-person visits after discharge.
3715 | Population Description:
3716 | The safety population includes all treated participants with available
3717 | data at baseline and the post baseline assessment point, analyzed as
3718 | treated.
3719 | Reporting Status: POSTED
3720 | Param Type: MEAN
3721 | Dispersion Type: Standard Deviation
3722 | Unit Of Measure: mg/dL
3723 | Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
3724 |
3725 | ##### Groups
3726 | Id: OG000
3727 | Title: Placebo
3728 | Description:
3729 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
3730 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
3731 | while hospitalized for up to a 10 days total course.
3732 |
3733 | ##### Groups
3734 | Id: OG001
3735 | Title: Remdesivir
3736 | Description:
3737 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
3738 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
3739 | up to a 10 days total course.
3740 |
3741 | ##### Denoms
3742 | Units: Participants
3743 |
3744 | ##### Counts
3745 | Group Id: OG000
3746 | Value: 451
3747 |
3748 | ##### Counts
3749 | Group Id: OG001
3750 | Value: 456
3751 |
3752 | ##### Classes
3753 | Title: Day 3
3754 |
3755 | ##### Denoms
3756 | Units: Participants
3757 |
3758 | ##### Counts
3759 | Group Id: OG000
3760 | Value: 451
3761 |
3762 | ##### Counts
3763 | Group Id: OG001
3764 | Value: 456
3765 |
3766 | ##### Categories
3767 |
3768 | ##### Measurements
3769 | Group Id: OG000
3770 | Value: 0.08
3771 | Spread: 1.25
3772 |
3773 | ##### Measurements
3774 | Group Id: OG001
3775 | Value: -0.04
3776 | Spread: 0.75
3777 |
3778 | ##### Classes
3779 | Title: Day 5
3780 |
3781 | ##### Denoms
3782 | Units: Participants
3783 |
3784 | ##### Counts
3785 | Group Id: OG000
3786 | Value: 394
3787 |
3788 | ##### Counts
3789 | Group Id: OG001
3790 | Value: 389
3791 |
3792 | ##### Categories
3793 |
3794 | ##### Measurements
3795 | Group Id: OG000
3796 | Value: 0.58
3797 | Spread: 4.13
3798 |
3799 | ##### Measurements
3800 | Group Id: OG001
3801 | Value: -0.03
3802 | Spread: 1.03
3803 |
3804 | ##### Classes
3805 | Title: Day 8
3806 |
3807 | ##### Denoms
3808 | Units: Participants
3809 |
3810 | ##### Counts
3811 | Group Id: OG000
3812 | Value: 315
3813 |
3814 | ##### Counts
3815 | Group Id: OG001
3816 | Value: 288
3817 |
3818 | ##### Categories
3819 |
3820 | ##### Measurements
3821 | Group Id: OG000
3822 | Value: 0.22
3823 | Spread: 2.56
3824 |
3825 | ##### Measurements
3826 | Group Id: OG001
3827 | Value: 0.01
3828 | Spread: 1.38
3829 |
3830 | ##### Classes
3831 | Title: Day 11
3832 |
3833 | ##### Denoms
3834 | Units: Participants
3835 |
3836 | ##### Counts
3837 | Group Id: OG000
3838 | Value: 247
3839 |
3840 | ##### Counts
3841 | Group Id: OG001
3842 | Value: 220
3843 |
3844 | ##### Categories
3845 |
3846 | ##### Measurements
3847 | Group Id: OG000
3848 | Value: 0.23
3849 | Spread: 2.79
3850 |
3851 | ##### Measurements
3852 | Group Id: OG001
3853 | Value: 0.07
3854 | Spread: 1.48
3855 |
3856 | ##### Classes
3857 | Title: Day 15
3858 |
3859 | ##### Denoms
3860 | Units: Participants
3861 |
3862 | ##### Counts
3863 | Group Id: OG000
3864 | Value: 237
3865 |
3866 | ##### Counts
3867 | Group Id: OG001
3868 | Value: 254
3869 |
3870 | ##### Categories
3871 |
3872 | ##### Measurements
3873 | Group Id: OG000
3874 | Value: 0.00
3875 | Spread: 1.80
3876 |
3877 | ##### Measurements
3878 | Group Id: OG001
3879 | Value: 0.09
3880 | Spread: 1.54
3881 |
3882 | ##### Classes
3883 | Title: Day 29
3884 |
3885 | ##### Denoms
3886 | Units: Participants
3887 |
3888 | ##### Counts
3889 | Group Id: OG000
3890 | Value: 178
3891 |
3892 | ##### Counts
3893 | Group Id: OG001
3894 | Value: 216
3895 |
3896 | ##### Categories
3897 |
3898 | ##### Measurements
3899 | Group Id: OG000
3900 | Value: -0.17
3901 | Spread: 1.65
3902 |
3903 | ##### Measurements
3904 | Group Id: OG001
3905 | Value: -0.12
3906 | Spread: 1.77
3907 |
3908 | #### Outcome Measures
3909 | Type: SECONDARY
3910 | Title: Change From Baseline in White Blood Cell Count (WBC)
3911 | Description:
3912 | Blood to evaluate WBC was collected at Days 1, 3, 5, 8, and 11 while
3913 | participants were inpatient, and at Days 15 and 29, with the Day 1
3914 | assessment serving as baseline. Participants who had been discharged had
3915 | blood collected if infection control measures allowed for in-person
3916 | visits after discharge.
3917 | Population Description:
3918 | The safety population includes all treated participants with available
3919 | data at baseline and the post baseline assessment point, analyzed as
3920 | treated.
3921 | Reporting Status: POSTED
3922 | Param Type: MEAN
3923 | Dispersion Type: Standard Deviation
3924 | Unit Of Measure: 10^9 cells/liter
3925 | Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
3926 |
3927 | ##### Groups
3928 | Id: OG000
3929 | Title: Placebo
3930 | Description:
3931 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
3932 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
3933 | while hospitalized for up to a 10 days total course.
3934 |
3935 | ##### Groups
3936 | Id: OG001
3937 | Title: Remdesivir
3938 | Description:
3939 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
3940 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
3941 | up to a 10 days total course.
3942 |
3943 | ##### Denoms
3944 | Units: Participants
3945 |
3946 | ##### Counts
3947 | Group Id: OG000
3948 | Value: 474
3949 |
3950 | ##### Counts
3951 | Group Id: OG001
3952 | Value: 475
3953 |
3954 | ##### Classes
3955 | Title: Day 3
3956 |
3957 | ##### Denoms
3958 | Units: Participants
3959 |
3960 | ##### Counts
3961 | Group Id: OG000
3962 | Value: 474
3963 |
3964 | ##### Counts
3965 | Group Id: OG001
3966 | Value: 475
3967 |
3968 | ##### Categories
3969 |
3970 | ##### Measurements
3971 | Group Id: OG000
3972 | Value: 18.691
3973 | Spread: 424.837
3974 |
3975 | ##### Measurements
3976 | Group Id: OG001
3977 | Value: -18.970
3978 | Spread: 301.944
3979 |
3980 | ##### Classes
3981 | Title: Day 5
3982 |
3983 | ##### Denoms
3984 | Units: Participants
3985 |
3986 | ##### Counts
3987 | Group Id: OG000
3988 | Value: 419
3989 |
3990 | ##### Counts
3991 | Group Id: OG001
3992 | Value: 405
3993 |
3994 | ##### Categories
3995 |
3996 | ##### Measurements
3997 | Group Id: OG000
3998 | Value: 9.886
3999 | Spread: 566.175
4000 |
4001 | ##### Measurements
4002 | Group Id: OG001
4003 | Value: -28.209
4004 | Spread: 412.615
4005 |
4006 | ##### Classes
4007 | Title: Day 8
4008 |
4009 | ##### Denoms
4010 | Units: Participants
4011 |
4012 | ##### Counts
4013 | Group Id: OG000
4014 | Value: 333
4015 |
4016 | ##### Counts
4017 | Group Id: OG001
4018 | Value: 310
4019 |
4020 | ##### Categories
4021 |
4022 | ##### Measurements
4023 | Group Id: OG000
4024 | Value: 27.223
4025 | Spread: 479.095
4026 |
4027 | ##### Measurements
4028 | Group Id: OG001
4029 | Value: -45.997
4030 | Spread: 602.461
4031 |
4032 | ##### Classes
4033 | Title: Day 11
4034 |
4035 | ##### Denoms
4036 | Units: Participants
4037 |
4038 | ##### Counts
4039 | Group Id: OG000
4040 | Value: 268
4041 |
4042 | ##### Counts
4043 | Group Id: OG001
4044 | Value: 230
4045 |
4046 | ##### Categories
4047 |
4048 | ##### Measurements
4049 | Group Id: OG000
4050 | Value: 1.967
4051 | Spread: 16.042
4052 |
4053 | ##### Measurements
4054 | Group Id: OG001
4055 | Value: -34.702
4056 | Spread: 574.065
4057 |
4058 | ##### Classes
4059 | Title: Day 15
4060 |
4061 | ##### Denoms
4062 | Units: Participants
4063 |
4064 | ##### Counts
4065 | Group Id: OG000
4066 | Value: 252
4067 |
4068 | ##### Counts
4069 | Group Id: OG001
4070 | Value: 260
4071 |
4072 | ##### Categories
4073 |
4074 | ##### Measurements
4075 | Group Id: OG000
4076 | Value: 56.311
4077 | Spread: 620.551
4078 |
4079 | ##### Measurements
4080 | Group Id: OG001
4081 | Value: -70.884
4082 | Spread: 600.011
4083 |
4084 | ##### Classes
4085 | Title: Day 29
4086 |
4087 | ##### Denoms
4088 | Units: Participants
4089 |
4090 | ##### Counts
4091 | Group Id: OG000
4092 | Value: 189
4093 |
4094 | ##### Counts
4095 | Group Id: OG001
4096 | Value: 226
4097 |
4098 | ##### Categories
4099 |
4100 | ##### Measurements
4101 | Group Id: OG000
4102 | Value: -0.898
4103 | Spread: 17.801
4104 |
4105 | ##### Measurements
4106 | Group Id: OG001
4107 | Value: 0.251
4108 | Spread: 3.987
4109 |
4110 | #### Outcome Measures
4111 | Type: SECONDARY
4112 | Title: Change From Baseline in Neutrophils
4113 | Description:
4114 | Blood to evaluate neutrophils was collected at Days 1, 3, 5, 8, and 11
4115 | while participants were inpatient, and at Days 15 and 29, with the Day 1
4116 | assessment serving as baseline. Participants who had been discharged had
4117 | blood collected if infection control measures allowed for in-person
4118 | visits after discharge.
4119 | Population Description:
4120 | The safety population includes all treated participants with available
4121 | data at baseline and the post baseline assessment point, analyzed as
4122 | treated.
4123 | Reporting Status: POSTED
4124 | Param Type: MEAN
4125 | Dispersion Type: Standard Deviation
4126 | Unit Of Measure: 10^9 cells/liter
4127 | Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
4128 |
4129 | ##### Groups
4130 | Id: OG000
4131 | Title: Placebo
4132 | Description:
4133 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
4134 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
4135 | while hospitalized for up to a 10 days total course.
4136 |
4137 | ##### Groups
4138 | Id: OG001
4139 | Title: Remdesivir
4140 | Description:
4141 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
4142 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
4143 | up to a 10 days total course.
4144 |
4145 | ##### Denoms
4146 | Units: Participants
4147 |
4148 | ##### Counts
4149 | Group Id: OG000
4150 | Value: 463
4151 |
4152 | ##### Counts
4153 | Group Id: OG001
4154 | Value: 459
4155 |
4156 | ##### Classes
4157 | Title: Day 3
4158 |
4159 | ##### Denoms
4160 | Units: Participants
4161 |
4162 | ##### Counts
4163 | Group Id: OG000
4164 | Value: 463
4165 |
4166 | ##### Counts
4167 | Group Id: OG001
4168 | Value: 459
4169 |
4170 | ##### Categories
4171 |
4172 | ##### Measurements
4173 | Group Id: OG000
4174 | Value: 9.429
4175 | Spread: 260.345
4176 |
4177 | ##### Measurements
4178 | Group Id: OG001
4179 | Value: -8.093
4180 | Spread: 135.068
4181 |
4182 | ##### Classes
4183 | Title: Day 5
4184 |
4185 | ##### Denoms
4186 | Units: Participants
4187 |
4188 | ##### Counts
4189 | Group Id: OG000
4190 | Value: 406
4191 |
4192 | ##### Counts
4193 | Group Id: OG001
4194 | Value: 389
4195 |
4196 | ##### Categories
4197 |
4198 | ##### Measurements
4199 | Group Id: OG000
4200 | Value: 4.177
4201 | Spread: 362.782
4202 |
4203 | ##### Measurements
4204 | Group Id: OG001
4205 | Value: -15.067
4206 | Spread: 216.532
4207 |
4208 | ##### Classes
4209 | Title: Day 8
4210 |
4211 | ##### Denoms
4212 | Units: Participants
4213 |
4214 | ##### Counts
4215 | Group Id: OG000
4216 | Value: 317
4217 |
4218 | ##### Counts
4219 | Group Id: OG001
4220 | Value: 298
4221 |
4222 | ##### Categories
4223 |
4224 | ##### Measurements
4225 | Group Id: OG000
4226 | Value: 17.916
4227 | Spread: 305.321
4228 |
4229 | ##### Measurements
4230 | Group Id: OG001
4231 | Value: -28.179
4232 | Spread: 365.099
4233 |
4234 | ##### Classes
4235 | Title: Day 11
4236 |
4237 | ##### Denoms
4238 | Units: Participants
4239 |
4240 | ##### Counts
4241 | Group Id: OG000
4242 | Value: 257
4243 |
4244 | ##### Counts
4245 | Group Id: OG001
4246 | Value: 220
4247 |
4248 | ##### Categories
4249 |
4250 | ##### Measurements
4251 | Group Id: OG000
4252 | Value: 3.010
4253 | Spread: 27.502
4254 |
4255 | ##### Measurements
4256 | Group Id: OG001
4257 | Value: -21.773
4258 | Spread: 354.025
4259 |
4260 | ##### Classes
4261 | Title: Day 15
4262 |
4263 | ##### Denoms
4264 | Units: Participants
4265 |
4266 | ##### Counts
4267 | Group Id: OG000
4268 | Value: 241
4269 |
4270 | ##### Counts
4271 | Group Id: OG001
4272 | Value: 253
4273 |
4274 | ##### Categories
4275 |
4276 | ##### Measurements
4277 | Group Id: OG000
4278 | Value: 36.024
4279 | Spread: 389.093
4280 |
4281 | ##### Measurements
4282 | Group Id: OG001
4283 | Value: -39.988
4284 | Spread: 333.088
4285 |
4286 | ##### Classes
4287 | Title: Day 29
4288 |
4289 | ##### Denoms
4290 | Units: Participants
4291 |
4292 | ##### Counts
4293 | Group Id: OG000
4294 | Value: 177
4295 |
4296 | ##### Counts
4297 | Group Id: OG001
4298 | Value: 218
4299 |
4300 | ##### Categories
4301 |
4302 | ##### Measurements
4303 | Group Id: OG000
4304 | Value: -1.269
4305 | Spread: 7.160
4306 |
4307 | ##### Measurements
4308 | Group Id: OG001
4309 | Value: -0.840
4310 | Spread: 3.666
4311 |
4312 | #### Outcome Measures
4313 | Type: SECONDARY
4314 | Title: Change From Baseline in Lymphocytes
4315 | Description:
4316 | Blood to evaluate lymphocytes was collected at Days 1, 3, 5, 8, and 11
4317 | while participants were inpatient, and at Days 15 and 29, with the Day 1
4318 | assessment serving as baseline. Participants who had been discharged had
4319 | blood collected if infection control measures allowed for in-person
4320 | visits after discharge.
4321 | Population Description:
4322 | The safety population includes all treated participants with available
4323 | data at baseline and the post baseline assessment point, analyzed as
4324 | treated.
4325 | Reporting Status: POSTED
4326 | Param Type: MEAN
4327 | Dispersion Type: Standard Deviation
4328 | Unit Of Measure: 10^9 cells/liter
4329 | Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
4330 |
4331 | ##### Groups
4332 | Id: OG000
4333 | Title: Placebo
4334 | Description:
4335 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
4336 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
4337 | while hospitalized for up to a 10 days total course.
4338 |
4339 | ##### Groups
4340 | Id: OG001
4341 | Title: Remdesivir
4342 | Description:
4343 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
4344 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
4345 | up to a 10 days total course.
4346 |
4347 | ##### Denoms
4348 | Units: Participants
4349 |
4350 | ##### Counts
4351 | Group Id: OG000
4352 | Value: 463
4353 |
4354 | ##### Counts
4355 | Group Id: OG001
4356 | Value: 459
4357 |
4358 | ##### Classes
4359 | Title: Day 3
4360 |
4361 | ##### Denoms
4362 | Units: Participants
4363 |
4364 | ##### Counts
4365 | Group Id: OG000
4366 | Value: 463
4367 |
4368 | ##### Counts
4369 | Group Id: OG001
4370 | Value: 459
4371 |
4372 | ##### Categories
4373 |
4374 | ##### Measurements
4375 | Group Id: OG000
4376 | Value: 5.883
4377 | Spread: 118.740
4378 |
4379 | ##### Measurements
4380 | Group Id: OG001
4381 | Value: -7.847
4382 | Spread: 131.548
4383 |
4384 | ##### Classes
4385 | Title: Day 5
4386 |
4387 | ##### Denoms
4388 | Units: Participants
4389 |
4390 | ##### Counts
4391 | Group Id: OG000
4392 | Value: 406
4393 |
4394 | ##### Counts
4395 | Group Id: OG001
4396 | Value: 389
4397 |
4398 | ##### Categories
4399 |
4400 | ##### Measurements
4401 | Group Id: OG000
4402 | Value: 4.064
4403 | Spread: 141.580
4404 |
4405 | ##### Measurements
4406 | Group Id: OG001
4407 | Value: -11.723
4408 | Spread: 167.428
4409 |
4410 | ##### Classes
4411 | Title: Day 8
4412 |
4413 | ##### Denoms
4414 | Units: Participants
4415 |
4416 | ##### Counts
4417 | Group Id: OG000
4418 | Value: 317
4419 |
4420 | ##### Counts
4421 | Group Id: OG001
4422 | Value: 299
4423 |
4424 | ##### Categories
4425 |
4426 | ##### Measurements
4427 | Group Id: OG000
4428 | Value: 8.006
4429 | Spread: 137.149
4430 |
4431 | ##### Measurements
4432 | Group Id: OG001
4433 | Value: -15.455
4434 | Spread: 194.111
4435 |
4436 | ##### Classes
4437 | Title: Day 11
4438 |
4439 | ##### Denoms
4440 | Units: Participants
4441 |
4442 | ##### Counts
4443 | Group Id: OG000
4444 | Value: 257
4445 |
4446 | ##### Counts
4447 | Group Id: OG001
4448 | Value: 220
4449 |
4450 | ##### Categories
4451 |
4452 | ##### Measurements
4453 | Group Id: OG000
4454 | Value: 0.393
4455 | Spread: 1.371
4456 |
4457 | ##### Measurements
4458 | Group Id: OG001
4459 | Value: -12.016
4460 | Spread: 183.060
4461 |
4462 | ##### Classes
4463 | Title: Day 15
4464 |
4465 | ##### Denoms
4466 | Units: Participants
4467 |
4468 | ##### Counts
4469 | Group Id: OG000
4470 | Value: 241
4471 |
4472 | ##### Counts
4473 | Group Id: OG001
4474 | Value: 253
4475 |
4476 | ##### Categories
4477 |
4478 | ##### Measurements
4479 | Group Id: OG000
4480 | Value: 14.793
4481 | Spread: 159.583
4482 |
4483 | ##### Measurements
4484 | Group Id: OG001
4485 | Value: -23.836
4486 | Spread: 218.653
4487 |
4488 | ##### Classes
4489 | Title: Day 29
4490 |
4491 | ##### Denoms
4492 | Units: Participants
4493 |
4494 | ##### Counts
4495 | Group Id: OG000
4496 | Value: 177
4497 |
4498 | ##### Counts
4499 | Group Id: OG001
4500 | Value: 218
4501 |
4502 | ##### Categories
4503 |
4504 | ##### Measurements
4505 | Group Id: OG000
4506 | Value: 0.668
4507 | Spread: 1.406
4508 |
4509 | ##### Measurements
4510 | Group Id: OG001
4511 | Value: 0.743
4512 | Spread: 0.664
4513 |
4514 | #### Outcome Measures
4515 | Type: SECONDARY
4516 | Title: Change From Baseline in Monocytes
4517 | Description:
4518 | Blood to evaluate monocytes was collected at Days 1, 3, 5, 8, and 11
4519 | while participants were inpatient, and at Days 15 and 29, with the Day 1
4520 | assessment serving as baseline. Participants who had been discharged had
4521 | blood collected if infection control measures allowed for in-person
4522 | visits after discharge.
4523 | Population Description:
4524 | The safety population includes all treated participants with available
4525 | data at baseline and the post baseline assessment point, analyzed as
4526 | treated.
4527 | Reporting Status: POSTED
4528 | Param Type: MEAN
4529 | Dispersion Type: Standard Deviation
4530 | Unit Of Measure: 10^9 cells/liter
4531 | Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
4532 |
4533 | ##### Groups
4534 | Id: OG000
4535 | Title: Placebo
4536 | Description:
4537 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
4538 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
4539 | while hospitalized for up to a 10 days total course.
4540 |
4541 | ##### Groups
4542 | Id: OG001
4543 | Title: Remdesivir
4544 | Description:
4545 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
4546 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
4547 | up to a 10 days total course.
4548 |
4549 | ##### Denoms
4550 | Units: Participants
4551 |
4552 | ##### Counts
4553 | Group Id: OG000
4554 | Value: 463
4555 |
4556 | ##### Counts
4557 | Group Id: OG001
4558 | Value: 458
4559 |
4560 | ##### Classes
4561 | Title: Day 3
4562 |
4563 | ##### Denoms
4564 | Units: Participants
4565 |
4566 | ##### Counts
4567 | Group Id: OG000
4568 | Value: 463
4569 |
4570 | ##### Counts
4571 | Group Id: OG001
4572 | Value: 458
4573 |
4574 | ##### Categories
4575 |
4576 | ##### Measurements
4577 | Group Id: OG000
4578 | Value: 2.448
4579 | Spread: 41.304
4580 |
4581 | ##### Measurements
4582 | Group Id: OG001
4583 | Value: -2.940
4584 | Spread: 46.752
4585 |
4586 | ##### Classes
4587 | Title: Day 5
4588 |
4589 | ##### Denoms
4590 | Units: Participants
4591 |
4592 | ##### Counts
4593 | Group Id: OG000
4594 | Value: 406
4595 |
4596 | ##### Counts
4597 | Group Id: OG001
4598 | Value: 388
4599 |
4600 | ##### Categories
4601 |
4602 | ##### Measurements
4603 | Group Id: OG000
4604 | Value: 1.498
4605 | Spread: 57.686
4606 |
4607 | ##### Measurements
4608 | Group Id: OG001
4609 | Value: -2.628
4610 | Spread: 39.329
4611 |
4612 | ##### Classes
4613 | Title: Day 8
4614 |
4615 | ##### Denoms
4616 | Units: Participants
4617 |
4618 | ##### Counts
4619 | Group Id: OG000
4620 | Value: 316
4621 |
4622 | ##### Counts
4623 | Group Id: OG001
4624 | Value: 299
4625 |
4626 | ##### Categories
4627 |
4628 | ##### Measurements
4629 | Group Id: OG000
4630 | Value: 2.324
4631 | Spread: 36.626
4632 |
4633 | ##### Measurements
4634 | Group Id: OG001
4635 | Value: -3.645
4636 | Spread: 48.636
4637 |
4638 | ##### Classes
4639 | Title: Day 11
4640 |
4641 | ##### Denoms
4642 | Units: Participants
4643 |
4644 | ##### Counts
4645 | Group Id: OG000
4646 | Value: 257
4647 |
4648 | ##### Counts
4649 | Group Id: OG001
4650 | Value: 220
4651 |
4652 | ##### Categories
4653 |
4654 | ##### Measurements
4655 | Group Id: OG000
4656 | Value: 0.383
4657 | Spread: 0.744
4658 |
4659 | ##### Measurements
4660 | Group Id: OG001
4661 | Value: -2.539
4662 | Spread: 43.454
4663 |
4664 | ##### Classes
4665 | Title: Day 15
4666 |
4667 | ##### Denoms
4668 | Units: Participants
4669 |
4670 | ##### Counts
4671 | Group Id: OG000
4672 | Value: 241
4673 |
4674 | ##### Counts
4675 | Group Id: OG001
4676 | Value: 253
4677 |
4678 | ##### Categories
4679 |
4680 | ##### Measurements
4681 | Group Id: OG000
4682 | Value: 6.475
4683 | Spread: 69.019
4684 |
4685 | ##### Measurements
4686 | Group Id: OG001
4687 | Value: -8.738
4688 | Spread: 74.365
4689 |
4690 | ##### Classes
4691 | Title: Day 29
4692 |
4693 | ##### Denoms
4694 | Units: Participants
4695 |
4696 | ##### Counts
4697 | Group Id: OG000
4698 | Value: 177
4699 |
4700 | ##### Counts
4701 | Group Id: OG001
4702 | Value: 218
4703 |
4704 | ##### Categories
4705 |
4706 | ##### Measurements
4707 | Group Id: OG000
4708 | Value: 0.125
4709 | Spread: 0.485
4710 |
4711 | ##### Measurements
4712 | Group Id: OG001
4713 | Value: 0.117
4714 | Spread: 0.340
4715 |
4716 | #### Outcome Measures
4717 | Type: SECONDARY
4718 | Title: Change From Baseline in Basophils
4719 | Description:
4720 | Blood to evaluate basophils was collected at Days 1, 3, 5, 8, and 11
4721 | while participants were inpatient, and at Days 15 and 29, with the Day 1
4722 | assessment serving as baseline. Participants who had been discharged had
4723 | blood collected if infection control measures allowed for in-person
4724 | visits after discharge.
4725 | Population Description:
4726 | The safety population includes all treated participants with available
4727 | data at baseline and the post baseline assessment point, analyzed as
4728 | treated.
4729 | Reporting Status: POSTED
4730 | Param Type: MEAN
4731 | Dispersion Type: Standard Deviation
4732 | Unit Of Measure: 10^9 cells/liter
4733 | Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
4734 |
4735 | ##### Groups
4736 | Id: OG000
4737 | Title: Placebo
4738 | Description:
4739 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
4740 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
4741 | while hospitalized for up to a 10 days total course.
4742 |
4743 | ##### Groups
4744 | Id: OG001
4745 | Title: Remdesivir
4746 | Description:
4747 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
4748 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
4749 | up to a 10 days total course.
4750 |
4751 | ##### Denoms
4752 | Units: Participants
4753 |
4754 | ##### Counts
4755 | Group Id: OG000
4756 | Value: 455
4757 |
4758 | ##### Counts
4759 | Group Id: OG001
4760 | Value: 452
4761 |
4762 | ##### Classes
4763 | Title: Day 3
4764 |
4765 | ##### Denoms
4766 | Units: Participants
4767 |
4768 | ##### Counts
4769 | Group Id: OG000
4770 | Value: 455
4771 |
4772 | ##### Counts
4773 | Group Id: OG001
4774 | Value: 452
4775 |
4776 | ##### Categories
4777 |
4778 | ##### Measurements
4779 | Group Id: OG000
4780 | Value: 0.020
4781 | Spread: 0.257
4782 |
4783 | ##### Measurements
4784 | Group Id: OG001
4785 | Value: 0.005
4786 | Spread: 0.043
4787 |
4788 | ##### Classes
4789 | Title: Day 5
4790 |
4791 | ##### Denoms
4792 | Units: Participants
4793 |
4794 | ##### Counts
4795 | Group Id: OG000
4796 | Value: 394
4797 |
4798 | ##### Counts
4799 | Group Id: OG001
4800 | Value: 380
4801 |
4802 | ##### Categories
4803 |
4804 | ##### Measurements
4805 | Group Id: OG000
4806 | Value: 0.038
4807 | Spread: 0.501
4808 |
4809 | ##### Measurements
4810 | Group Id: OG001
4811 | Value: 0.005
4812 | Spread: 0.370
4813 |
4814 | ##### Classes
4815 | Title: Day 8
4816 |
4817 | ##### Denoms
4818 | Units: Participants
4819 |
4820 | ##### Counts
4821 | Group Id: OG000
4822 | Value: 309
4823 |
4824 | ##### Counts
4825 | Group Id: OG001
4826 | Value: 293
4827 |
4828 | ##### Categories
4829 |
4830 | ##### Measurements
4831 | Group Id: OG000
4832 | Value: 0.196
4833 | Spread: 3.132
4834 |
4835 | ##### Measurements
4836 | Group Id: OG001
4837 | Value: 0.005
4838 | Spread: 0.368
4839 |
4840 | ##### Classes
4841 | Title: Day 11
4842 |
4843 | ##### Denoms
4844 | Units: Participants
4845 |
4846 | ##### Counts
4847 | Group Id: OG000
4848 | Value: 253
4849 |
4850 | ##### Counts
4851 | Group Id: OG001
4852 | Value: 218
4853 |
4854 | ##### Categories
4855 |
4856 | ##### Measurements
4857 | Group Id: OG000
4858 | Value: 0.024
4859 | Spread: 0.042
4860 |
4861 | ##### Measurements
4862 | Group Id: OG001
4863 | Value: 0.028
4864 | Spread: 0.053
4865 |
4866 | ##### Classes
4867 | Title: Day 15
4868 |
4869 | ##### Denoms
4870 | Units: Participants
4871 |
4872 | ##### Counts
4873 | Group Id: OG000
4874 | Value: 235
4875 |
4876 | ##### Counts
4877 | Group Id: OG001
4878 | Value: 248
4879 |
4880 | ##### Categories
4881 |
4882 | ##### Measurements
4883 | Group Id: OG000
4884 | Value: 0.158
4885 | Spread: 1.913
4886 |
4887 | ##### Measurements
4888 | Group Id: OG001
4889 | Value: -0.058
4890 | Spread: 1.028
4891 |
4892 | ##### Classes
4893 | Title: Day 29
4894 |
4895 | ##### Denoms
4896 | Units: Participants
4897 |
4898 | ##### Counts
4899 | Group Id: OG000
4900 | Value: 176
4901 |
4902 | ##### Counts
4903 | Group Id: OG001
4904 | Value: 216
4905 |
4906 | ##### Categories
4907 |
4908 | ##### Measurements
4909 | Group Id: OG000
4910 | Value: 0.040
4911 | Spread: 0.073
4912 |
4913 | ##### Measurements
4914 | Group Id: OG001
4915 | Value: 0.029
4916 | Spread: 0.054
4917 |
4918 | #### Outcome Measures
4919 | Type: SECONDARY
4920 | Title: Change From Baseline in Eosinophils
4921 | Description:
4922 | Blood to evaluate eosinophils was collected at Days 1, 3, 5, 8, and 11
4923 | while participants were inpatient, and at Days 15 and 29, with the Day 1
4924 | assessment serving as baseline. Participants who had been discharged had
4925 | blood collected if infection control measures allowed for in-person
4926 | visits after discharge.
4927 | Population Description:
4928 | The safety population includes all treated participants with available
4929 | data at baseline and the post baseline assessment point, analyzed as
4930 | treated.
4931 | Reporting Status: POSTED
4932 | Param Type: MEAN
4933 | Dispersion Type: Standard Deviation
4934 | Unit Of Measure: 10^9 cells/liter
4935 | Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
4936 |
4937 | ##### Groups
4938 | Id: OG000
4939 | Title: Placebo
4940 | Description:
4941 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
4942 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
4943 | while hospitalized for up to a 10 days total course.
4944 |
4945 | ##### Groups
4946 | Id: OG001
4947 | Title: Remdesivir
4948 | Description:
4949 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
4950 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
4951 | up to a 10 days total course.
4952 |
4953 | ##### Denoms
4954 | Units: Participants
4955 |
4956 | ##### Counts
4957 | Group Id: OG000
4958 | Value: 456
4959 |
4960 | ##### Counts
4961 | Group Id: OG001
4962 | Value: 455
4963 |
4964 | ##### Classes
4965 | Title: Day 3
4966 |
4967 | ##### Denoms
4968 | Units: Participants
4969 |
4970 | ##### Counts
4971 | Group Id: OG000
4972 | Value: 456
4973 |
4974 | ##### Counts
4975 | Group Id: OG001
4976 | Value: 455
4977 |
4978 | ##### Categories
4979 |
4980 | ##### Measurements
4981 | Group Id: OG000
4982 | Value: 0.634
4983 | Spread: 10.614
4984 |
4985 | ##### Measurements
4986 | Group Id: OG001
4987 | Value: 0.016
4988 | Spread: 0.727
4989 |
4990 | ##### Classes
4991 | Title: Day 5
4992 |
4993 | ##### Denoms
4994 | Units: Participants
4995 |
4996 | ##### Counts
4997 | Group Id: OG000
4998 | Value: 397
4999 |
5000 | ##### Counts
5001 | Group Id: OG001
5002 | Value: 387
5003 |
5004 | ##### Categories
5005 |
5006 | ##### Measurements
5007 | Group Id: OG000
5008 | Value: 0.666
5009 | Spread: 11.977
5010 |
5011 | ##### Measurements
5012 | Group Id: OG001
5013 | Value: -0.066
5014 | Spread: 2.807
5015 |
5016 | ##### Classes
5017 | Title: Day 8
5018 |
5019 | ##### Denoms
5020 | Units: Participants
5021 |
5022 | ##### Counts
5023 | Group Id: OG000
5024 | Value: 311
5025 |
5026 | ##### Counts
5027 | Group Id: OG001
5028 | Value: 293
5029 |
5030 | ##### Categories
5031 |
5032 | ##### Measurements
5033 | Group Id: OG000
5034 | Value: 0.596
5035 | Spread: 8.875
5036 |
5037 | ##### Measurements
5038 | Group Id: OG001
5039 | Value: -0.221
5040 | Spread: 4.108
5041 |
5042 | ##### Classes
5043 | Title: Day 11
5044 |
5045 | ##### Denoms
5046 | Units: Participants
5047 |
5048 | ##### Counts
5049 | Group Id: OG000
5050 | Value: 254
5051 |
5052 | ##### Counts
5053 | Group Id: OG001
5054 | Value: 218
5055 |
5056 | ##### Categories
5057 |
5058 | ##### Measurements
5059 | Group Id: OG000
5060 | Value: 0.093
5061 | Spread: 0.190
5062 |
5063 | ##### Measurements
5064 | Group Id: OG001
5065 | Value: -0.088
5066 | Spread: 2.973
5067 |
5068 | ##### Classes
5069 | Title: Day 15
5070 |
5071 | ##### Denoms
5072 | Units: Participants
5073 |
5074 | ##### Counts
5075 | Group Id: OG000
5076 | Value: 237
5077 |
5078 | ##### Counts
5079 | Group Id: OG001
5080 | Value: 251
5081 |
5082 | ##### Categories
5083 |
5084 | ##### Measurements
5085 | Group Id: OG000
5086 | Value: 1.992
5087 | Spread: 20.365
5088 |
5089 | ##### Measurements
5090 | Group Id: OG001
5091 | Value: -0.420
5092 | Spread: 5.378
5093 |
5094 | ##### Classes
5095 | Title: Day 29
5096 |
5097 | ##### Denoms
5098 | Units: Participants
5099 |
5100 | ##### Counts
5101 | Group Id: OG000
5102 | Value: 176
5103 |
5104 | ##### Counts
5105 | Group Id: OG001
5106 | Value: 217
5107 |
5108 | ##### Categories
5109 |
5110 | ##### Measurements
5111 | Group Id: OG000
5112 | Value: 0.241
5113 | Spread: 0.324
5114 |
5115 | ##### Measurements
5116 | Group Id: OG001
5117 | Value: 0.211
5118 | Spread: 0.267
5119 |
5120 | #### Outcome Measures
5121 | Type: SECONDARY
5122 | Title: Change in National Early Warning Score (NEWS) From Baseline
5123 | Description:
5124 | The NEW score has demonstrated an ability to discriminate patients at
5125 | risk of poor outcomes. This score is based on 7 clinical parameters
5126 | (respiration rate, oxygen saturation, any supplemental oxygen,
5127 | temperature, systolic blood pressure, heart rate, level of
5128 | consciousness). The NEW Score is being used as an efficacy measure. The
5129 | minimum score is 0, representing the better outcome, and the maximum
5130 | value is 19, representing the worse outcome.
5131 | Population Description:
5132 | The intent-to-treat (ITT) population includes all participants who were
5133 | randomized with data at baseline and at each timepoint.
5134 | Reporting Status: POSTED
5135 | Param Type: MEAN
5136 | Dispersion Type: Standard Deviation
5137 | Unit Of Measure: units on a scale
5138 | Time Frame: Days 1, 3, 5, 8, 11, 15, 22, and 29
5139 |
5140 | ##### Groups
5141 | Id: OG000
5142 | Title: Placebo
5143 | Description:
5144 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
5145 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
5146 | while hospitalized for up to a 10 days total course.
5147 |
5148 | ##### Groups
5149 | Id: OG001
5150 | Title: Remdesivir
5151 | Description:
5152 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
5153 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
5154 | up to a 10 days total course.
5155 |
5156 | ##### Denoms
5157 | Units: Participants
5158 |
5159 | ##### Counts
5160 | Group Id: OG000
5161 | Value: 499
5162 |
5163 | ##### Counts
5164 | Group Id: OG001
5165 | Value: 502
5166 |
5167 | ##### Classes
5168 | Title: Day 3
5169 |
5170 | ##### Denoms
5171 | Units: Participants
5172 |
5173 | ##### Counts
5174 | Group Id: OG000
5175 | Value: 499
5176 |
5177 | ##### Counts
5178 | Group Id: OG001
5179 | Value: 502
5180 |
5181 | ##### Categories
5182 |
5183 | ##### Measurements
5184 | Group Id: OG000
5185 | Value: 0.1
5186 | Spread: 2.8
5187 |
5188 | ##### Measurements
5189 | Group Id: OG001
5190 | Value: -0.3
5191 | Spread: 2.6
5192 |
5193 | ##### Classes
5194 | Title: Day 5
5195 |
5196 | ##### Denoms
5197 | Units: Participants
5198 |
5199 | ##### Counts
5200 | Group Id: OG000
5201 | Value: 447
5202 |
5203 | ##### Counts
5204 | Group Id: OG001
5205 | Value: 438
5206 |
5207 | ##### Categories
5208 |
5209 | ##### Measurements
5210 | Group Id: OG000
5211 | Value: 0.3
5212 | Spread: 3.3
5213 |
5214 | ##### Measurements
5215 | Group Id: OG001
5216 | Value: -0.4
5217 | Spread: 2.9
5218 |
5219 | ##### Classes
5220 | Title: Day 8
5221 |
5222 | ##### Denoms
5223 | Units: Participants
5224 |
5225 | ##### Counts
5226 | Group Id: OG000
5227 | Value: 348
5228 |
5229 | ##### Counts
5230 | Group Id: OG001
5231 | Value: 321
5232 |
5233 | ##### Categories
5234 |
5235 | ##### Measurements
5236 | Group Id: OG000
5237 | Value: -0.3
5238 | Spread: 3.8
5239 |
5240 | ##### Measurements
5241 | Group Id: OG001
5242 | Value: -0.5
5243 | Spread: 3.2
5244 |
5245 | ##### Classes
5246 | Title: Day 11
5247 |
5248 | ##### Denoms
5249 | Units: Participants
5250 |
5251 | ##### Counts
5252 | Group Id: OG000
5253 | Value: 291
5254 |
5255 | ##### Counts
5256 | Group Id: OG001
5257 | Value: 254
5258 |
5259 | ##### Categories
5260 |
5261 | ##### Measurements
5262 | Group Id: OG000
5263 | Value: -0.3
5264 | Spread: 4.1
5265 |
5266 | ##### Measurements
5267 | Group Id: OG001
5268 | Value: -0.5
5269 | Spread: 3.5
5270 |
5271 | ##### Classes
5272 | Title: Day 15
5273 |
5274 | ##### Denoms
5275 | Units: Participants
5276 |
5277 | ##### Counts
5278 | Group Id: OG000
5279 | Value: 290
5280 |
5281 | ##### Counts
5282 | Group Id: OG001
5283 | Value: 301
5284 |
5285 | ##### Categories
5286 |
5287 | ##### Measurements
5288 | Group Id: OG000
5289 | Value: -1.4
5290 | Spread: 4.2
5291 |
5292 | ##### Measurements
5293 | Group Id: OG001
5294 | Value: -1.7
5295 | Spread: 3.6
5296 |
5297 | ##### Classes
5298 | Title: Day 22
5299 |
5300 | ##### Denoms
5301 | Units: Participants
5302 |
5303 | ##### Counts
5304 | Group Id: OG000
5305 | Value: 151
5306 |
5307 | ##### Counts
5308 | Group Id: OG001
5309 | Value: 120
5310 |
5311 | ##### Categories
5312 |
5313 | ##### Measurements
5314 | Group Id: OG000
5315 | Value: -1.4
5316 | Spread: 4.0
5317 |
5318 | ##### Measurements
5319 | Group Id: OG001
5320 | Value: -1.7
5321 | Spread: 4.1
5322 |
5323 | ##### Classes
5324 | Title: Day 29
5325 |
5326 | ##### Denoms
5327 | Units: Participants
5328 |
5329 | ##### Counts
5330 | Group Id: OG000
5331 | Value: 221
5332 |
5333 | ##### Counts
5334 | Group Id: OG001
5335 | Value: 251
5336 |
5337 | ##### Categories
5338 |
5339 | ##### Measurements
5340 | Group Id: OG000
5341 | Value: -3.2
5342 | Spread: 4.0
5343 |
5344 | ##### Measurements
5345 | Group Id: OG001
5346 | Value: -3.3
5347 | Spread: 3.2
5348 |
5349 | #### Outcome Measures
5350 | Type: SECONDARY
5351 | Title:
5352 | Percentage of Participants at Each Clinical Status Using Ordinal Scale
5353 | at Day 1
5354 | Description:
5355 | The ordinal scale is an assessment of the clinical status at the first
5356 | assessment of a given study day. The scale is as follows: 8) Death; 7)
5357 | Hospitalized, on invasive mechanical ventilation or extracorporeal
5358 | membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
5359 | ventilation or high flow oxygen devices; 5) Hospitalized, requiring
5360 | supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
5361 | - requiring ongoing medical care (COVID-19 related or otherwise); 3)
5362 | Hospitalized, not requiring supplemental oxygen - no longer requires
5363 | ongoing medical care; 2) Not hospitalized, limitation on activities
5364 | and/or requiring home oxygen; 1) Not hospitalized, no limitations on
5365 | activities.
5366 | Population Description:
5367 | The intent-to-treat (ITT) population includes all participants who were
5368 | randomized
5369 | Reporting Status: POSTED
5370 | Param Type: NUMBER
5371 | Dispersion Type: 95% Confidence Interval
5372 | Unit Of Measure: percentage of participants
5373 | Time Frame: Day 1
5374 |
5375 | ##### Groups
5376 | Id: OG000
5377 | Title: Placebo
5378 | Description:
5379 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
5380 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
5381 | while hospitalized for up to a 10 days total course.
5382 |
5383 | ##### Groups
5384 | Id: OG001
5385 | Title: Remdesivir
5386 | Description:
5387 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
5388 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
5389 | up to a 10 days total course.
5390 |
5391 | ##### Denoms
5392 | Units: Participants
5393 |
5394 | ##### Counts
5395 | Group Id: OG000
5396 | Value: 521
5397 |
5398 | ##### Counts
5399 | Group Id: OG001
5400 | Value: 541
5401 |
5402 | ##### Classes
5403 | Title: Death at or before study Visit
5404 |
5405 | ##### Categories
5406 |
5407 | ##### Measurements
5408 | Group Id: OG000
5409 | Value: 0
5410 | Lower Limit: 0
5411 | Upper Limit: 1
5412 |
5413 | ##### Measurements
5414 | Group Id: OG001
5415 | Value: 0
5416 | Lower Limit: 0
5417 | Upper Limit: 1
5418 |
5419 | ##### Classes
5420 | Title: Hospitalized, on invasive mech. vent. or ECMO
5421 |
5422 | ##### Categories
5423 |
5424 | ##### Measurements
5425 | Group Id: OG000
5426 | Value: 30
5427 | Lower Limit: 26
5428 | Upper Limit: 34
5429 |
5430 | ##### Measurements
5431 | Group Id: OG001
5432 | Value: 24
5433 | Lower Limit: 21
5434 | Upper Limit: 28
5435 |
5436 | ##### Classes
5437 | Title: Hospitalized, on non-invasive vent./high flow O2
5438 |
5439 | ##### Categories
5440 |
5441 | ##### Measurements
5442 | Group Id: OG000
5443 | Value: 19
5444 | Lower Limit: 16
5445 | Upper Limit: 22
5446 |
5447 | ##### Measurements
5448 | Group Id: OG001
5449 | Value: 18
5450 | Lower Limit: 15
5451 | Upper Limit: 21
5452 |
5453 | ##### Classes
5454 | Title: Hospitalized, requiring supplemental oxygen
5455 |
5456 | ##### Categories
5457 |
5458 | ##### Measurements
5459 | Group Id: OG000
5460 | Value: 39
5461 | Lower Limit: 35
5462 | Upper Limit: 43
5463 |
5464 | ##### Measurements
5465 | Group Id: OG001
5466 | Value: 43
5467 | Lower Limit: 39
5468 | Upper Limit: 47
5469 |
5470 | ##### Classes
5471 | Title: Hospitalized, not on O2, requiring ongoing care
5472 |
5473 | ##### Categories
5474 |
5475 | ##### Measurements
5476 | Group Id: OG000
5477 | Value: 12
5478 | Lower Limit: 10
5479 | Upper Limit: 15
5480 |
5481 | ##### Measurements
5482 | Group Id: OG001
5483 | Value: 14
5484 | Lower Limit: 11
5485 | Upper Limit: 17
5486 |
5487 | ##### Classes
5488 | Title: Hospitalized, not requiring O2, no longer req care
5489 |
5490 | ##### Categories
5491 |
5492 | ##### Measurements
5493 | Group Id: OG000
5494 | Value: 0
5495 | Lower Limit: 0
5496 | Upper Limit: 1
5497 |
5498 | ##### Measurements
5499 | Group Id: OG001
5500 | Value: 0
5501 | Lower Limit: 0
5502 | Upper Limit: 1
5503 |
5504 | ##### Classes
5505 | Title: Not hospitalized, limit on activities/req home O2
5506 |
5507 | ##### Categories
5508 |
5509 | ##### Measurements
5510 | Group Id: OG000
5511 | Value: 0
5512 | Lower Limit: 0
5513 | Upper Limit: 1
5514 |
5515 | ##### Measurements
5516 | Group Id: OG001
5517 | Value: 0
5518 | Lower Limit: 0
5519 | Upper Limit: 1
5520 |
5521 | ##### Classes
5522 | Title: Not hospitalized, no limitations on activities
5523 |
5524 | ##### Categories
5525 |
5526 | ##### Measurements
5527 | Group Id: OG000
5528 | Value: 0
5529 | Lower Limit: 0
5530 | Upper Limit: 1
5531 |
5532 | ##### Measurements
5533 | Group Id: OG001
5534 | Value: 0
5535 | Lower Limit: 0
5536 | Upper Limit: 1
5537 |
5538 | ##### Classes
5539 | Title: No clinical status score reported - Hospitalized
5540 |
5541 | ##### Categories
5542 |
5543 | ##### Measurements
5544 | Group Id: OG000
5545 | Value: 0
5546 | Lower Limit: 0
5547 | Upper Limit: 1
5548 |
5549 | ##### Measurements
5550 | Group Id: OG001
5551 | Value: 1
5552 | Lower Limit: 0
5553 | Upper Limit: 2
5554 |
5555 | ##### Classes
5556 | Title: No clinical status score reported - Discharged
5557 |
5558 | ##### Categories
5559 |
5560 | ##### Measurements
5561 | Group Id: OG000
5562 | Value: 0
5563 | Lower Limit: 0
5564 | Upper Limit: 1
5565 |
5566 | ##### Measurements
5567 | Group Id: OG001
5568 | Value: 0
5569 | Lower Limit: 0
5570 | Upper Limit: 1
5571 |
5572 | ##### Classes
5573 | Title: No clinical status score reported - Discontinued
5574 |
5575 | ##### Categories
5576 |
5577 | ##### Measurements
5578 | Group Id: OG000
5579 | Value: 1
5580 | Lower Limit: 0
5581 | Upper Limit: 2
5582 |
5583 | ##### Measurements
5584 | Group Id: OG001
5585 | Value: 1
5586 | Lower Limit: 0
5587 | Upper Limit: 2
5588 |
5589 | #### Outcome Measures
5590 | Type: SECONDARY
5591 | Title:
5592 | Percentage of Participants at Each Clinical Status Using Ordinal Scale
5593 | at Day 3
5594 | Description:
5595 | The ordinal scale is an assessment of the clinical status at the first
5596 | assessment of a given study day. The scale is as follows: 8) Death; 7)
5597 | Hospitalized, on invasive mechanical ventilation or extracorporeal
5598 | membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
5599 | ventilation or high flow oxygen devices; 5) Hospitalized, requiring
5600 | supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
5601 | - requiring ongoing medical care (COVID-19 related or otherwise); 3)
5602 | Hospitalized, not requiring supplemental oxygen - no longer requires
5603 | ongoing medical care; 2) Not hospitalized, limitation on activities
5604 | and/or requiring home oxygen; 1) Not hospitalized, no limitations on
5605 | activities.
5606 | Population Description:
5607 | The intent-to-treat (ITT) population includes all participants who were
5608 | randomized
5609 | Reporting Status: POSTED
5610 | Param Type: NUMBER
5611 | Dispersion Type: 95% Confidence Interval
5612 | Unit Of Measure: percentage of participants
5613 | Time Frame: Day 3
5614 |
5615 | ##### Groups
5616 | Id: OG000
5617 | Title: Placebo
5618 | Description:
5619 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
5620 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
5621 | while hospitalized for up to a 10 days total course.
5622 |
5623 | ##### Groups
5624 | Id: OG001
5625 | Title: Remdesivir
5626 | Description:
5627 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
5628 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
5629 | up to a 10 days total course.
5630 |
5631 | ##### Denoms
5632 | Units: Participants
5633 |
5634 | ##### Counts
5635 | Group Id: OG000
5636 | Value: 521
5637 |
5638 | ##### Counts
5639 | Group Id: OG001
5640 | Value: 541
5641 |
5642 | ##### Classes
5643 | Title: Death at or before study Visit
5644 |
5645 | ##### Categories
5646 |
5647 | ##### Measurements
5648 | Group Id: OG000
5649 | Value: 1
5650 | Lower Limit: 1
5651 | Upper Limit: 3
5652 |
5653 | ##### Measurements
5654 | Group Id: OG001
5655 | Value: 1
5656 | Lower Limit: 0
5657 | Upper Limit: 2
5658 |
5659 | ##### Classes
5660 | Title: Hospitalized, on invasive mech. vent. or ECMO
5661 |
5662 | ##### Categories
5663 |
5664 | ##### Measurements
5665 | Group Id: OG000
5666 | Value: 36
5667 | Lower Limit: 32
5668 | Upper Limit: 40
5669 |
5670 | ##### Measurements
5671 | Group Id: OG001
5672 | Value: 28
5673 | Lower Limit: 25
5674 | Upper Limit: 32
5675 |
5676 | ##### Classes
5677 | Title: Hospitalized, on non-invasive vent./high flow O2
5678 |
5679 | ##### Categories
5680 |
5681 | ##### Measurements
5682 | Group Id: OG000
5683 | Value: 17
5684 | Lower Limit: 14
5685 | Upper Limit: 21
5686 |
5687 | ##### Measurements
5688 | Group Id: OG001
5689 | Value: 16
5690 | Lower Limit: 13
5691 | Upper Limit: 19
5692 |
5693 | ##### Classes
5694 | Title: Hospitalized, requiring supplemental oxygen
5695 |
5696 | ##### Categories
5697 |
5698 | ##### Measurements
5699 | Group Id: OG000
5700 | Value: 32
5701 | Lower Limit: 29
5702 | Upper Limit: 37
5703 |
5704 | ##### Measurements
5705 | Group Id: OG001
5706 | Value: 37
5707 | Lower Limit: 33
5708 | Upper Limit: 41
5709 |
5710 | ##### Classes
5711 | Title: Hospitalized, not on O2, requiring ongoing care
5712 |
5713 | ##### Categories
5714 |
5715 | ##### Measurements
5716 | Group Id: OG000
5717 | Value: 12
5718 | Lower Limit: 9
5719 | Upper Limit: 15
5720 |
5721 | ##### Measurements
5722 | Group Id: OG001
5723 | Value: 13
5724 | Lower Limit: 10
5725 | Upper Limit: 16
5726 |
5727 | ##### Classes
5728 | Title: Hospitalized, not requiring O2, no longer req care
5729 |
5730 | ##### Categories
5731 |
5732 | ##### Measurements
5733 | Group Id: OG000
5734 | Value: 0.4
5735 | Lower Limit: 0
5736 | Upper Limit: 1
5737 |
5738 | ##### Measurements
5739 | Group Id: OG001
5740 | Value: 0.2
5741 | Lower Limit: 0
5742 | Upper Limit: 1
5743 |
5744 | ##### Classes
5745 | Title: Not hospitalized, limit on activities/req home O2
5746 |
5747 | ##### Categories
5748 |
5749 | ##### Measurements
5750 | Group Id: OG000
5751 | Value: 0
5752 | Lower Limit: 0
5753 | Upper Limit: 1
5754 |
5755 | ##### Measurements
5756 | Group Id: OG001
5757 | Value: 0
5758 | Lower Limit: 0
5759 | Upper Limit: 1
5760 |
5761 | ##### Classes
5762 | Title: Not hospitalized, no limitations on activities
5763 |
5764 | ##### Categories
5765 |
5766 | ##### Measurements
5767 | Group Id: OG000
5768 | Value: 0
5769 | Lower Limit: 0
5770 | Upper Limit: 1
5771 |
5772 | ##### Measurements
5773 | Group Id: OG001
5774 | Value: 0.4
5775 | Lower Limit: 0
5776 | Upper Limit: 1
5777 |
5778 | ##### Classes
5779 | Title: No clinical status score reported - Hospitalized
5780 |
5781 | ##### Categories
5782 |
5783 | ##### Measurements
5784 | Group Id: OG000
5785 | Value: 0
5786 | Lower Limit: 0
5787 | Upper Limit: 1
5788 |
5789 | ##### Measurements
5790 | Group Id: OG001
5791 | Value: 0
5792 | Lower Limit: 0
5793 | Upper Limit: 1
5794 |
5795 | ##### Classes
5796 | Title: No clinical status score reported - Discharged
5797 |
5798 | ##### Categories
5799 |
5800 | ##### Measurements
5801 | Group Id: OG000
5802 | Value: 0.2
5803 | Lower Limit: 0
5804 | Upper Limit: 1
5805 |
5806 | ##### Measurements
5807 | Group Id: OG001
5808 | Value: 2
5809 | Lower Limit: 1
5810 | Upper Limit: 4
5811 |
5812 | ##### Classes
5813 | Title: No clinical status score reported - Discontinued
5814 |
5815 | ##### Categories
5816 |
5817 | ##### Measurements
5818 | Group Id: OG000
5819 | Value: 1
5820 | Lower Limit: 0
5821 | Upper Limit: 2
5822 |
5823 | ##### Measurements
5824 | Group Id: OG001
5825 | Value: 2
5826 | Lower Limit: 1
5827 | Upper Limit: 4
5828 |
5829 | #### Outcome Measures
5830 | Type: SECONDARY
5831 | Title:
5832 | Percentage of Participants at Each Clinical Status Using Ordinal Scale
5833 | at Day 5
5834 | Description:
5835 | The ordinal scale is an assessment of the clinical status at the first
5836 | assessment of a given study day. The scale is as follows: 8) Death; 7)
5837 | Hospitalized, on invasive mechanical ventilation or extracorporeal
5838 | membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
5839 | ventilation or high flow oxygen devices; 5) Hospitalized, requiring
5840 | supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
5841 | - requiring ongoing medical care (COVID-19 related or otherwise); 3)
5842 | Hospitalized, not requiring supplemental oxygen - no longer requires
5843 | ongoing medical care; 2) Not hospitalized, limitation on activities
5844 | and/or requiring home oxygen; 1) Not hospitalized, no limitations on
5845 | activities.
5846 | Population Description:
5847 | The intent-to-treat (ITT) population includes all participants who were
5848 | randomized
5849 | Reporting Status: POSTED
5850 | Param Type: NUMBER
5851 | Dispersion Type: 95% Confidence Interval
5852 | Unit Of Measure: percentage of participants
5853 | Time Frame: Day 5
5854 |
5855 | ##### Groups
5856 | Id: OG000
5857 | Title: Placebo
5858 | Description:
5859 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
5860 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
5861 | while hospitalized for up to a 10 days total course.
5862 |
5863 | ##### Groups
5864 | Id: OG001
5865 | Title: Remdesivir
5866 | Description:
5867 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
5868 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
5869 | up to a 10 days total course.
5870 |
5871 | ##### Denoms
5872 | Units: Participants
5873 |
5874 | ##### Counts
5875 | Group Id: OG000
5876 | Value: 521
5877 |
5878 | ##### Counts
5879 | Group Id: OG001
5880 | Value: 541
5881 |
5882 | ##### Classes
5883 | Title: Death at or before study Visit
5884 |
5885 | ##### Categories
5886 |
5887 | ##### Measurements
5888 | Group Id: OG000
5889 | Value: 2
5890 | Lower Limit: 1
5891 | Upper Limit: 4
5892 |
5893 | ##### Measurements
5894 | Group Id: OG001
5895 | Value: 2
5896 | Lower Limit: 1
5897 | Upper Limit: 4
5898 |
5899 | ##### Classes
5900 | Title: Hospitalized, on invasive mech. vent. or ECMO
5901 |
5902 | ##### Categories
5903 |
5904 | ##### Measurements
5905 | Group Id: OG000
5906 | Value: 37
5907 | Lower Limit: 33
5908 | Upper Limit: 41
5909 |
5910 | ##### Measurements
5911 | Group Id: OG001
5912 | Value: 28
5913 | Lower Limit: 24
5914 | Upper Limit: 32
5915 |
5916 | ##### Classes
5917 | Title: Hospitalized, on non-invasive vent./high flow O2
5918 |
5919 | ##### Categories
5920 |
5921 | ##### Measurements
5922 | Group Id: OG000
5923 | Value: 14
5924 | Lower Limit: 12
5925 | Upper Limit: 18
5926 |
5927 | ##### Measurements
5928 | Group Id: OG001
5929 | Value: 12
5930 | Lower Limit: 9
5931 | Upper Limit: 15
5932 |
5933 | ##### Classes
5934 | Title: Hospitalized, requiring supplemental oxygen
5935 |
5936 | ##### Categories
5937 |
5938 | ##### Measurements
5939 | Group Id: OG000
5940 | Value: 26
5941 | Lower Limit: 23
5942 | Upper Limit: 30
5943 |
5944 | ##### Measurements
5945 | Group Id: OG001
5946 | Value: 28
5947 | Lower Limit: 24
5948 | Upper Limit: 31
5949 |
5950 | ##### Classes
5951 | Title: Hospitalized, not on O2, requiring ongoing care
5952 |
5953 | ##### Categories
5954 |
5955 | ##### Measurements
5956 | Group Id: OG000
5957 | Value: 11
5958 | Lower Limit: 8
5959 | Upper Limit: 13
5960 |
5961 | ##### Measurements
5962 | Group Id: OG001
5963 | Value: 15
5964 | Lower Limit: 12
5965 | Upper Limit: 18
5966 |
5967 | ##### Classes
5968 | Title: Hospitalized, not requiring O2, no longer req care
5969 |
5970 | ##### Categories
5971 |
5972 | ##### Measurements
5973 | Group Id: OG000
5974 | Value: 1
5975 | Lower Limit: 0
5976 | Upper Limit: 2
5977 |
5978 | ##### Measurements
5979 | Group Id: OG001
5980 | Value: 1
5981 | Lower Limit: 0
5982 | Upper Limit: 2
5983 |
5984 | ##### Classes
5985 | Title: Not hospitalized, limit on activities/req home O2
5986 |
5987 | ##### Categories
5988 |
5989 | ##### Measurements
5990 | Group Id: OG000
5991 | Value: 0
5992 | Lower Limit: 0
5993 | Upper Limit: 1
5994 |
5995 | ##### Measurements
5996 | Group Id: OG001
5997 | Value: 0.2
5998 | Lower Limit: 0
5999 | Upper Limit: 1
6000 |
6001 | ##### Classes
6002 | Title: Not hospitalized, no limitations on activities
6003 |
6004 | ##### Categories
6005 |
6006 | ##### Measurements
6007 | Group Id: OG000
6008 | Value: 0.2
6009 | Lower Limit: 0
6010 | Upper Limit: 1
6011 |
6012 | ##### Measurements
6013 | Group Id: OG001
6014 | Value: 0
6015 | Lower Limit: 0
6016 | Upper Limit: 1
6017 |
6018 | ##### Classes
6019 | Title: No clinical status score reported - Hospitalized
6020 |
6021 | ##### Categories
6022 |
6023 | ##### Measurements
6024 | Group Id: OG000
6025 | Value: 0
6026 | Lower Limit: 0
6027 | Upper Limit: 1
6028 |
6029 | ##### Measurements
6030 | Group Id: OG001
6031 | Value: 0
6032 | Lower Limit: 0
6033 | Upper Limit: 1
6034 |
6035 | ##### Classes
6036 | Title: No clinical status score reported - Discharged
6037 |
6038 | ##### Categories
6039 |
6040 | ##### Measurements
6041 | Group Id: OG000
6042 | Value: 7
6043 | Lower Limit: 5
6044 | Upper Limit: 9
6045 |
6046 | ##### Measurements
6047 | Group Id: OG001
6048 | Value: 12
6049 | Lower Limit: 9
6050 | Upper Limit: 15
6051 |
6052 | ##### Classes
6053 | Title: No clinical status score reported - Discontinued
6054 |
6055 | ##### Categories
6056 |
6057 | ##### Measurements
6058 | Group Id: OG000
6059 | Value: 2
6060 | Lower Limit: 1
6061 | Upper Limit: 3
6062 |
6063 | ##### Measurements
6064 | Group Id: OG001
6065 | Value: 3
6066 | Lower Limit: 2
6067 | Upper Limit: 5
6068 |
6069 | #### Outcome Measures
6070 | Type: SECONDARY
6071 | Title:
6072 | Percentage of Participants at Each Clinical Status Using Ordinal Scale
6073 | at Day 8
6074 | Description:
6075 | The ordinal scale is an assessment of the clinical status at the first
6076 | assessment of a given study day. The scale is as follows: 8) Death; 7)
6077 | Hospitalized, on invasive mechanical ventilation or extracorporeal
6078 | membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
6079 | ventilation or high flow oxygen devices; 5) Hospitalized, requiring
6080 | supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
6081 | - requiring ongoing medical care (COVID-19 related or otherwise); 3)
6082 | Hospitalized, not requiring supplemental oxygen - no longer requires
6083 | ongoing medical care; 2) Not hospitalized, limitation on activities
6084 | and/or requiring home oxygen; 1) Not hospitalized, no limitations on
6085 | activities.
6086 | Population Description:
6087 | The intent-to-treat (ITT) population includes all participants who were
6088 | randomized
6089 | Reporting Status: POSTED
6090 | Param Type: NUMBER
6091 | Dispersion Type: 95% Confidence Interval
6092 | Unit Of Measure: percentage of participants
6093 | Time Frame: Day 8
6094 |
6095 | ##### Groups
6096 | Id: OG000
6097 | Title: Placebo
6098 | Description:
6099 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
6100 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
6101 | while hospitalized for up to a 10 days total course.
6102 |
6103 | ##### Groups
6104 | Id: OG001
6105 | Title: Remdesivir
6106 | Description:
6107 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
6108 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
6109 | up to a 10 days total course.
6110 |
6111 | ##### Denoms
6112 | Units: Participants
6113 |
6114 | ##### Counts
6115 | Group Id: OG000
6116 | Value: 521
6117 |
6118 | ##### Counts
6119 | Group Id: OG001
6120 | Value: 541
6121 |
6122 | ##### Classes
6123 | Title: Death at or before study Visit
6124 |
6125 | ##### Categories
6126 |
6127 | ##### Measurements
6128 | Group Id: OG000
6129 | Value: 7
6130 | Lower Limit: 5
6131 | Upper Limit: 9
6132 |
6133 | ##### Measurements
6134 | Group Id: OG001
6135 | Value: 3
6136 | Lower Limit: 2
6137 | Upper Limit: 5
6138 |
6139 | ##### Classes
6140 | Title: Hospitalized, on invasive mech. vent. or ECMO
6141 |
6142 | ##### Categories
6143 |
6144 | ##### Measurements
6145 | Group Id: OG000
6146 | Value: 33
6147 | Lower Limit: 29
6148 | Upper Limit: 37
6149 |
6150 | ##### Measurements
6151 | Group Id: OG001
6152 | Value: 24
6153 | Lower Limit: 21
6154 | Upper Limit: 28
6155 |
6156 | ##### Classes
6157 | Title: Hospitalized, on non-invasive vent./high flow O2
6158 |
6159 | ##### Categories
6160 |
6161 | ##### Measurements
6162 | Group Id: OG000
6163 | Value: 9
6164 | Lower Limit: 7
6165 | Upper Limit: 12
6166 |
6167 | ##### Measurements
6168 | Group Id: OG001
6169 | Value: 9
6170 | Lower Limit: 7
6171 | Upper Limit: 12
6172 |
6173 | ##### Classes
6174 | Title: Hospitalized, requiring supplemental oxygen
6175 |
6176 | ##### Categories
6177 |
6178 | ##### Measurements
6179 | Group Id: OG000
6180 | Value: 15
6181 | Lower Limit: 13
6182 | Upper Limit: 19
6183 |
6184 | ##### Measurements
6185 | Group Id: OG001
6186 | Value: 17
6187 | Lower Limit: 14
6188 | Upper Limit: 21
6189 |
6190 | ##### Classes
6191 | Title: Hospitalized, not on O2, requiring ongoing care
6192 |
6193 | ##### Categories
6194 |
6195 | ##### Measurements
6196 | Group Id: OG000
6197 | Value: 10
6198 | Lower Limit: 8
6199 | Upper Limit: 13
6200 |
6201 | ##### Measurements
6202 | Group Id: OG001
6203 | Value: 11
6204 | Lower Limit: 9
6205 | Upper Limit: 14
6206 |
6207 | ##### Classes
6208 | Title: Hospitalized, not requiring O2, no longer req care
6209 |
6210 | ##### Categories
6211 |
6212 | ##### Measurements
6213 | Group Id: OG000
6214 | Value: 1
6215 | Lower Limit: 1
6216 | Upper Limit: 3
6217 |
6218 | ##### Measurements
6219 | Group Id: OG001
6220 | Value: 1
6221 | Lower Limit: 1
6222 | Upper Limit: 3
6223 |
6224 | ##### Classes
6225 | Title: Not hospitalized, limit on activities/req home O2
6226 |
6227 | ##### Categories
6228 |
6229 | ##### Measurements
6230 | Group Id: OG000
6231 | Value: 0
6232 | Lower Limit: 0
6233 | Upper Limit: 1
6234 |
6235 | ##### Measurements
6236 | Group Id: OG001
6237 | Value: 0.2
6238 | Lower Limit: 0
6239 | Upper Limit: 1
6240 |
6241 | ##### Classes
6242 | Title: Not hospitalized, no limitations on activities
6243 |
6244 | ##### Categories
6245 |
6246 | ##### Measurements
6247 | Group Id: OG000
6248 | Value: 0.2
6249 | Lower Limit: 0
6250 | Upper Limit: 1
6251 |
6252 | ##### Measurements
6253 | Group Id: OG001
6254 | Value: 0
6255 | Lower Limit: 0
6256 | Upper Limit: 1
6257 |
6258 | ##### Classes
6259 | Title: No clinical status score reported - Hospitalized
6260 |
6261 | ##### Categories
6262 |
6263 | ##### Measurements
6264 | Group Id: OG000
6265 | Value: 0
6266 | Lower Limit: 0
6267 | Upper Limit: 1
6268 |
6269 | ##### Measurements
6270 | Group Id: OG001
6271 | Value: 0.4
6272 | Lower Limit: 0
6273 | Upper Limit: 1
6274 |
6275 | ##### Classes
6276 | Title: No clinical status score reported - Discharged
6277 |
6278 | ##### Categories
6279 |
6280 | ##### Measurements
6281 | Group Id: OG000
6282 | Value: 22
6283 | Lower Limit: 19
6284 | Upper Limit: 26
6285 |
6286 | ##### Measurements
6287 | Group Id: OG001
6288 | Value: 30
6289 | Lower Limit: 27
6290 | Upper Limit: 34
6291 |
6292 | ##### Classes
6293 | Title: No clinical status score reported - Discontinued
6294 |
6295 | ##### Categories
6296 |
6297 | ##### Measurements
6298 | Group Id: OG000
6299 | Value: 2
6300 | Lower Limit: 1
6301 | Upper Limit: 3
6302 |
6303 | ##### Measurements
6304 | Group Id: OG001
6305 | Value: 4
6306 | Lower Limit: 2
6307 | Upper Limit: 5
6308 |
6309 | #### Outcome Measures
6310 | Type: SECONDARY
6311 | Title:
6312 | Percentage of Participants at Each Clinical Status Using Ordinal Scale
6313 | at Day 11
6314 | Description:
6315 | The ordinal scale is an assessment of the clinical status at the first
6316 | assessment of a given study day. The scale is as follows: 8) Death; 7)
6317 | Hospitalized, on invasive mechanical ventilation or extracorporeal
6318 | membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
6319 | ventilation or high flow oxygen devices; 5) Hospitalized, requiring
6320 | supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
6321 | - requiring ongoing medical care (COVID-19 related or otherwise); 3)
6322 | Hospitalized, not requiring supplemental oxygen - no longer requires
6323 | ongoing medical care; 2) Not hospitalized, limitation on activities
6324 | and/or requiring home oxygen; 1) Not hospitalized, no limitations on
6325 | activities.
6326 | Population Description:
6327 | The intent-to-treat (ITT) population includes all participants who were
6328 | randomized
6329 | Reporting Status: POSTED
6330 | Param Type: NUMBER
6331 | Dispersion Type: 95% Confidence Interval
6332 | Unit Of Measure: percentage of participants
6333 | Time Frame: Day 11
6334 |
6335 | ##### Groups
6336 | Id: OG000
6337 | Title: Placebo
6338 | Description:
6339 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
6340 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
6341 | while hospitalized for up to a 10 days total course.
6342 |
6343 | ##### Groups
6344 | Id: OG001
6345 | Title: Remdesivir
6346 | Description:
6347 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
6348 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
6349 | up to a 10 days total course.
6350 |
6351 | ##### Denoms
6352 | Units: Participants
6353 |
6354 | ##### Counts
6355 | Group Id: OG000
6356 | Value: 521
6357 |
6358 | ##### Counts
6359 | Group Id: OG001
6360 | Value: 541
6361 |
6362 | ##### Classes
6363 | Title: Death at or before study Visit
6364 |
6365 | ##### Categories
6366 |
6367 | ##### Measurements
6368 | Group Id: OG000
6369 | Value: 8
6370 | Lower Limit: 6
6371 | Upper Limit: 11
6372 |
6373 | ##### Measurements
6374 | Group Id: OG001
6375 | Value: 4
6376 | Lower Limit: 3
6377 | Upper Limit: 6
6378 |
6379 | ##### Classes
6380 | Title: Hospitalized, on invasive mech. vent. or ECMO
6381 |
6382 | ##### Categories
6383 |
6384 | ##### Measurements
6385 | Group Id: OG000
6386 | Value: 28
6387 | Lower Limit: 25
6388 | Upper Limit: 32
6389 |
6390 | ##### Measurements
6391 | Group Id: OG001
6392 | Value: 22
6393 | Lower Limit: 19
6394 | Upper Limit: 26
6395 |
6396 | ##### Classes
6397 | Title: Hospitalized, on non-invasive vent./high flow O2
6398 |
6399 | ##### Categories
6400 |
6401 | ##### Measurements
6402 | Group Id: OG000
6403 | Value: 7
6404 | Lower Limit: 5
6405 | Upper Limit: 10
6406 |
6407 | ##### Measurements
6408 | Group Id: OG001
6409 | Value: 6
6410 | Lower Limit: 4
6411 | Upper Limit: 8
6412 |
6413 | ##### Classes
6414 | Title: Hospitalized, requiring supplemental oxygen
6415 |
6416 | ##### Categories
6417 |
6418 | ##### Measurements
6419 | Group Id: OG000
6420 | Value: 13
6421 | Lower Limit: 10
6422 | Upper Limit: 16
6423 |
6424 | ##### Measurements
6425 | Group Id: OG001
6426 | Value: 11
6427 | Lower Limit: 9
6428 | Upper Limit: 14
6429 |
6430 | ##### Classes
6431 | Title: Hospitalized, not on O2, requiring ongoing care
6432 |
6433 | ##### Categories
6434 |
6435 | ##### Measurements
6436 | Group Id: OG000
6437 | Value: 6
6438 | Lower Limit: 5
6439 | Upper Limit: 9
6440 |
6441 | ##### Measurements
6442 | Group Id: OG001
6443 | Value: 7
6444 | Lower Limit: 5
6445 | Upper Limit: 9
6446 |
6447 | ##### Classes
6448 | Title: Hospitalized, not requiring O2, no longer req care
6449 |
6450 | ##### Categories
6451 |
6452 | ##### Measurements
6453 | Group Id: OG000
6454 | Value: 2
6455 | Lower Limit: 1
6456 | Upper Limit: 4
6457 |
6458 | ##### Measurements
6459 | Group Id: OG001
6460 | Value: 2
6461 | Lower Limit: 1
6462 | Upper Limit: 4
6463 |
6464 | ##### Classes
6465 | Title: Not hospitalized, limit on activities/req home O2
6466 |
6467 | ##### Categories
6468 |
6469 | ##### Measurements
6470 | Group Id: OG000
6471 | Value: 0.4
6472 | Lower Limit: 0
6473 | Upper Limit: 1
6474 |
6475 | ##### Measurements
6476 | Group Id: OG001
6477 | Value: 0.4
6478 | Lower Limit: 0
6479 | Upper Limit: 1
6480 |
6481 | ##### Classes
6482 | Title: Not hospitalized, no limitations on activities
6483 |
6484 | ##### Categories
6485 |
6486 | ##### Measurements
6487 | Group Id: OG000
6488 | Value: 0.2
6489 | Lower Limit: 0
6490 | Upper Limit: 1
6491 |
6492 | ##### Measurements
6493 | Group Id: OG001
6494 | Value: 0
6495 | Lower Limit: 0
6496 | Upper Limit: 1
6497 |
6498 | ##### Classes
6499 | Title: No clinical status score reported - Hospitalized
6500 |
6501 | ##### Categories
6502 |
6503 | ##### Measurements
6504 | Group Id: OG000
6505 | Value: 0
6506 | Lower Limit: 0
6507 | Upper Limit: 1
6508 |
6509 | ##### Measurements
6510 | Group Id: OG001
6511 | Value: 0
6512 | Lower Limit: 0
6513 | Upper Limit: 1
6514 |
6515 | ##### Classes
6516 | Title: No clinical status score reported - Discharged
6517 |
6518 | ##### Categories
6519 |
6520 | ##### Measurements
6521 | Group Id: OG000
6522 | Value: 33
6523 | Lower Limit: 29
6524 | Upper Limit: 37
6525 |
6526 | ##### Measurements
6527 | Group Id: OG001
6528 | Value: 44
6529 | Lower Limit: 40
6530 | Upper Limit: 48
6531 |
6532 | ##### Classes
6533 | Title: No clinical status score reported - Discontinued
6534 |
6535 | ##### Categories
6536 |
6537 | ##### Measurements
6538 | Group Id: OG000
6539 | Value: 2
6540 | Lower Limit: 1
6541 | Upper Limit: 4
6542 |
6543 | ##### Measurements
6544 | Group Id: OG001
6545 | Value: 4
6546 | Lower Limit: 3
6547 | Upper Limit: 6
6548 |
6549 | #### Outcome Measures
6550 | Type: SECONDARY
6551 | Title:
6552 | Percentage of Participants at Each Clinical Status Using Ordinal Scale
6553 | at Day 15
6554 | Description:
6555 | The ordinal scale is an assessment of the clinical status at the first
6556 | assessment of a given study day. The scale is as follows: 8) Death; 7)
6557 | Hospitalized, on invasive mechanical ventilation or extracorporeal
6558 | membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
6559 | ventilation or high flow oxygen devices; 5) Hospitalized, requiring
6560 | supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
6561 | - requiring ongoing medical care (COVID-19 related or otherwise); 3)
6562 | Hospitalized, not requiring supplemental oxygen - no longer requires
6563 | ongoing medical care; 2) Not hospitalized, limitation on activities
6564 | and/or requiring home oxygen; 1) Not hospitalized, no limitations on
6565 | activities.
6566 | Population Description:
6567 | The intent-to-treat (ITT) population includes all participants who were
6568 | randomized
6569 | Reporting Status: POSTED
6570 | Param Type: NUMBER
6571 | Dispersion Type: 95% Confidence Interval
6572 | Unit Of Measure: percentage of participants
6573 | Time Frame: Day 15
6574 |
6575 | ##### Groups
6576 | Id: OG000
6577 | Title: Placebo
6578 | Description:
6579 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
6580 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
6581 | while hospitalized for up to a 10 days total course.
6582 |
6583 | ##### Groups
6584 | Id: OG001
6585 | Title: Remdesivir
6586 | Description:
6587 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
6588 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
6589 | up to a 10 days total course.
6590 |
6591 | ##### Denoms
6592 | Units: Participants
6593 |
6594 | ##### Counts
6595 | Group Id: OG000
6596 | Value: 521
6597 |
6598 | ##### Counts
6599 | Group Id: OG001
6600 | Value: 541
6601 |
6602 | ##### Classes
6603 | Title: Death at or before study Visit
6604 |
6605 | ##### Categories
6606 |
6607 | ##### Measurements
6608 | Group Id: OG000
6609 | Value: 11
6610 | Lower Limit: 9
6611 | Upper Limit: 14
6612 |
6613 | ##### Measurements
6614 | Group Id: OG001
6615 | Value: 6
6616 | Lower Limit: 5
6617 | Upper Limit: 9
6618 |
6619 | ##### Classes
6620 | Title: Hospitalized, on invasive mech. vent. or ECMO
6621 |
6622 | ##### Categories
6623 |
6624 | ##### Measurements
6625 | Group Id: OG000
6626 | Value: 22
6627 | Lower Limit: 19
6628 | Upper Limit: 26
6629 |
6630 | ##### Measurements
6631 | Group Id: OG001
6632 | Value: 15
6633 | Lower Limit: 13
6634 | Upper Limit: 19
6635 |
6636 | ##### Classes
6637 | Title: Hospitalized, on non-invasive vent./high flow O2
6638 |
6639 | ##### Categories
6640 |
6641 | ##### Measurements
6642 | Group Id: OG000
6643 | Value: 4
6644 | Lower Limit: 3
6645 | Upper Limit: 6
6646 |
6647 | ##### Measurements
6648 | Group Id: OG001
6649 | Value: 4
6650 | Lower Limit: 3
6651 | Upper Limit: 6
6652 |
6653 | ##### Classes
6654 | Title: Hospitalized, requiring supplemental oxygen
6655 |
6656 | ##### Categories
6657 |
6658 | ##### Measurements
6659 | Group Id: OG000
6660 | Value: 11
6661 | Lower Limit: 9
6662 | Upper Limit: 14
6663 |
6664 | ##### Measurements
6665 | Group Id: OG001
6666 | Value: 10
6667 | Lower Limit: 8
6668 | Upper Limit: 13
6669 |
6670 | ##### Classes
6671 | Title: Hospitalized, not on O2, requiring ongoing care
6672 |
6673 | ##### Categories
6674 |
6675 | ##### Measurements
6676 | Group Id: OG000
6677 | Value: 6
6678 | Lower Limit: 5
6679 | Upper Limit: 9
6680 |
6681 | ##### Measurements
6682 | Group Id: OG001
6683 | Value: 7
6684 | Lower Limit: 5
6685 | Upper Limit: 9
6686 |
6687 | ##### Classes
6688 | Title: Hospitalized, not requiring O2, no longer req care
6689 |
6690 | ##### Categories
6691 |
6692 | ##### Measurements
6693 | Group Id: OG000
6694 | Value: 2
6695 | Lower Limit: 1
6696 | Upper Limit: 3
6697 |
6698 | ##### Measurements
6699 | Group Id: OG001
6700 | Value: 3
6701 | Lower Limit: 2
6702 | Upper Limit: 4
6703 |
6704 | ##### Classes
6705 | Title: Not hospitalized, limit on activities/req home O2
6706 |
6707 | ##### Categories
6708 |
6709 | ##### Measurements
6710 | Group Id: OG000
6711 | Value: 17
6712 | Lower Limit: 14
6713 | Upper Limit: 21
6714 |
6715 | ##### Measurements
6716 | Group Id: OG001
6717 | Value: 19
6718 | Lower Limit: 16
6719 | Upper Limit: 22
6720 |
6721 | ##### Classes
6722 | Title: Not hospitalized, no limitations on activities
6723 |
6724 | ##### Categories
6725 |
6726 | ##### Measurements
6727 | Group Id: OG000
6728 | Value: 22
6729 | Lower Limit: 19
6730 | Upper Limit: 26
6731 |
6732 | ##### Measurements
6733 | Group Id: OG001
6734 | Value: 29
6735 | Lower Limit: 25
6736 | Upper Limit: 33
6737 |
6738 | ##### Classes
6739 | Title: No clinical status score reported - Hospitalized
6740 |
6741 | ##### Categories
6742 |
6743 | ##### Measurements
6744 | Group Id: OG000
6745 | Value: 0
6746 | Lower Limit: 0
6747 | Upper Limit: 1
6748 |
6749 | ##### Measurements
6750 | Group Id: OG001
6751 | Value: 0
6752 | Lower Limit: 0
6753 | Upper Limit: 1
6754 |
6755 | ##### Classes
6756 | Title: No clinical status score reported - Discharged
6757 |
6758 | ##### Categories
6759 |
6760 | ##### Measurements
6761 | Group Id: OG000
6762 | Value: 2
6763 | Lower Limit: 1
6764 | Upper Limit: 3
6765 |
6766 | ##### Measurements
6767 | Group Id: OG001
6768 | Value: 2
6769 | Lower Limit: 1
6770 | Upper Limit: 4
6771 |
6772 | ##### Classes
6773 | Title: No clinical status score reported - Discontinued
6774 |
6775 | ##### Categories
6776 |
6777 | ##### Measurements
6778 | Group Id: OG000
6779 | Value: 3
6780 | Lower Limit: 2
6781 | Upper Limit: 4
6782 |
6783 | ##### Measurements
6784 | Group Id: OG001
6785 | Value: 5
6786 | Lower Limit: 3
6787 | Upper Limit: 7
6788 |
6789 | #### Outcome Measures
6790 | Type: SECONDARY
6791 | Title:
6792 | Percentage of Participants at Each Clinical Status Using Ordinal Scale
6793 | at Day 22
6794 | Description:
6795 | The ordinal scale is an assessment of the clinical status at the first
6796 | assessment of a given study day. The scale is as follows: 8) Death; 7)
6797 | Hospitalized, on invasive mechanical ventilation or extracorporeal
6798 | membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
6799 | ventilation or high flow oxygen devices; 5) Hospitalized, requiring
6800 | supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
6801 | - requiring ongoing medical care (COVID-19 related or otherwise); 3)
6802 | Hospitalized, not requiring supplemental oxygen - no longer requires
6803 | ongoing medical care; 2) Not hospitalized, limitation on activities
6804 | and/or requiring home oxygen; 1) Not hospitalized, no limitations on
6805 | activities.
6806 | Population Description:
6807 | The intent-to-treat (ITT) population includes all participants who were
6808 | randomized
6809 | Reporting Status: POSTED
6810 | Param Type: NUMBER
6811 | Dispersion Type: 95% Confidence Interval
6812 | Unit Of Measure: percentage of participants
6813 | Time Frame: Day 22
6814 |
6815 | ##### Groups
6816 | Id: OG000
6817 | Title: Placebo
6818 | Description:
6819 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
6820 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
6821 | while hospitalized for up to a 10 days total course.
6822 |
6823 | ##### Groups
6824 | Id: OG001
6825 | Title: Remdesivir
6826 | Description:
6827 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
6828 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
6829 | up to a 10 days total course.
6830 |
6831 | ##### Denoms
6832 | Units: Participants
6833 |
6834 | ##### Counts
6835 | Group Id: OG000
6836 | Value: 521
6837 |
6838 | ##### Counts
6839 | Group Id: OG001
6840 | Value: 541
6841 |
6842 | ##### Classes
6843 | Title: Death at or before study Visit
6844 |
6845 | ##### Categories
6846 |
6847 | ##### Measurements
6848 | Group Id: OG000
6849 | Value: 13
6850 | Lower Limit: 10
6851 | Upper Limit: 16
6852 |
6853 | ##### Measurements
6854 | Group Id: OG001
6855 | Value: 9
6856 | Lower Limit: 7
6857 | Upper Limit: 12
6858 |
6859 | ##### Classes
6860 | Title: Hospitalized, on invasive mech. vent. or ECMO
6861 |
6862 | ##### Categories
6863 |
6864 | ##### Measurements
6865 | Group Id: OG000
6866 | Value: 14
6867 | Lower Limit: 12
6868 | Upper Limit: 18
6869 |
6870 | ##### Measurements
6871 | Group Id: OG001
6872 | Value: 9
6873 | Lower Limit: 7
6874 | Upper Limit: 12
6875 |
6876 | ##### Classes
6877 | Title: Hospitalized, on non-invasive vent./high flow O2
6878 |
6879 | ##### Categories
6880 |
6881 | ##### Measurements
6882 | Group Id: OG000
6883 | Value: 2
6884 | Lower Limit: 1
6885 | Upper Limit: 4
6886 |
6887 | ##### Measurements
6888 | Group Id: OG001
6889 | Value: 2
6890 | Lower Limit: 1
6891 | Upper Limit: 4
6892 |
6893 | ##### Classes
6894 | Title: Hospitalized, requiring supplemental oxygen
6895 |
6896 | ##### Categories
6897 |
6898 | ##### Measurements
6899 | Group Id: OG000
6900 | Value: 8
6901 | Lower Limit: 6
6902 | Upper Limit: 11
6903 |
6904 | ##### Measurements
6905 | Group Id: OG001
6906 | Value: 5
6907 | Lower Limit: 4
6908 | Upper Limit: 8
6909 |
6910 | ##### Classes
6911 | Title: Hospitalized, not on O2, requiring ongoing care
6912 |
6913 | ##### Categories
6914 |
6915 | ##### Measurements
6916 | Group Id: OG000
6917 | Value: 5
6918 | Lower Limit: 4
6919 | Upper Limit: 8
6920 |
6921 | ##### Measurements
6922 | Group Id: OG001
6923 | Value: 6
6924 | Lower Limit: 4
6925 | Upper Limit: 8
6926 |
6927 | ##### Classes
6928 | Title: Hospitalized, not requiring O2, no longer req care
6929 |
6930 | ##### Categories
6931 |
6932 | ##### Measurements
6933 | Group Id: OG000
6934 | Value: 1
6935 | Lower Limit: 0
6936 | Upper Limit: 2
6937 |
6938 | ##### Measurements
6939 | Group Id: OG001
6940 | Value: 1
6941 | Lower Limit: 1
6942 | Upper Limit: 3
6943 |
6944 | ##### Classes
6945 | Title: Not hospitalized, limit on activities/req home O2
6946 |
6947 | ##### Categories
6948 |
6949 | ##### Measurements
6950 | Group Id: OG000
6951 | Value: 18
6952 | Lower Limit: 15
6953 | Upper Limit: 22
6954 |
6955 | ##### Measurements
6956 | Group Id: OG001
6957 | Value: 19
6958 | Lower Limit: 16
6959 | Upper Limit: 23
6960 |
6961 | ##### Classes
6962 | Title: Not hospitalized, no limitations on activities
6963 |
6964 | ##### Categories
6965 |
6966 | ##### Measurements
6967 | Group Id: OG000
6968 | Value: 32
6969 | Lower Limit: 29
6970 | Upper Limit: 37
6971 |
6972 | ##### Measurements
6973 | Group Id: OG001
6974 | Value: 39
6975 | Lower Limit: 35
6976 | Upper Limit: 43
6977 |
6978 | ##### Classes
6979 | Title: No clinical status score reported - Hospitalized
6980 |
6981 | ##### Categories
6982 |
6983 | ##### Measurements
6984 | Group Id: OG000
6985 | Value: 0
6986 | Lower Limit: 0
6987 | Upper Limit: 1
6988 |
6989 | ##### Measurements
6990 | Group Id: OG001
6991 | Value: 0
6992 | Lower Limit: 0
6993 | Upper Limit: 1
6994 |
6995 | ##### Classes
6996 | Title: No clinical status score reported - Discharged
6997 |
6998 | ##### Categories
6999 |
7000 | ##### Measurements
7001 | Group Id: OG000
7002 | Value: 2
7003 | Lower Limit: 1
7004 | Upper Limit: 4
7005 |
7006 | ##### Measurements
7007 | Group Id: OG001
7008 | Value: 3
7009 | Lower Limit: 2
7010 | Upper Limit: 5
7011 |
7012 | ##### Classes
7013 | Title: No clinical status score reported - Discontinued
7014 |
7015 | ##### Categories
7016 |
7017 | ##### Measurements
7018 | Group Id: OG000
7019 | Value: 4
7020 | Lower Limit: 2
7021 | Upper Limit: 6
7022 |
7023 | ##### Measurements
7024 | Group Id: OG001
7025 | Value: 6
7026 | Lower Limit: 4
7027 | Upper Limit: 8
7028 |
7029 | ##### Classes
7030 | Title: Completed study without reporting score
7031 |
7032 | ##### Categories
7033 |
7034 | ##### Measurements
7035 | Group Id: OG000
7036 | Value: 0
7037 | Lower Limit: 0
7038 | Upper Limit: 1
7039 |
7040 | ##### Measurements
7041 | Group Id: OG001
7042 | Value: 0.2
7043 | Lower Limit: 0
7044 | Upper Limit: 1
7045 |
7046 | #### Outcome Measures
7047 | Type: SECONDARY
7048 | Title:
7049 | Percentage of Participants at Each Clinical Status Using Ordinal Scale
7050 | at Day 29
7051 | Description:
7052 | The ordinal scale is an assessment of the clinical status at the first
7053 | assessment of a given study day. The scale is as follows: 8) Death; 7)
7054 | Hospitalized, on invasive mechanical ventilation or extracorporeal
7055 | membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
7056 | ventilation or high flow oxygen devices; 5) Hospitalized, requiring
7057 | supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
7058 | - requiring ongoing medical care (COVID-19 related or otherwise); 3)
7059 | Hospitalized, not requiring supplemental oxygen - no longer requires
7060 | ongoing medical care; 2) Not hospitalized, limitation on activities
7061 | and/or requiring home oxygen; 1) Not hospitalized, no limitations on
7062 | activities.
7063 | Population Description:
7064 | The intent-to-treat (ITT) population includes all participants who were
7065 | randomized
7066 | Reporting Status: POSTED
7067 | Param Type: NUMBER
7068 | Dispersion Type: 95% Confidence Interval
7069 | Unit Of Measure: percentage of participants
7070 | Time Frame: Day 29
7071 |
7072 | ##### Groups
7073 | Id: OG000
7074 | Title: Placebo
7075 | Description:
7076 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
7077 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
7078 | while hospitalized for up to a 10 days total course.
7079 |
7080 | ##### Groups
7081 | Id: OG001
7082 | Title: Remdesivir
7083 | Description:
7084 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
7085 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
7086 | up to a 10 days total course.
7087 |
7088 | ##### Denoms
7089 | Units: Participants
7090 |
7091 | ##### Counts
7092 | Group Id: OG000
7093 | Value: 521
7094 |
7095 | ##### Counts
7096 | Group Id: OG001
7097 | Value: 541
7098 |
7099 | ##### Classes
7100 | Title: Death at or before study Visit
7101 |
7102 | ##### Categories
7103 |
7104 | ##### Measurements
7105 | Group Id: OG000
7106 | Value: 15
7107 | Lower Limit: 12
7108 | Upper Limit: 18
7109 |
7110 | ##### Measurements
7111 | Group Id: OG001
7112 | Value: 11
7113 | Lower Limit: 8
7114 | Upper Limit: 14
7115 |
7116 | ##### Classes
7117 | Title: Hospitalized, on invasive mech. vent. or ECMO
7118 |
7119 | ##### Categories
7120 |
7121 | ##### Measurements
7122 | Group Id: OG000
7123 | Value: 9
7124 | Lower Limit: 7
7125 | Upper Limit: 11
7126 |
7127 | ##### Measurements
7128 | Group Id: OG001
7129 | Value: 6
7130 | Lower Limit: 4
7131 | Upper Limit: 8
7132 |
7133 | ##### Classes
7134 | Title: Hospitalized, on non-invasive vent./high flow O2
7135 |
7136 | ##### Categories
7137 |
7138 | ##### Measurements
7139 | Group Id: OG000
7140 | Value: 2
7141 | Lower Limit: 1
7142 | Upper Limit: 3
7143 |
7144 | ##### Measurements
7145 | Group Id: OG001
7146 | Value: 1
7147 | Lower Limit: 0
7148 | Upper Limit: 2
7149 |
7150 | ##### Classes
7151 | Title: Hospitalized, requiring supplemental oxygen
7152 |
7153 | ##### Categories
7154 |
7155 | ##### Measurements
7156 | Group Id: OG000
7157 | Value: 4
7158 | Lower Limit: 3
7159 | Upper Limit: 6
7160 |
7161 | ##### Measurements
7162 | Group Id: OG001
7163 | Value: 4
7164 | Lower Limit: 3
7165 | Upper Limit: 6
7166 |
7167 | ##### Classes
7168 | Title: Hospitalized, not on O2, requiring ongoing care
7169 |
7170 | ##### Categories
7171 |
7172 | ##### Measurements
7173 | Group Id: OG000
7174 | Value: 3
7175 | Lower Limit: 2
7176 | Upper Limit: 5
7177 |
7178 | ##### Measurements
7179 | Group Id: OG001
7180 | Value: 3
7181 | Lower Limit: 2
7182 | Upper Limit: 5
7183 |
7184 | ##### Classes
7185 | Title: Hospitalized, not requiring O2, no longer req care
7186 |
7187 | ##### Categories
7188 |
7189 | ##### Measurements
7190 | Group Id: OG000
7191 | Value: 1
7192 | Lower Limit: 0
7193 | Upper Limit: 2
7194 |
7195 | ##### Measurements
7196 | Group Id: OG001
7197 | Value: 1
7198 | Lower Limit: 0
7199 | Upper Limit: 2
7200 |
7201 | ##### Classes
7202 | Title: Not hospitalized, limit on activities/req home O2
7203 |
7204 | ##### Categories
7205 |
7206 | ##### Measurements
7207 | Group Id: OG000
7208 | Value: 19
7209 | Lower Limit: 16
7210 | Upper Limit: 23
7211 |
7212 | ##### Measurements
7213 | Group Id: OG001
7214 | Value: 20
7215 | Lower Limit: 17
7216 | Upper Limit: 23
7217 |
7218 | ##### Classes
7219 | Title: Not hospitalized, no limitations on activities
7220 |
7221 | ##### Categories
7222 |
7223 | ##### Measurements
7224 | Group Id: OG000
7225 | Value: 36
7226 | Lower Limit: 32
7227 | Upper Limit: 41
7228 |
7229 | ##### Measurements
7230 | Group Id: OG001
7231 | Value: 46
7232 | Lower Limit: 42
7233 | Upper Limit: 50
7234 |
7235 | ##### Classes
7236 | Title: No clinical status score reported - Hospitalized
7237 |
7238 | ##### Categories
7239 |
7240 | ##### Measurements
7241 | Group Id: OG000
7242 | Value: 0.2
7243 | Lower Limit: 0
7244 | Upper Limit: 1
7245 |
7246 | ##### Measurements
7247 | Group Id: OG001
7248 | Value: 0
7249 | Lower Limit: 0
7250 | Upper Limit: 1
7251 |
7252 | ##### Classes
7253 | Title: No clinical status score reported - Discharged
7254 |
7255 | ##### Categories
7256 |
7257 | ##### Measurements
7258 | Group Id: OG000
7259 | Value: 3
7260 | Lower Limit: 2
7261 | Upper Limit: 5
7262 |
7263 | ##### Measurements
7264 | Group Id: OG001
7265 | Value: 1
7266 | Lower Limit: 1
7267 | Upper Limit: 3
7268 |
7269 | ##### Classes
7270 | Title: No clinical status score reported - Discontinued
7271 |
7272 | ##### Categories
7273 |
7274 | ##### Measurements
7275 | Group Id: OG000
7276 | Value: 5
7277 | Lower Limit: 3
7278 | Upper Limit: 7
7279 |
7280 | ##### Measurements
7281 | Group Id: OG001
7282 | Value: 7
7283 | Lower Limit: 5
7284 | Upper Limit: 9
7285 |
7286 | ##### Classes
7287 | Title: Completed study without reporting score
7288 |
7289 | ##### Categories
7290 |
7291 | ##### Measurements
7292 | Group Id: OG000
7293 | Value: 3
7294 | Lower Limit: 2
7295 | Upper Limit: 4
7296 |
7297 | ##### Measurements
7298 | Group Id: OG001
7299 | Value: 2
7300 | Lower Limit: 1
7301 | Upper Limit: 4
7302 |
7303 | #### Outcome Measures
7304 | Type: SECONDARY
7305 | Title:
7306 | Percentage of Participants Reporting Grade 3 and 4 Clinical and/or
7307 | Laboratory Adverse Events (AEs)
7308 | Description:
7309 | Grade 3 AEs are defined as events that interrupt usual activities of
7310 | daily living, or significantly affects clinical status, or may require
7311 | intensive therapeutic intervention. Severe events are usually
7312 | incapacitating. Grade 4 AEs are defined as events that are potentially
7313 | life threatening.
7314 | Population Description:
7315 | The safety population includes all participants with available data post
7316 | baseline, analyzed as treated.
7317 | Reporting Status: POSTED
7318 | Param Type: NUMBER
7319 | Dispersion Type: 95% Confidence Interval
7320 | Unit Of Measure: percentage of participants
7321 | Time Frame: Day 1 through Day 29
7322 |
7323 | ##### Groups
7324 | Id: OG000
7325 | Title: Placebo
7326 | Description:
7327 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
7328 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
7329 | while hospitalized for up to a 10 days total course.
7330 |
7331 | ##### Groups
7332 | Id: OG001
7333 | Title: Remdesivir
7334 | Description:
7335 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
7336 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
7337 | up to a 10 days total course.
7338 |
7339 | ##### Denoms
7340 | Units: Participants
7341 |
7342 | ##### Counts
7343 | Group Id: OG000
7344 | Value: 516
7345 |
7346 | ##### Counts
7347 | Group Id: OG001
7348 | Value: 532
7349 |
7350 | ##### Classes
7351 |
7352 | ##### Categories
7353 |
7354 | ##### Measurements
7355 | Group Id: OG000
7356 | Value: 57
7357 | Lower Limit: 52.8
7358 | Upper Limit: 61.5
7359 |
7360 | ##### Measurements
7361 | Group Id: OG001
7362 | Value: 51
7363 | Lower Limit: 47.0
7364 | Upper Limit: 55.6
7365 |
7366 | ##### Analyses
7367 | Non Inferiority Type: SUPERIORITY
7368 | P Value: 0.058
7369 | Statistical Method: Barnard's Exact Test
7370 | Group Ids: OG000, OG001
7371 |
7372 | #### Outcome Measures
7373 | Type: SECONDARY
7374 | Title: Percentage of Participants Reporting Serious Adverse Events (SAEs)
7375 | Description:
7376 | An SAE is defined as an AE or suspected adverse reaction is considered
7377 | serious if, in the view of either the investigator or the sponsor, it
7378 | results in death, a life-threatening AE, inpatient hospitalization or
7379 | prolongation of existing hospitalization, a persistent or significant
7380 | incapacity or substantial disruption of the ability to conduct normal
7381 | life functions, or a congenital anomaly/birth defect.
7382 | Population Description:
7383 | The safety population includes all participants with available data post
7384 | baseline, analyzed as treated.
7385 | Reporting Status: POSTED
7386 | Param Type: NUMBER
7387 | Dispersion Type: 95% Confidence Interval
7388 | Unit Of Measure: percentage of participants
7389 | Time Frame: Day 1 through Day 29
7390 |
7391 | ##### Groups
7392 | Id: OG000
7393 | Title: Placebo
7394 | Description:
7395 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
7396 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
7397 | while hospitalized for up to a 10 days total course.
7398 |
7399 | ##### Groups
7400 | Id: OG001
7401 | Title: Remdesivir
7402 | Description:
7403 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
7404 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
7405 | up to a 10 days total course.
7406 |
7407 | ##### Denoms
7408 | Units: Participants
7409 |
7410 | ##### Counts
7411 | Group Id: OG000
7412 | Value: 516
7413 |
7414 | ##### Counts
7415 | Group Id: OG001
7416 | Value: 532
7417 |
7418 | ##### Classes
7419 |
7420 | ##### Categories
7421 |
7422 | ##### Measurements
7423 | Group Id: OG000
7424 | Value: 32
7425 | Lower Limit: 27.7
7426 | Upper Limit: 35.7
7427 |
7428 | ##### Measurements
7429 | Group Id: OG001
7430 | Value: 24
7431 | Lower Limit: 20.9
7432 | Upper Limit: 28.3
7433 |
7434 | ##### Analyses
7435 | Non Inferiority Type: SUPERIORITY
7436 | P Value: 0.010
7437 | Statistical Method: Barnard's Exact Test
7438 | Group Ids: OG000, OG001
7439 |
7440 | #### Outcome Measures
7441 | Type: SECONDARY
7442 | Title:
7443 | Percentage of Participants Discontinued or Temporarily Suspended From
7444 | Investigational Therapeutics
7445 | Description:
7446 | Participants may have been discontinued from investigational
7447 | therapeutics due to discharge or death. The halting or slowing of the
7448 | infusion for any reason was collected, as was missed doses in the series
7449 | of 10 doses.
7450 | Population Description:
7451 | The intent-to-treat (ITT) population includes all participants who were
7452 | randomized
7453 | Reporting Status: POSTED
7454 | Param Type: NUMBER
7455 | Dispersion Type: 95% Confidence Interval
7456 | Unit Of Measure: percentage of participants
7457 | Time Frame: Day 1 through Day 10
7458 |
7459 | ##### Groups
7460 | Id: OG000
7461 | Title: Placebo
7462 | Description:
7463 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
7464 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
7465 | while hospitalized for up to a 10 days total course.
7466 |
7467 | ##### Groups
7468 | Id: OG001
7469 | Title: Remdesivir
7470 | Description:
7471 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
7472 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
7473 | up to a 10 days total course.
7474 |
7475 | ##### Denoms
7476 | Units: Participants
7477 |
7478 | ##### Counts
7479 | Group Id: OG000
7480 | Value: 521
7481 |
7482 | ##### Counts
7483 | Group Id: OG001
7484 | Value: 541
7485 |
7486 | ##### Classes
7487 | Title: Discontinued due to discharge
7488 |
7489 | ##### Categories
7490 |
7491 | ##### Measurements
7492 | Group Id: OG000
7493 | Value: 30
7494 | Lower Limit: 26
7495 | Upper Limit: 34
7496 |
7497 | ##### Measurements
7498 | Group Id: OG001
7499 | Value: 41
7500 | Lower Limit: 37
7501 | Upper Limit: 45
7502 |
7503 | ##### Classes
7504 | Title: Discontinued due to death
7505 |
7506 | ##### Categories
7507 |
7508 | ##### Measurements
7509 | Group Id: OG000
7510 | Value: 4
7511 | Lower Limit: 2
7512 | Upper Limit: 6
7513 |
7514 | ##### Measurements
7515 | Group Id: OG001
7516 | Value: 3
7517 | Lower Limit: 2
7518 | Upper Limit: 5
7519 |
7520 | ##### Classes
7521 | Title: Any infusions halted or slowed
7522 |
7523 | ##### Categories
7524 |
7525 | ##### Measurements
7526 | Group Id: OG000
7527 | Value: 2
7528 | Lower Limit: 1
7529 | Upper Limit: 4
7530 |
7531 | ##### Measurements
7532 | Group Id: OG001
7533 | Value: 2
7534 | Lower Limit: 1
7535 | Upper Limit: 4
7536 |
7537 | ##### Classes
7538 | Title: Missed any maintenance dose
7539 |
7540 | ##### Categories
7541 |
7542 | ##### Measurements
7543 | Group Id: OG000
7544 | Value: 21
7545 | Lower Limit: 18
7546 | Upper Limit: 25
7547 |
7548 | ##### Measurements
7549 | Group Id: OG001
7550 | Value: 16
7551 | Lower Limit: 13
7552 | Upper Limit: 19
7553 |
7554 | #### Outcome Measures
7555 | Type: SECONDARY
7556 | Title: Duration of Hospitalization
7557 | Description:
7558 | Duration of hospitalization was determined two ways. The first includes
7559 | imputations for participants who died. The second method is restricted
7560 | to participants who did not die.
7561 | Population Description:
7562 | The intent-to-treat (ITT) population includes all participants who were
7563 | randomized
7564 | Reporting Status: POSTED
7565 | Param Type: MEDIAN
7566 | Dispersion Type: Inter-Quartile Range
7567 | Unit Of Measure: Days
7568 | Time Frame: Day 1 through Day 29
7569 |
7570 | ##### Groups
7571 | Id: OG000
7572 | Title: Placebo
7573 | Description:
7574 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
7575 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
7576 | while hospitalized for up to a 10 days total course.
7577 |
7578 | ##### Groups
7579 | Id: OG001
7580 | Title: Remdesivir
7581 | Description:
7582 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
7583 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
7584 | up to a 10 days total course.
7585 |
7586 | ##### Denoms
7587 | Units: Participants
7588 |
7589 | ##### Counts
7590 | Group Id: OG000
7591 | Value: 521
7592 |
7593 | ##### Counts
7594 | Group Id: OG001
7595 | Value: 541
7596 |
7597 | ##### Classes
7598 | Title: Including imputation for participants who died
7599 |
7600 | ##### Denoms
7601 | Units: Participants
7602 |
7603 | ##### Counts
7604 | Group Id: OG000
7605 | Value: 521
7606 |
7607 | ##### Counts
7608 | Group Id: OG001
7609 | Value: 541
7610 |
7611 | ##### Categories
7612 |
7613 | ##### Measurements
7614 | Group Id: OG000
7615 | Value: 17
7616 | Lower Limit: 8
7617 | Upper Limit: 28
7618 |
7619 | ##### Measurements
7620 | Group Id: OG001
7621 | Value: 12
7622 | Lower Limit: 6
7623 | Upper Limit: 28
7624 |
7625 | ##### Classes
7626 | Title: Restricted to participants who did not die
7627 |
7628 | ##### Denoms
7629 | Units: Participants
7630 |
7631 | ##### Counts
7632 | Group Id: OG000
7633 | Value: 443
7634 |
7635 | ##### Counts
7636 | Group Id: OG001
7637 | Value: 480
7638 |
7639 | ##### Categories
7640 |
7641 | ##### Measurements
7642 | Group Id: OG000
7643 | Value: 14
7644 | Lower Limit: 7
7645 | Upper Limit: 27
7646 |
7647 | ##### Measurements
7648 | Group Id: OG001
7649 | Value: 10
7650 | Lower Limit: 5
7651 | Upper Limit: 21
7652 |
7653 | #### Outcome Measures
7654 | Type: SECONDARY
7655 | Title: Duration of New Non-invasive Ventilation or High Flow Oxygen Use
7656 | Description:
7657 | Duration of new non-invasive ventilation or high flow oxygen use was
7658 | measured in days among participants who were not on non-invasive
7659 | ventilation or high-flow oxygen use at baseline, determined two ways.
7660 | The first includes imputations for participants who died. The second
7661 | method is restricted to participants who did not die
7662 | Population Description:
7663 | The analysis population is restricted to randomized participants who
7664 | were not on non-invasive ventilation or high-flow oxygen at baseline but
7665 | who subsequently required non-invasive or high-flow oxygen.
7666 | Reporting Status: POSTED
7667 | Param Type: MEDIAN
7668 | Dispersion Type: Inter-Quartile Range
7669 | Unit Of Measure: Days
7670 | Time Frame: Day 1 through Day 29
7671 |
7672 | ##### Groups
7673 | Id: OG000
7674 | Title: Placebo
7675 | Description:
7676 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
7677 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
7678 | while hospitalized for up to a 10 days total course.
7679 |
7680 | ##### Groups
7681 | Id: OG001
7682 | Title: Remdesivir
7683 | Description:
7684 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
7685 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
7686 | up to a 10 days total course.
7687 |
7688 | ##### Denoms
7689 | Units: Participants
7690 |
7691 | ##### Counts
7692 | Group Id: OG000
7693 | Value: 64
7694 |
7695 | ##### Counts
7696 | Group Id: OG001
7697 | Value: 52
7698 |
7699 | ##### Classes
7700 | Title: Including imputations for participants who died
7701 |
7702 | ##### Denoms
7703 | Units: Participants
7704 |
7705 | ##### Counts
7706 | Group Id: OG000
7707 | Value: 64
7708 |
7709 | ##### Counts
7710 | Group Id: OG001
7711 | Value: 52
7712 |
7713 | ##### Categories
7714 |
7715 | ##### Measurements
7716 | Group Id: OG000
7717 | Value: 4
7718 | Lower Limit: 2
7719 | Upper Limit: 23.5
7720 |
7721 | ##### Measurements
7722 | Group Id: OG001
7723 | Value: 3
7724 | Lower Limit: 1
7725 | Upper Limit: 10.5
7726 |
7727 | ##### Classes
7728 | Title: Among participants who did not die
7729 |
7730 | ##### Denoms
7731 | Units: Participants
7732 |
7733 | ##### Counts
7734 | Group Id: OG000
7735 | Value: 50
7736 |
7737 | ##### Counts
7738 | Group Id: OG001
7739 | Value: 43
7740 |
7741 | ##### Categories
7742 |
7743 | ##### Measurements
7744 | Group Id: OG000
7745 | Value: 3
7746 | Lower Limit: 2
7747 | Upper Limit: 6
7748 |
7749 | ##### Measurements
7750 | Group Id: OG001
7751 | Value: 3
7752 | Lower Limit: 1
7753 | Upper Limit: 6
7754 |
7755 | #### Outcome Measures
7756 | Type: SECONDARY
7757 | Title: Duration of New Oxygen Use
7758 | Description:
7759 | Duration of new oxygen use was measured in days among participants who
7760 | were not on oxygen at baseline, determined two ways. The first includes
7761 | imputations for participants who died. The second method is restricted
7762 | to participants who did not die
7763 |
7764 | .
7765 | Population Description:
7766 | The analysis population is restricted to randomized participants who
7767 | were not on oxygen at baseline but who subsequently required oxygen.
7768 | Reporting Status: POSTED
7769 | Param Type: MEDIAN
7770 | Dispersion Type: Inter-Quartile Range
7771 | Unit Of Measure: Days
7772 | Time Frame: Day 1 through Day 29
7773 |
7774 | ##### Groups
7775 | Id: OG000
7776 | Title: Placebo
7777 | Description:
7778 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
7779 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
7780 | while hospitalized for up to a 10 days total course.
7781 |
7782 | ##### Groups
7783 | Id: OG001
7784 | Title: Remdesivir
7785 | Description:
7786 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
7787 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
7788 | up to a 10 days total course.
7789 |
7790 | ##### Denoms
7791 | Units: Participants
7792 |
7793 | ##### Counts
7794 | Group Id: OG000
7795 | Value: 28
7796 |
7797 | ##### Counts
7798 | Group Id: OG001
7799 | Value: 27
7800 |
7801 | ##### Classes
7802 | Title: Including imputations for participants who died
7803 |
7804 | ##### Denoms
7805 | Units: Participants
7806 |
7807 | ##### Counts
7808 | Group Id: OG000
7809 | Value: 28
7810 |
7811 | ##### Counts
7812 | Group Id: OG001
7813 | Value: 27
7814 |
7815 | ##### Categories
7816 |
7817 | ##### Measurements
7818 | Group Id: OG000
7819 | Value: 5.5
7820 | Lower Limit: 1
7821 | Upper Limit: 15
7822 |
7823 | ##### Measurements
7824 | Group Id: OG001
7825 | Value: 4
7826 | Lower Limit: 2
7827 | Upper Limit: 12
7828 |
7829 | ##### Classes
7830 | Title: Among participants who did not die
7831 |
7832 | ##### Denoms
7833 | Units: Participants
7834 |
7835 | ##### Counts
7836 | Group Id: OG000
7837 | Value: 25
7838 |
7839 | ##### Counts
7840 | Group Id: OG001
7841 | Value: 24
7842 |
7843 | ##### Categories
7844 |
7845 | ##### Measurements
7846 | Group Id: OG000
7847 | Value: 3
7848 | Lower Limit: 1
7849 | Upper Limit: 13
7850 |
7851 | ##### Measurements
7852 | Group Id: OG001
7853 | Value: 3.5
7854 | Lower Limit: 2
7855 | Upper Limit: 5.5
7856 |
7857 | #### Outcome Measures
7858 | Type: SECONDARY
7859 | Title:
7860 | Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO)
7861 | Use
7862 | Description:
7863 | Duration of new ventilator or ECMO use was measured in days among
7864 | participants who were not on a ventilator or ECMO at baseline,
7865 | determined two ways. The first includes imputations for participants who
7866 | died. The second method is restricted to participants who did not die
7867 | Population Description:
7868 | The analysis population is restricted to randomized participants not on
7869 | a ventilator or ECMO at baseline but who subsequently required a
7870 | ventilator or ECMO.
7871 | Reporting Status: POSTED
7872 | Param Type: MEDIAN
7873 | Dispersion Type: Inter-Quartile Range
7874 | Unit Of Measure: Days
7875 | Time Frame: Day 1 through Day 29
7876 |
7877 | ##### Groups
7878 | Id: OG000
7879 | Title: Placebo
7880 | Description:
7881 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
7882 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
7883 | while hospitalized for up to a 10 days total course.
7884 |
7885 | ##### Groups
7886 | Id: OG001
7887 | Title: Remdesivir
7888 | Description:
7889 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
7890 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
7891 | up to a 10 days total course.
7892 |
7893 | ##### Denoms
7894 | Units: Participants
7895 |
7896 | ##### Counts
7897 | Group Id: OG000
7898 | Value: 82
7899 |
7900 | ##### Counts
7901 | Group Id: OG001
7902 | Value: 52
7903 |
7904 | ##### Classes
7905 | Title: Including imputations for participants who died
7906 |
7907 | ##### Denoms
7908 | Units: Participants
7909 |
7910 | ##### Counts
7911 | Group Id: OG000
7912 | Value: 82
7913 |
7914 | ##### Counts
7915 | Group Id: OG001
7916 | Value: 52
7917 |
7918 | ##### Categories
7919 |
7920 | ##### Measurements
7921 | Group Id: OG000
7922 | Value: 23
7923 | Lower Limit: 12
7924 | Upper Limit: 28
7925 |
7926 | ##### Measurements
7927 | Group Id: OG001
7928 | Value: 21.5
7929 | Lower Limit: 9
7930 | Upper Limit: 28
7931 |
7932 | ##### Classes
7933 | Title: Among participants who did not die
7934 |
7935 | ##### Denoms
7936 | Units: Participants
7937 |
7938 | ##### Counts
7939 | Group Id: OG000
7940 | Value: 57
7941 |
7942 | ##### Counts
7943 | Group Id: OG001
7944 | Value: 39
7945 |
7946 | ##### Categories
7947 |
7948 | ##### Measurements
7949 | Group Id: OG000
7950 | Value: 16
7951 | Lower Limit: 9
7952 | Upper Limit: 24
7953 |
7954 | ##### Measurements
7955 | Group Id: OG001
7956 | Value: 14
7957 | Lower Limit: 5
7958 | Upper Limit: 26
7959 |
7960 | #### Outcome Measures
7961 | Type: SECONDARY
7962 | Title:
7963 | Percentage of Participants Requiring New Non-invasive Ventilation or
7964 | High-flow Oxygen Use
7965 | Description:
7966 | New non-invasive ventilation or high-flow oxygen use was determined as
7967 | the percentage of subject not on non-invasive ventilation or high-flow
7968 | oxygen at baseline.
7969 | Population Description:
7970 | The analysis population is restricted to randomized participants who
7971 | were not on non-invasive or high-flow oxygen at baseline.
7972 | Reporting Status: POSTED
7973 | Param Type: NUMBER
7974 | Dispersion Type: 95% Confidence Interval
7975 | Unit Of Measure: percentage of participants
7976 | Time Frame: Day 1 through Day 29
7977 |
7978 | ##### Groups
7979 | Id: OG000
7980 | Title: Placebo
7981 | Description:
7982 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
7983 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
7984 | while hospitalized for up to a 10 days total course.
7985 |
7986 | ##### Groups
7987 | Id: OG001
7988 | Title: Remdesivir
7989 | Description:
7990 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
7991 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
7992 | up to a 10 days total course.
7993 |
7994 | ##### Denoms
7995 | Units: Participants
7996 |
7997 | ##### Counts
7998 | Group Id: OG000
7999 | Value: 266
8000 |
8001 | ##### Counts
8002 | Group Id: OG001
8003 | Value: 307
8004 |
8005 | ##### Classes
8006 |
8007 | ##### Categories
8008 |
8009 | ##### Measurements
8010 | Group Id: OG000
8011 | Value: 24
8012 | Lower Limit: 19
8013 | Upper Limit: 30
8014 |
8015 | ##### Measurements
8016 | Group Id: OG001
8017 | Value: 17
8018 | Lower Limit: 13
8019 | Upper Limit: 22
8020 |
8021 | #### Outcome Measures
8022 | Type: SECONDARY
8023 | Title: Percentage of Participants Requiring New Oxygen Use
8024 | Description:
8025 | The percentage of participants requiring new oxygen use was determined
8026 | as the percentage of participants not requiring oxygen at baseline
8027 | Population Description:
8028 | The analysis population is restricted to randomized participants not
8029 | requiring oxygen at baseline.
8030 | Reporting Status: POSTED
8031 | Param Type: NUMBER
8032 | Dispersion Type: 95% Confidence Interval
8033 | Unit Of Measure: percentage of participants
8034 | Time Frame: Day 1 through Day 29
8035 |
8036 | ##### Groups
8037 | Id: OG000
8038 | Title: Placebo
8039 | Description:
8040 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
8041 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
8042 | while hospitalized for up to a 10 days total course.
8043 |
8044 | ##### Groups
8045 | Id: OG001
8046 | Title: Remdesivir
8047 | Description:
8048 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
8049 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
8050 | up to a 10 days total course.
8051 |
8052 | ##### Denoms
8053 | Units: Participants
8054 |
8055 | ##### Counts
8056 | Group Id: OG000
8057 | Value: 63
8058 |
8059 | ##### Counts
8060 | Group Id: OG001
8061 | Value: 75
8062 |
8063 | ##### Classes
8064 |
8065 | ##### Categories
8066 |
8067 | ##### Measurements
8068 | Group Id: OG000
8069 | Value: 44
8070 | Lower Limit: 33
8071 | Upper Limit: 57
8072 |
8073 | ##### Measurements
8074 | Group Id: OG001
8075 | Value: 36
8076 | Lower Limit: 26
8077 | Upper Limit: 47
8078 |
8079 | #### Outcome Measures
8080 | Type: SECONDARY
8081 | Title:
8082 | Percentage of Participants Requiring New Ventilator or Extracorporeal
8083 | Membrane Oxygenation (ECMO) Use
8084 | Description:
8085 | The percentage of participants requiring new ventilator or ECMO use was
8086 | determined as the percentage not on a ventilator or ECMO at baseline
8087 | Population Description:
8088 | The analysis population is restricted to randomized participants not on
8089 | a ventilator or ECMO at baseline.
8090 | Reporting Status: POSTED
8091 | Param Type: NUMBER
8092 | Dispersion Type: 95% Confidence Interval
8093 | Unit Of Measure: percentage of participants
8094 | Time Frame: Day 1 through Day 29
8095 |
8096 | ##### Groups
8097 | Id: OG000
8098 | Title: Placebo
8099 | Description:
8100 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
8101 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
8102 | while hospitalized for up to a 10 days total course.
8103 |
8104 | ##### Groups
8105 | Id: OG001
8106 | Title: Remdesivir
8107 | Description:
8108 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
8109 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
8110 | up to a 10 days total course.
8111 |
8112 | ##### Denoms
8113 | Units: Participants
8114 |
8115 | ##### Counts
8116 | Group Id: OG000
8117 | Value: 364
8118 |
8119 | ##### Counts
8120 | Group Id: OG001
8121 | Value: 402
8122 |
8123 | ##### Classes
8124 |
8125 | ##### Categories
8126 |
8127 | ##### Measurements
8128 | Group Id: OG000
8129 | Value: 23
8130 | Lower Limit: 19
8131 | Upper Limit: 27
8132 |
8133 | ##### Measurements
8134 | Group Id: OG001
8135 | Value: 13
8136 | Lower Limit: 10
8137 | Upper Limit: 17
8138 |
8139 | #### Outcome Measures
8140 | Type: SECONDARY
8141 | Title: Mean Change in the Ordinal Scale
8142 | Description:
8143 | The ordinal scale is an assessment of the clinical status at the first
8144 | assessment of a given study day. The scale is as follows: 8) Death; 7)
8145 | Hospitalized, on invasive mechanical ventilation or extracorporeal
8146 | membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
8147 | ventilation or high flow oxygen devices; 5) Hospitalized, requiring
8148 | supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
8149 | - requiring ongoing medical care (COVID-19 related or otherwise); 3)
8150 | Hospitalized, not requiring supplemental oxygen - no longer requires
8151 | ongoing medical care; 2) Not hospitalized, limitation on activities
8152 | and/or requiring home oxygen; 1) Not hospitalized, no limitations on
8153 | activities. A positive change indicates a worsening and a negative
8154 | change is an improvement.
8155 | Population Description:
8156 | The intent-to-treat (ITT) population includes all participants who were
8157 | randomized reporting a clinical score. Missing values were imputed using
8158 | Last Observation Carried Forward. Clinical scores of 8 were carried
8159 | forward from the date of death for participants who died.
8160 | Reporting Status: POSTED
8161 | Param Type: MEAN
8162 | Dispersion Type: Standard Deviation
8163 | Unit Of Measure: units on a scale
8164 | Time Frame: Day 1, 3, 5, 8, 11, 15, 22, and 29
8165 |
8166 | ##### Groups
8167 | Id: OG000
8168 | Title: Placebo
8169 | Description:
8170 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
8171 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
8172 | while hospitalized for up to a 10 days total course.
8173 |
8174 | ##### Groups
8175 | Id: OG001
8176 | Title: Remdesivir
8177 | Description:
8178 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
8179 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
8180 | up to a 10 days total course.
8181 |
8182 | ##### Denoms
8183 | Units: Participants
8184 |
8185 | ##### Counts
8186 | Group Id: OG000
8187 | Value: 518
8188 |
8189 | ##### Counts
8190 | Group Id: OG001
8191 | Value: 533
8192 |
8193 | ##### Classes
8194 | Title: Day 3
8195 |
8196 | ##### Categories
8197 |
8198 | ##### Measurements
8199 | Group Id: OG000
8200 | Value: 0.2
8201 | Spread: 0.6
8202 |
8203 | ##### Measurements
8204 | Group Id: OG001
8205 | Value: 0.1
8206 | Spread: 0.6
8207 |
8208 | ##### Classes
8209 | Title: Day 5
8210 |
8211 | ##### Categories
8212 |
8213 | ##### Measurements
8214 | Group Id: OG000
8215 | Value: 0.1
8216 | Spread: 0.9
8217 |
8218 | ##### Measurements
8219 | Group Id: OG001
8220 | Value: 0.0
8221 | Spread: 0.8
8222 |
8223 | ##### Classes
8224 | Title: Day 8
8225 |
8226 | ##### Categories
8227 |
8228 | ##### Measurements
8229 | Group Id: OG000
8230 | Value: 0.0
8231 | Spread: 0.1
8232 |
8233 | ##### Measurements
8234 | Group Id: OG001
8235 | Value: -0.2
8236 | Spread: 1.0
8237 |
8238 | ##### Classes
8239 | Title: Day 11
8240 |
8241 | ##### Categories
8242 |
8243 | ##### Measurements
8244 | Group Id: OG000
8245 | Value: -0.1
8246 | Spread: 1.3
8247 |
8248 | ##### Measurements
8249 | Group Id: OG001
8250 | Value: -0.3
8251 | Spread: 1.1
8252 |
8253 | ##### Classes
8254 | Title: Day 15
8255 |
8256 | ##### Categories
8257 |
8258 | ##### Measurements
8259 | Group Id: OG000
8260 | Value: -1.4
8261 | Spread: 2.3
8262 |
8263 | ##### Measurements
8264 | Group Id: OG001
8265 | Value: -1.9
8266 | Spread: 2.1
8267 |
8268 | ##### Classes
8269 | Title: Day 22
8270 |
8271 | ##### Categories
8272 |
8273 | ##### Measurements
8274 | Group Id: OG000
8275 | Value: -1.9
8276 | Spread: 2.5
8277 |
8278 | ##### Measurements
8279 | Group Id: OG001
8280 | Value: -2.4
8281 | Spread: 2.2
8282 |
8283 | ##### Classes
8284 | Title: Day 29
8285 |
8286 | ##### Categories
8287 |
8288 | ##### Measurements
8289 | Group Id: OG000
8290 | Value: -2.3
8291 | Spread: 2.6
8292 |
8293 | ##### Measurements
8294 | Group Id: OG001
8295 | Value: -2.7
8296 | Spread: 2.3
8297 |
8298 | #### Outcome Measures
8299 | Type: SECONDARY
8300 | Title: 14-day Participant Mortality
8301 | Description:
8302 | The mortality rate was determined as the proportion of participants who
8303 | died by study Day 15.
8304 | Population Description: The ITT population consists of all participants as randomized.
8305 | Reporting Status: POSTED
8306 | Param Type: NUMBER
8307 | Dispersion Type: 95% Confidence Interval
8308 | Unit Of Measure: Proportion of participants
8309 | Time Frame: Day 1 through Day 15
8310 |
8311 | ##### Groups
8312 | Id: OG000
8313 | Title: Placebo
8314 | Description:
8315 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
8316 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
8317 | while hospitalized for up to a 10 days total course.
8318 |
8319 | ##### Groups
8320 | Id: OG001
8321 | Title: Remdesivir
8322 | Description:
8323 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
8324 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
8325 | up to a 10 days total course.
8326 |
8327 | ##### Denoms
8328 | Units: Participants
8329 |
8330 | ##### Counts
8331 | Group Id: OG000
8332 | Value: 521
8333 |
8334 | ##### Counts
8335 | Group Id: OG001
8336 | Value: 541
8337 |
8338 | ##### Classes
8339 |
8340 | ##### Categories
8341 |
8342 | ##### Measurements
8343 | Group Id: OG000
8344 | Value: 0.12
8345 | Lower Limit: 0.09
8346 | Upper Limit: 0.15
8347 |
8348 | ##### Measurements
8349 | Group Id: OG001
8350 | Value: 0.07
8351 | Lower Limit: 0.05
8352 | Upper Limit: 0.09
8353 |
8354 | #### Outcome Measures
8355 | Type: SECONDARY
8356 | Title: 29-day Participant Mortality
8357 | Description:
8358 | The mortality rate was determined as the proportion of participants who
8359 | died by study Day 29.
8360 | Population Description: The ITT population includes all participants as randomized
8361 | Reporting Status: POSTED
8362 | Param Type: NUMBER
8363 | Dispersion Type: 95% Confidence Interval
8364 | Unit Of Measure: Proportion of participants
8365 | Time Frame: Day 1 through Day 29
8366 |
8367 | ##### Groups
8368 | Id: OG000
8369 | Title: Placebo
8370 | Description:
8371 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
8372 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
8373 | while hospitalized for up to a 10 days total course.
8374 |
8375 | ##### Groups
8376 | Id: OG001
8377 | Title: Remdesivir
8378 | Description:
8379 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
8380 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
8381 | up to a 10 days total course.
8382 |
8383 | ##### Denoms
8384 | Units: Participants
8385 |
8386 | ##### Counts
8387 | Group Id: OG000
8388 | Value: 521
8389 |
8390 | ##### Counts
8391 | Group Id: OG001
8392 | Value: 541
8393 |
8394 | ##### Classes
8395 |
8396 | ##### Categories
8397 |
8398 | ##### Measurements
8399 | Group Id: OG000
8400 | Value: 0.15
8401 | Lower Limit: 0.12
8402 | Upper Limit: 0.19
8403 |
8404 | ##### Measurements
8405 | Group Id: OG001
8406 | Value: 0.11
8407 | Lower Limit: 0.09
8408 | Upper Limit: 0.15
8409 |
8410 | #### Outcome Measures
8411 | Type: SECONDARY
8412 | Title: Time to an Improvement by at Least One Category Using an Ordinal Scale
8413 | Description:
8414 | The ordinal scale is an assessment of the clinical status at the first
8415 | assessment of a given study day. The scale is as follows: 8) Death; 7)
8416 | Hospitalized, on invasive mechanical ventilation or extracorporeal
8417 | membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
8418 | ventilation or high flow oxygen devices; 5) Hospitalized, requiring
8419 | supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
8420 | - requiring ongoing medical care (COVID-19 related or otherwise); 3)
8421 | Hospitalized, not requiring supplemental oxygen - no longer requires
8422 | ongoing medical care; 2) Not hospitalized, limitation on activities
8423 | and/or requiring home oxygen; 1) Not hospitalized, no limitations on
8424 | activities. Time to improvement by at least one category was determined
8425 | for each participant
8426 | Population Description: The ITT population includes all participants as randomized
8427 | Reporting Status: POSTED
8428 | Param Type: MEDIAN
8429 | Dispersion Type: 95% Confidence Interval
8430 | Unit Of Measure: Days
8431 | Time Frame: Day 1 through Day 29
8432 |
8433 | ##### Groups
8434 | Id: OG000
8435 | Title: Placebo
8436 | Description:
8437 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
8438 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
8439 | while hospitalized for up to a 10 days total course.
8440 |
8441 | ##### Groups
8442 | Id: OG001
8443 | Title: Remdesivir
8444 | Description:
8445 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
8446 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
8447 | up to a 10 days total course.
8448 |
8449 | ##### Denoms
8450 | Units: Participants
8451 |
8452 | ##### Counts
8453 | Group Id: OG000
8454 | Value: 521
8455 |
8456 | ##### Counts
8457 | Group Id: OG001
8458 | Value: 541
8459 |
8460 | ##### Classes
8461 |
8462 | ##### Categories
8463 |
8464 | ##### Measurements
8465 | Group Id: OG000
8466 | Value: 9
8467 | Lower Limit: 8
8468 | Upper Limit: 11
8469 |
8470 | ##### Measurements
8471 | Group Id: OG001
8472 | Value: 7
8473 | Lower Limit: 6
8474 | Upper Limit: 8
8475 |
8476 | ##### Analyses
8477 | Non Inferiority Type: SUPERIORITY
8478 | P Value: 0.002
8479 | Statistical Method: Log Rank
8480 | Param Type: Cox Proportional Hazard
8481 | Param Value: 1.23
8482 | Ci Pct Value: 95
8483 | Ci Num Sides: TWO_SIDED
8484 | Ci Lower Limit: 1.08
8485 | Ci Upper Limit: 1.41
8486 | Group Ids: OG000, OG001
8487 |
8488 | #### Outcome Measures
8489 | Type: SECONDARY
8490 | Title: Time to an Improvement of at Least Two Categories Using an Ordinal Scale
8491 | Description:
8492 | The ordinal scale is an assessment of the clinical status at the first
8493 | assessment of a given study day. The scale is as follows: 1) Death; 2)
8494 | Hospitalized, on invasive mechanical ventilation or extracorporeal
8495 | membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive
8496 | ventilation or high flow oxygen devices; 4) Hospitalized, requiring
8497 | supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen
8498 | - requiring ongoing medical care (COVID-19 related or otherwise); 6)
8499 | Hospitalized, not requiring supplemental oxygen - no longer requires
8500 | ongoing medical care; 7) Not hospitalized, limitation on activities
8501 | and/or requiring home oxygen; 8) Not hospitalized, no limitations on
8502 | activities. Time to improvement by at least two categories was
8503 | determined for each participant
8504 | Population Description: The ITT population includes all participants as randomized
8505 | Reporting Status: POSTED
8506 | Param Type: MEDIAN
8507 | Dispersion Type: 95% Confidence Interval
8508 | Unit Of Measure: Days
8509 | Time Frame: Day 1 through Day 29
8510 |
8511 | ##### Groups
8512 | Id: OG000
8513 | Title: Placebo
8514 | Description:
8515 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
8516 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
8517 | while hospitalized for up to a 10 days total course.
8518 |
8519 | ##### Groups
8520 | Id: OG001
8521 | Title: Remdesivir
8522 | Description:
8523 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
8524 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
8525 | up to a 10 days total course.
8526 |
8527 | ##### Denoms
8528 | Units: Participants
8529 |
8530 | ##### Counts
8531 | Group Id: OG000
8532 | Value: 521
8533 |
8534 | ##### Counts
8535 | Group Id: OG001
8536 | Value: 541
8537 |
8538 | ##### Classes
8539 |
8540 | ##### Categories
8541 |
8542 | ##### Measurements
8543 | Group Id: OG000
8544 | Value: 14
8545 | Lower Limit: 13
8546 | Upper Limit: 15
8547 |
8548 | ##### Measurements
8549 | Group Id: OG001
8550 | Value: 11
8551 | Lower Limit: 10
8552 | Upper Limit: 13
8553 |
8554 | ##### Analyses
8555 | Non Inferiority Type: SUPERIORITY
8556 | P Value: <0.001
8557 | Statistical Method: Log Rank
8558 | Param Type: Cox Proportional Hazard
8559 | Param Value: 1.29
8560 | Ci Pct Value: 95
8561 | Ci Num Sides: TWO_SIDED
8562 | Ci Lower Limit: 1.12
8563 | Ci Upper Limit: 1.48
8564 | Group Ids: OG000, OG001
8565 |
8566 | #### Outcome Measures
8567 | Type: SECONDARY
8568 | Title:
8569 | Time to Discharge or to a NEWS of 2 or Less and Maintained for 24 Hours,
8570 | Whichever Occurs First
8571 | Description:
8572 | The NEW score has demonstrated an ability to discriminate patients at
8573 | risk of poor outcomes. This score is based on 7 clinical parameters
8574 | (respiration rate, oxygen saturation, any supplemental oxygen,
8575 | temperature, systolic blood pressure, heart rate, level of
8576 | consciousness). The NEW Score is being used as an efficacy measure. The
8577 | minimum score is 0, representing the better outcome, and the maximum
8578 | value is 19, representing the worse outcome. The time to discharge or a
8579 | NEWS of less than or equal to 2 was determined for each participant.
8580 | Population Description: The ITT population includes all participants as randomized.
8581 | Reporting Status: POSTED
8582 | Param Type: MEDIAN
8583 | Dispersion Type: 95% Confidence Interval
8584 | Unit Of Measure: Days
8585 | Time Frame: Day 1 through Day 29
8586 |
8587 | ##### Groups
8588 | Id: OG000
8589 | Title: Placebo
8590 | Description:
8591 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
8592 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
8593 | while hospitalized for up to a 10 days total course.
8594 |
8595 | ##### Groups
8596 | Id: OG001
8597 | Title: Remdesivir
8598 | Description:
8599 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
8600 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
8601 | up to a 10 days total course.
8602 |
8603 | ##### Denoms
8604 | Units: Participants
8605 |
8606 | ##### Counts
8607 | Group Id: OG000
8608 | Value: 521
8609 |
8610 | ##### Counts
8611 | Group Id: OG001
8612 | Value: 541
8613 |
8614 | ##### Classes
8615 |
8616 | ##### Categories
8617 |
8618 | ##### Measurements
8619 | Group Id: OG000
8620 | Value: 12
8621 | Lower Limit: 10
8622 | Upper Limit: 15
8623 |
8624 | ##### Measurements
8625 | Group Id: OG001
8626 | Value: 8
8627 | Lower Limit: 7
8628 | Upper Limit: 9
8629 |
8630 | ##### Analyses
8631 | Non Inferiority Type: SUPERIORITY
8632 | P Value: <0.001
8633 | Statistical Method: Log Rank
8634 | Param Type: Cox Proportional Hazard
8635 | Param Value: 1.27
8636 | Ci Pct Value: 95
8637 | Ci Num Sides: TWO_SIDED
8638 | Ci Lower Limit: 1.10
8639 | Ci Upper Limit: 1.46
8640 | Group Ids: OG000, OG001
8641 |
8642 | #### Outcome Measures
8643 | Type: PRIMARY
8644 | Title: Time to Recovery by Race
8645 | Description:
8646 | Day of recovery is defined as the first day on which the subject
8647 | satisfies one of the following three categories from the ordinal scale:
8648 | 1) Hospitalized, not requiring supplemental oxygen - no longer requires
8649 | ongoing medical care; 2) Not hospitalized, limitation on activities
8650 | and/or requiring home oxygen; 3) Not hospitalized, no limitations on
8651 | activities.
8652 | Population Description:
8653 | The intent-to-treat (ITT) population includes all participants who were
8654 | randomized
8655 | Reporting Status: POSTED
8656 | Param Type: MEDIAN
8657 | Dispersion Type: 95% Confidence Interval
8658 | Unit Of Measure: Days
8659 | Time Frame: Day 1 through Day 29
8660 |
8661 | ##### Groups
8662 | Id: OG000
8663 | Title: Placebo
8664 | Description:
8665 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
8666 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
8667 | while hospitalized for up to a 10 days total course.
8668 |
8669 | ##### Groups
8670 | Id: OG001
8671 | Title: Remdesivir
8672 | Description:
8673 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
8674 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
8675 | up to a 10 days total course.
8676 |
8677 | ##### Denoms
8678 | Units: Participants
8679 |
8680 | ##### Counts
8681 | Group Id: OG000
8682 | Value: 521
8683 |
8684 | ##### Counts
8685 | Group Id: OG001
8686 | Value: 541
8687 |
8688 | ##### Classes
8689 | Title: Asian
8690 |
8691 | ##### Denoms
8692 | Units: Participants
8693 |
8694 | ##### Counts
8695 | Group Id: OG000
8696 | Value: 56
8697 |
8698 | ##### Counts
8699 | Group Id: OG001
8700 | Value: 79
8701 |
8702 | ##### Categories
8703 |
8704 | ##### Measurements
8705 | Group Id: OG000
8706 | Value: 12.0
8707 | Lower Limit: 9.0
8708 | Upper Limit: 15.0
8709 |
8710 | ##### Measurements
8711 | Group Id: OG001
8712 | Value: 11.0
8713 | Lower Limit: 9.0
8714 | Upper Limit: 15.0
8715 |
8716 | ##### Classes
8717 | Title: Black or African American
8718 |
8719 | ##### Denoms
8720 | Units: Participants
8721 |
8722 | ##### Counts
8723 | Group Id: OG000
8724 | Value: 117
8725 |
8726 | ##### Counts
8727 | Group Id: OG001
8728 | Value: 109
8729 |
8730 | ##### Categories
8731 |
8732 | ##### Measurements
8733 | Group Id: OG000
8734 | Value: 15.0
8735 | Lower Limit: 10.0
8736 | Upper Limit: 21.0
8737 |
8738 | ##### Measurements
8739 | Group Id: OG001
8740 | Value: 10.0
8741 | Lower Limit: 7.0
8742 | Upper Limit: 16.0
8743 |
8744 | ##### Classes
8745 | Title: White
8746 |
8747 | ##### Denoms
8748 | Units: Participants
8749 |
8750 | ##### Counts
8751 | Group Id: OG000
8752 | Value: 287
8753 |
8754 | ##### Counts
8755 | Group Id: OG001
8756 | Value: 279
8757 |
8758 | ##### Categories
8759 |
8760 | ##### Measurements
8761 | Group Id: OG000
8762 | Value: 15.0
8763 | Lower Limit: 12.0
8764 | Upper Limit: 19.0
8765 |
8766 | ##### Measurements
8767 | Group Id: OG001
8768 | Value: 9.0
8769 | Lower Limit: 8.0
8770 | Upper Limit: 12.0
8771 |
8772 | ##### Classes
8773 | Title: Other
8774 |
8775 | ##### Denoms
8776 | Units: Participants
8777 |
8778 | ##### Counts
8779 | Group Id: OG000
8780 | Value: 61
8781 |
8782 | ##### Counts
8783 | Group Id: OG001
8784 | Value: 74
8785 |
8786 | ##### Categories
8787 |
8788 | ##### Measurements
8789 | Group Id: OG000
8790 | Value: 24.0
8791 | Lower Limit: 15.0
8792 | Upper Limit: NA
8793 | Comment:
8794 | A large number of participants at the median estimate resulted in little
8795 | variability at the 50th percentile and the methodology described by
8796 | Klein and Moeschberger (1997) was unable to compute an upper confidence
8797 | limit.
8798 |
8799 | ##### Measurements
8800 | Group Id: OG001
8801 | Value: 9.0
8802 | Lower Limit: 6.0
8803 | Upper Limit: 14.0
8804 |
8805 | ##### Analyses
8806 | Group Description: This analysis is for Asian participants
8807 | Non Inferiority Type: SUPERIORITY
8808 | Param Type: Cox Proportional Hazard
8809 | Param Value: 1.07
8810 | Ci Pct Value: 95
8811 | Ci Num Sides: TWO_SIDED
8812 | Ci Lower Limit: 0.73
8813 | Ci Upper Limit: 1.58
8814 | Group Ids: OG000, OG001
8815 |
8816 | ##### Analyses
8817 | Group Description: This analysis is for Black or African American participants
8818 | Non Inferiority Type: SUPERIORITY
8819 | Param Type: Cox Proportional Hazard
8820 | Param Value: 1.25
8821 | Ci Pct Value: 95
8822 | Ci Num Sides: TWO_SIDED
8823 | Ci Lower Limit: 0.91
8824 | Ci Upper Limit: 1.72
8825 | Group Ids: OG000, OG001
8826 |
8827 | ##### Analyses
8828 | Group Description: This analysis is for White participants
8829 | Non Inferiority Type: SUPERIORITY
8830 | Param Type: Cox Proportional Hazard
8831 | Param Value: 1.29
8832 | Ci Pct Value: 95
8833 | Ci Num Sides: TWO_SIDED
8834 | Ci Lower Limit: 1.06
8835 | Ci Upper Limit: 1.57
8836 | Group Ids: OG000, OG001
8837 |
8838 | ##### Analyses
8839 | Group Description: This analysis is for Race of Other participants
8840 | Non Inferiority Type: SUPERIORITY
8841 | Param Type: Cox Proportional Hazard
8842 | Param Value: 1.68
8843 | Ci Pct Value: 95
8844 | Ci Num Sides: TWO_SIDED
8845 | Ci Lower Limit: 1.10
8846 | Ci Upper Limit: 2.58
8847 | Group Ids: OG000, OG001
8848 |
8849 | #### Outcome Measures
8850 | Type: PRIMARY
8851 | Title: Time to Recovery by Ethnicity
8852 | Description:
8853 | Day of recovery is defined as the first day on which the subject
8854 | satisfies one of the following three categories from the ordinal scale:
8855 | 1) Hospitalized, not requiring supplemental oxygen - no longer requires
8856 | ongoing medical care; 2) Not hospitalized, limitation on activities
8857 | and/or requiring home oxygen; 3) Not hospitalized, no limitations on
8858 | activities.
8859 | Population Description:
8860 | The intent-to-treat (ITT) population includes all participants who were
8861 | randomized and for whom Ethnicity was reported
8862 | Reporting Status: POSTED
8863 | Param Type: MEDIAN
8864 | Dispersion Type: 95% Confidence Interval
8865 | Unit Of Measure: Days
8866 | Time Frame: Day 1 through Day 29
8867 |
8868 | ##### Groups
8869 | Id: OG000
8870 | Title: Placebo
8871 | Description:
8872 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
8873 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
8874 | while hospitalized for up to a 10 days total course.
8875 |
8876 | ##### Groups
8877 | Id: OG001
8878 | Title: Remdesivir
8879 | Description:
8880 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
8881 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
8882 | up to a 10 days total course.
8883 |
8884 | ##### Denoms
8885 | Units: Participants
8886 |
8887 | ##### Counts
8888 | Group Id: OG000
8889 | Value: 489
8890 |
8891 | ##### Counts
8892 | Group Id: OG001
8893 | Value: 516
8894 |
8895 | ##### Classes
8896 | Title: Not Hispanic or Latino
8897 |
8898 | ##### Denoms
8899 | Units: Participants
8900 |
8901 | ##### Counts
8902 | Group Id: OG000
8903 | Value: 373
8904 |
8905 | ##### Counts
8906 | Group Id: OG001
8907 | Value: 382
8908 |
8909 | ##### Categories
8910 |
8911 | ##### Measurements
8912 | Group Id: OG000
8913 | Value: 15.0
8914 | Lower Limit: 13.0
8915 | Upper Limit: 18.0
8916 |
8917 | ##### Measurements
8918 | Group Id: OG001
8919 | Value: 10.0
8920 | Lower Limit: 8.0
8921 | Upper Limit: 12.0
8922 |
8923 | ##### Classes
8924 | Title: Hispanic or Latino
8925 |
8926 | ##### Denoms
8927 | Units: Participants
8928 |
8929 | ##### Counts
8930 | Group Id: OG000
8931 | Value: 116
8932 |
8933 | ##### Counts
8934 | Group Id: OG001
8935 | Value: 134
8936 |
8937 | ##### Categories
8938 |
8939 | ##### Measurements
8940 | Group Id: OG000
8941 | Value: 12.5
8942 | Lower Limit: 9.0
8943 | Upper Limit: 22.0
8944 |
8945 | ##### Measurements
8946 | Group Id: OG001
8947 | Value: 10.0
8948 | Lower Limit: 7.0
8949 | Upper Limit: 14.0
8950 |
8951 | ##### Analyses
8952 | Group Description: This analysis is for Not Hispanic or Latino participants
8953 | Non Inferiority Type: SUPERIORITY
8954 | Param Type: Cox Proportional Hazard
8955 | Param Value: 1.31
8956 | Ci Pct Value: 95
8957 | Ci Num Sides: TWO_SIDED
8958 | Ci Lower Limit: 1.10
8959 | Ci Upper Limit: 1.55
8960 | Group Ids: OG000, OG001
8961 |
8962 | ##### Analyses
8963 | Group Description: This analysis is for Hispanic or Latino participants
8964 | Non Inferiority Type: SUPERIORITY
8965 | Param Type: Cox Proportional Hazard
8966 | Param Value: 1.28
8967 | Ci Pct Value: 95
8968 | Ci Num Sides: TWO_SIDED
8969 | Ci Lower Limit: 0.94
8970 | Ci Upper Limit: 1.73
8971 | Group Ids: OG000, OG001
8972 |
8973 | #### Outcome Measures
8974 | Type: PRIMARY
8975 | Title: Time to Recovery by Sex
8976 | Description:
8977 | Day of recovery is defined as the first day on which the subject
8978 | satisfies one of the following three categories from the ordinal scale:
8979 | 1) Hospitalized, not requiring supplemental oxygen - no longer requires
8980 | ongoing medical care; 2) Not hospitalized, limitation on activities
8981 | and/or requiring home oxygen; 3) Not hospitalized, no limitations on
8982 | activities.
8983 | Population Description:
8984 | The intent-to-treat (ITT) population includes all participants who were
8985 | randomized
8986 | Reporting Status: POSTED
8987 | Param Type: MEDIAN
8988 | Dispersion Type: 95% Confidence Interval
8989 | Unit Of Measure: Days
8990 | Time Frame: Day 1 through Day 29
8991 |
8992 | ##### Groups
8993 | Id: OG000
8994 | Title: Placebo
8995 | Description:
8996 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
8997 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
8998 | while hospitalized for up to a 10 days total course.
8999 |
9000 | ##### Groups
9001 | Id: OG001
9002 | Title: Remdesivir
9003 | Description:
9004 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
9005 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
9006 | up to a 10 days total course.
9007 |
9008 | ##### Denoms
9009 | Units: Participants
9010 |
9011 | ##### Counts
9012 | Group Id: OG000
9013 | Value: 521
9014 |
9015 | ##### Counts
9016 | Group Id: OG001
9017 | Value: 541
9018 |
9019 | ##### Classes
9020 | Title: Male
9021 |
9022 | ##### Denoms
9023 | Units: Participants
9024 |
9025 | ##### Counts
9026 | Group Id: OG000
9027 | Value: 332
9028 |
9029 | ##### Counts
9030 | Group Id: OG001
9031 | Value: 352
9032 |
9033 | ##### Categories
9034 |
9035 | ##### Measurements
9036 | Group Id: OG000
9037 | Value: 15.0
9038 | Lower Limit: 12.0
9039 | Upper Limit: 19.0
9040 |
9041 | ##### Measurements
9042 | Group Id: OG001
9043 | Value: 9.0
9044 | Lower Limit: 8.0
9045 | Upper Limit: 12.0
9046 |
9047 | ##### Classes
9048 | Title: Female
9049 |
9050 | ##### Denoms
9051 | Units: Participants
9052 |
9053 | ##### Counts
9054 | Group Id: OG000
9055 | Value: 189
9056 |
9057 | ##### Counts
9058 | Group Id: OG001
9059 | Value: 189
9060 |
9061 | ##### Categories
9062 |
9063 | ##### Measurements
9064 | Group Id: OG000
9065 | Value: 15.0
9066 | Lower Limit: 12.0
9067 | Upper Limit: 19.0
9068 |
9069 | ##### Measurements
9070 | Group Id: OG001
9071 | Value: 10.0
9072 | Lower Limit: 8.0
9073 | Upper Limit: 13.0
9074 |
9075 | ##### Analyses
9076 | Group Description: This analysis is for Male participants
9077 | Non Inferiority Type: SUPERIORITY
9078 | Param Type: Cox Proportional Hazard
9079 | Param Value: 1.30
9080 | Ci Pct Value: 95
9081 | Ci Num Sides: TWO_SIDED
9082 | Ci Lower Limit: 1.09
9083 | Ci Upper Limit: 1.56
9084 | Group Ids: OG000, OG001
9085 |
9086 | ##### Analyses
9087 | Group Description: This analysis is for Female participants
9088 | Non Inferiority Type: SUPERIORITY
9089 | Param Type: Cox Proportional Hazard
9090 | Param Value: 1.31
9091 | Ci Pct Value: 95
9092 | Ci Num Sides: TWO_SIDED
9093 | Ci Lower Limit: 1.03
9094 | Ci Upper Limit: 1.66
9095 | Group Ids: OG000, OG001
9096 |
9097 | ### Adverse Events Module
9098 | Frequency Threshold: 5
9099 | Time Frame:
9100 | Grade 3 and 4 serious and non-serious adverse events were collected for
9101 | 29 days after the first dose. Laboratory values were systematically
9102 | assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient,
9103 | and at Days 15 and 29.
9104 | Description:
9105 | Given the nature of severity of the underlying illness, participants
9106 | were expected to have many symptoms and abnormalities in vital signs and
9107 | laboratory values. All Grade 3 and 4 AEs were captured as AEs in this
9108 | trial. In addition, any Grade 2 or higher, suspected drug-related
9109 | hypersensitivity reaction was to be reported as an AE in this trial. All
9110 | cause mortality was calculated for the ITT population, while SAEs and
9111 | AEs reflect the as treated population.
9112 |
9113 | #### Event Groups
9114 | Id: EG000
9115 | Title: Placebo
9116 | Description:
9117 | 200 mg of Remdesivir placebo administered intravenously on Day 1,
9118 | followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
9119 | while hospitalized for up to a 10 days total course.
9120 | Deaths Num Affected: 77
9121 | Deaths Num At Risk: 521
9122 | Serious Num Affected: 163
9123 | Serious Num At Risk: 516
9124 | Other Num Affected: 295
9125 | Other Num At Risk: 516
9126 |
9127 | #### Event Groups
9128 | Id: EG001
9129 | Title: Remdesivir
9130 | Description:
9131 | 200 mg of Remdesivir administered intravenously on Day 1, followed by a
9132 | 100 mg once-daily maintenance dose of Remdesivir while hospitalized for
9133 | up to a 10 days total course.
9134 | Deaths Num Affected: 59
9135 | Deaths Num At Risk: 541
9136 | Serious Num Affected: 131
9137 | Serious Num At Risk: 532
9138 | Other Num Affected: 276
9139 | Other Num At Risk: 532
9140 |
9141 | #### Serious Events
9142 | Term: Coagulopathy
9143 | Organ System: Blood and lymphatic system disorders
9144 | Source Vocabulary: MedDRA (23.0)
9145 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9146 |
9147 | ##### Stats
9148 | Group Id: EG000
9149 | Num Events: 0
9150 | Num Affected: 0
9151 | Num At Risk: 516
9152 |
9153 | ##### Stats
9154 | Group Id: EG001
9155 | Num Events: 1
9156 | Num Affected: 1
9157 | Num At Risk: 532
9158 |
9159 | #### Serious Events
9160 | Term: Febrile neutropenia
9161 | Organ System: Blood and lymphatic system disorders
9162 | Source Vocabulary: MedDRA (23.0)
9163 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9164 |
9165 | ##### Stats
9166 | Group Id: EG000
9167 | Num Events: 0
9168 | Num Affected: 0
9169 | Num At Risk: 516
9170 |
9171 | ##### Stats
9172 | Group Id: EG001
9173 | Num Events: 1
9174 | Num Affected: 1
9175 | Num At Risk: 532
9176 |
9177 | #### Serious Events
9178 | Term: Anaemia
9179 | Organ System: Blood and lymphatic system disorders
9180 | Source Vocabulary: MedDRA (23.0)
9181 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9182 |
9183 | ##### Stats
9184 | Group Id: EG000
9185 | Num Events: 1
9186 | Num Affected: 1
9187 | Num At Risk: 516
9188 |
9189 | ##### Stats
9190 | Group Id: EG001
9191 | Num Events: 0
9192 | Num Affected: 0
9193 | Num At Risk: 532
9194 |
9195 | #### Serious Events
9196 | Term: Cardiac arrest
9197 | Organ System: Cardiac disorders
9198 | Source Vocabulary: MedDRA (23.0)
9199 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9200 |
9201 | ##### Stats
9202 | Group Id: EG000
9203 | Num Events: 7
9204 | Num Affected: 7
9205 | Num At Risk: 516
9206 |
9207 | ##### Stats
9208 | Group Id: EG001
9209 | Num Events: 10
9210 | Num Affected: 10
9211 | Num At Risk: 532
9212 |
9213 | #### Serious Events
9214 | Term: Atrial fibrillation
9215 | Organ System: Cardiac disorders
9216 | Source Vocabulary: MedDRA (23.0)
9217 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9218 |
9219 | ##### Stats
9220 | Group Id: EG000
9221 | Num Events: 2
9222 | Num Affected: 1
9223 | Num At Risk: 516
9224 |
9225 | ##### Stats
9226 | Group Id: EG001
9227 | Num Events: 6
9228 | Num Affected: 5
9229 | Num At Risk: 532
9230 |
9231 | #### Serious Events
9232 | Term: Cardio-respiratory arrest
9233 | Organ System: Cardiac disorders
9234 | Source Vocabulary: MedDRA (23.0)
9235 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9236 |
9237 | ##### Stats
9238 | Group Id: EG000
9239 | Num Events: 3
9240 | Num Affected: 3
9241 | Num At Risk: 516
9242 |
9243 | ##### Stats
9244 | Group Id: EG001
9245 | Num Events: 1
9246 | Num Affected: 1
9247 | Num At Risk: 532
9248 |
9249 | #### Serious Events
9250 | Term: Myocardial infarction
9251 | Organ System: Cardiac disorders
9252 | Source Vocabulary: MedDRA (23.0)
9253 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9254 |
9255 | ##### Stats
9256 | Group Id: EG000
9257 | Num Events: 4
9258 | Num Affected: 4
9259 | Num At Risk: 516
9260 |
9261 | ##### Stats
9262 | Group Id: EG001
9263 | Num Events: 0
9264 | Num Affected: 0
9265 | Num At Risk: 532
9266 |
9267 | #### Serious Events
9268 | Term: Supraventricular tachycardia
9269 | Organ System: Cardiac disorders
9270 | Source Vocabulary: MedDRA (23.0)
9271 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9272 |
9273 | ##### Stats
9274 | Group Id: EG000
9275 | Num Events: 3
9276 | Num Affected: 3
9277 | Num At Risk: 516
9278 |
9279 | ##### Stats
9280 | Group Id: EG001
9281 | Num Events: 0
9282 | Num Affected: 0
9283 | Num At Risk: 532
9284 |
9285 | #### Serious Events
9286 | Term: Ventricular tachycardia
9287 | Organ System: Cardiac disorders
9288 | Source Vocabulary: MedDRA (23.0)
9289 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9290 |
9291 | ##### Stats
9292 | Group Id: EG000
9293 | Num Events: 0
9294 | Num Affected: 0
9295 | Num At Risk: 516
9296 |
9297 | ##### Stats
9298 | Group Id: EG001
9299 | Num Events: 2
9300 | Num Affected: 2
9301 | Num At Risk: 532
9302 |
9303 | #### Serious Events
9304 | Term: Acute myocardial infarction
9305 | Organ System: Cardiac disorders
9306 | Source Vocabulary: MedDRA (23.0)
9307 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9308 |
9309 | ##### Stats
9310 | Group Id: EG000
9311 | Num Events: 1
9312 | Num Affected: 1
9313 | Num At Risk: 516
9314 |
9315 | ##### Stats
9316 | Group Id: EG001
9317 | Num Events: 1
9318 | Num Affected: 1
9319 | Num At Risk: 532
9320 |
9321 | #### Serious Events
9322 | Term: Cardiac failure
9323 | Organ System: Cardiac disorders
9324 | Source Vocabulary: MedDRA (23.0)
9325 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9326 |
9327 | ##### Stats
9328 | Group Id: EG000
9329 | Num Events: 1
9330 | Num Affected: 1
9331 | Num At Risk: 516
9332 |
9333 | ##### Stats
9334 | Group Id: EG001
9335 | Num Events: 1
9336 | Num Affected: 1
9337 | Num At Risk: 532
9338 |
9339 | #### Serious Events
9340 | Term: Cardiogenic shock
9341 | Organ System: Cardiac disorders
9342 | Source Vocabulary: MedDRA (23.0)
9343 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9344 |
9345 | ##### Stats
9346 | Group Id: EG000
9347 | Num Events: 2
9348 | Num Affected: 2
9349 | Num At Risk: 516
9350 |
9351 | ##### Stats
9352 | Group Id: EG001
9353 | Num Events: 0
9354 | Num Affected: 0
9355 | Num At Risk: 532
9356 |
9357 | #### Serious Events
9358 | Term: Acute coronary syndrome
9359 | Organ System: Cardiac disorders
9360 | Source Vocabulary: MedDRA (23.0)
9361 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9362 |
9363 | ##### Stats
9364 | Group Id: EG000
9365 | Num Events: 0
9366 | Num Affected: 0
9367 | Num At Risk: 516
9368 |
9369 | ##### Stats
9370 | Group Id: EG001
9371 | Num Events: 1
9372 | Num Affected: 1
9373 | Num At Risk: 532
9374 |
9375 | #### Serious Events
9376 | Term: Arrhythmia
9377 | Organ System: Cardiac disorders
9378 | Source Vocabulary: MedDRA (23.0)
9379 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9380 |
9381 | ##### Stats
9382 | Group Id: EG000
9383 | Num Events: 0
9384 | Num Affected: 0
9385 | Num At Risk: 516
9386 |
9387 | ##### Stats
9388 | Group Id: EG001
9389 | Num Events: 1
9390 | Num Affected: 1
9391 | Num At Risk: 532
9392 |
9393 | #### Serious Events
9394 | Term: Palpitations
9395 | Organ System: Cardiac disorders
9396 | Source Vocabulary: MedDRA (23.0)
9397 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9398 |
9399 | ##### Stats
9400 | Group Id: EG000
9401 | Num Events: 0
9402 | Num Affected: 0
9403 | Num At Risk: 516
9404 |
9405 | ##### Stats
9406 | Group Id: EG001
9407 | Num Events: 1
9408 | Num Affected: 1
9409 | Num At Risk: 532
9410 |
9411 | #### Serious Events
9412 | Term: Pulseless electrical activity
9413 | Organ System: Cardiac disorders
9414 | Source Vocabulary: MedDRA (23.0)
9415 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9416 |
9417 | ##### Stats
9418 | Group Id: EG000
9419 | Num Events: 0
9420 | Num Affected: 0
9421 | Num At Risk: 516
9422 |
9423 | ##### Stats
9424 | Group Id: EG001
9425 | Num Events: 1
9426 | Num Affected: 1
9427 | Num At Risk: 532
9428 |
9429 | #### Serious Events
9430 | Term: Ventricular fibrillation
9431 | Organ System: Cardiac disorders
9432 | Source Vocabulary: MedDRA (23.0)
9433 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9434 |
9435 | ##### Stats
9436 | Group Id: EG000
9437 | Num Events: 0
9438 | Num Affected: 0
9439 | Num At Risk: 516
9440 |
9441 | ##### Stats
9442 | Group Id: EG001
9443 | Num Events: 1
9444 | Num Affected: 1
9445 | Num At Risk: 532
9446 |
9447 | #### Serious Events
9448 | Term: Cardiac tamponade
9449 | Organ System: Cardiac disorders
9450 | Source Vocabulary: MedDRA (23.0)
9451 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9452 |
9453 | ##### Stats
9454 | Group Id: EG000
9455 | Num Events: 1
9456 | Num Affected: 1
9457 | Num At Risk: 516
9458 |
9459 | ##### Stats
9460 | Group Id: EG001
9461 | Num Events: 0
9462 | Num Affected: 0
9463 | Num At Risk: 532
9464 |
9465 | #### Serious Events
9466 | Term: Intestinal ischaemia
9467 | Organ System: Gastrointestinal disorders
9468 | Source Vocabulary: MedDRA (23.0)
9469 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9470 |
9471 | ##### Stats
9472 | Group Id: EG000
9473 | Num Events: 0
9474 | Num Affected: 0
9475 | Num At Risk: 516
9476 |
9477 | ##### Stats
9478 | Group Id: EG001
9479 | Num Events: 3
9480 | Num Affected: 3
9481 | Num At Risk: 532
9482 |
9483 | #### Serious Events
9484 | Term: Diarrhoea
9485 | Organ System: Gastrointestinal disorders
9486 | Source Vocabulary: MedDRA (23.0)
9487 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9488 |
9489 | ##### Stats
9490 | Group Id: EG000
9491 | Num Events: 0
9492 | Num Affected: 0
9493 | Num At Risk: 516
9494 |
9495 | ##### Stats
9496 | Group Id: EG001
9497 | Num Events: 1
9498 | Num Affected: 1
9499 | Num At Risk: 532
9500 |
9501 | #### Serious Events
9502 | Term: Duodenal perforation
9503 | Organ System: Gastrointestinal disorders
9504 | Source Vocabulary: MedDRA (23.0)
9505 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9506 |
9507 | ##### Stats
9508 | Group Id: EG000
9509 | Num Events: 0
9510 | Num Affected: 0
9511 | Num At Risk: 516
9512 |
9513 | ##### Stats
9514 | Group Id: EG001
9515 | Num Events: 1
9516 | Num Affected: 1
9517 | Num At Risk: 532
9518 |
9519 | #### Serious Events
9520 | Term: Gastrointestinal haemorrhage
9521 | Organ System: Gastrointestinal disorders
9522 | Source Vocabulary: MedDRA (23.0)
9523 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9524 |
9525 | ##### Stats
9526 | Group Id: EG000
9527 | Num Events: 0
9528 | Num Affected: 0
9529 | Num At Risk: 516
9530 |
9531 | ##### Stats
9532 | Group Id: EG001
9533 | Num Events: 1
9534 | Num Affected: 1
9535 | Num At Risk: 532
9536 |
9537 | #### Serious Events
9538 | Term: Small intestinal perforation
9539 | Organ System: Gastrointestinal disorders
9540 | Source Vocabulary: MedDRA (23.0)
9541 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9542 |
9543 | ##### Stats
9544 | Group Id: EG000
9545 | Num Events: 0
9546 | Num Affected: 0
9547 | Num At Risk: 516
9548 |
9549 | ##### Stats
9550 | Group Id: EG001
9551 | Num Events: 1
9552 | Num Affected: 1
9553 | Num At Risk: 532
9554 |
9555 | #### Serious Events
9556 | Term: Haematemesis
9557 | Organ System: Gastrointestinal disorders
9558 | Source Vocabulary: MedDRA (23.0)
9559 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9560 |
9561 | ##### Stats
9562 | Group Id: EG000
9563 | Num Events: 1
9564 | Num Affected: 1
9565 | Num At Risk: 516
9566 |
9567 | ##### Stats
9568 | Group Id: EG001
9569 | Num Events: 0
9570 | Num Affected: 0
9571 | Num At Risk: 532
9572 |
9573 | #### Serious Events
9574 | Term: Peptic ulcer haemorrhage
9575 | Organ System: Gastrointestinal disorders
9576 | Source Vocabulary: MedDRA (23.0)
9577 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9578 |
9579 | ##### Stats
9580 | Group Id: EG000
9581 | Num Events: 1
9582 | Num Affected: 1
9583 | Num At Risk: 516
9584 |
9585 | ##### Stats
9586 | Group Id: EG001
9587 | Num Events: 0
9588 | Num Affected: 0
9589 | Num At Risk: 532
9590 |
9591 | #### Serious Events
9592 | Term: Small intestinal obstruction
9593 | Organ System: Gastrointestinal disorders
9594 | Source Vocabulary: MedDRA (23.0)
9595 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9596 |
9597 | ##### Stats
9598 | Group Id: EG000
9599 | Num Events: 1
9600 | Num Affected: 1
9601 | Num At Risk: 516
9602 |
9603 | ##### Stats
9604 | Group Id: EG001
9605 | Num Events: 0
9606 | Num Affected: 0
9607 | Num At Risk: 532
9608 |
9609 | #### Serious Events
9610 | Term: Multiple organ dysfunction syndrome
9611 | Organ System: General disorders
9612 | Source Vocabulary: MedDRA (23.0)
9613 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9614 |
9615 | ##### Stats
9616 | Group Id: EG000
9617 | Num Events: 3
9618 | Num Affected: 3
9619 | Num At Risk: 516
9620 |
9621 | ##### Stats
9622 | Group Id: EG001
9623 | Num Events: 5
9624 | Num Affected: 5
9625 | Num At Risk: 532
9626 |
9627 | #### Serious Events
9628 | Term: Pyrexia
9629 | Organ System: General disorders
9630 | Source Vocabulary: MedDRA (23.0)
9631 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9632 |
9633 | ##### Stats
9634 | Group Id: EG000
9635 | Num Events: 2
9636 | Num Affected: 2
9637 | Num At Risk: 516
9638 |
9639 | ##### Stats
9640 | Group Id: EG001
9641 | Num Events: 1
9642 | Num Affected: 1
9643 | Num At Risk: 532
9644 |
9645 | #### Serious Events
9646 | Term: Chest pain
9647 | Organ System: General disorders
9648 | Source Vocabulary: MedDRA (23.0)
9649 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9650 |
9651 | ##### Stats
9652 | Group Id: EG000
9653 | Num Events: 0
9654 | Num Affected: 0
9655 | Num At Risk: 516
9656 |
9657 | ##### Stats
9658 | Group Id: EG001
9659 | Num Events: 1
9660 | Num Affected: 1
9661 | Num At Risk: 532
9662 |
9663 | #### Serious Events
9664 | Term: Death
9665 | Organ System: General disorders
9666 | Source Vocabulary: MedDRA (23.0)
9667 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9668 |
9669 | ##### Stats
9670 | Group Id: EG000
9671 | Num Events: 1
9672 | Num Affected: 1
9673 | Num At Risk: 516
9674 |
9675 | ##### Stats
9676 | Group Id: EG001
9677 | Num Events: 0
9678 | Num Affected: 0
9679 | Num At Risk: 532
9680 |
9681 | #### Serious Events
9682 | Term: Hepatitis
9683 | Organ System: Hepatobiliary disorders
9684 | Source Vocabulary: MedDRA (23.0)
9685 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9686 |
9687 | ##### Stats
9688 | Group Id: EG000
9689 | Num Events: 1
9690 | Num Affected: 1
9691 | Num At Risk: 516
9692 |
9693 | ##### Stats
9694 | Group Id: EG001
9695 | Num Events: 0
9696 | Num Affected: 0
9697 | Num At Risk: 532
9698 |
9699 | #### Serious Events
9700 | Term: Ischaemic hepatitis
9701 | Organ System: Hepatobiliary disorders
9702 | Source Vocabulary: MedDRA (23.0)
9703 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9704 |
9705 | ##### Stats
9706 | Group Id: EG000
9707 | Num Events: 1
9708 | Num Affected: 1
9709 | Num At Risk: 516
9710 |
9711 | ##### Stats
9712 | Group Id: EG001
9713 | Num Events: 0
9714 | Num Affected: 0
9715 | Num At Risk: 532
9716 |
9717 | #### Serious Events
9718 | Term: Drug hypersensitivity
9719 | Organ System: Immune system disorders
9720 | Source Vocabulary: MedDRA (23.0)
9721 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9722 |
9723 | ##### Stats
9724 | Group Id: EG000
9725 | Num Events: 1
9726 | Num Affected: 1
9727 | Num At Risk: 516
9728 |
9729 | ##### Stats
9730 | Group Id: EG001
9731 | Num Events: 0
9732 | Num Affected: 0
9733 | Num At Risk: 532
9734 |
9735 | #### Serious Events
9736 | Term: Septic shock
9737 | Organ System: Infections and infestations
9738 | Source Vocabulary: MedDRA (23.0)
9739 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9740 |
9741 | ##### Stats
9742 | Group Id: EG000
9743 | Num Events: 15
9744 | Num Affected: 15
9745 | Num At Risk: 516
9746 |
9747 | ##### Stats
9748 | Group Id: EG001
9749 | Num Events: 8
9750 | Num Affected: 8
9751 | Num At Risk: 532
9752 |
9753 | #### Serious Events
9754 | Term: COVID-19
9755 | Organ System: Infections and infestations
9756 | Source Vocabulary: MedDRA (23.0)
9757 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9758 |
9759 | ##### Stats
9760 | Group Id: EG000
9761 | Num Events: 5
9762 | Num Affected: 5
9763 | Num At Risk: 516
9764 |
9765 | ##### Stats
9766 | Group Id: EG001
9767 | Num Events: 2
9768 | Num Affected: 2
9769 | Num At Risk: 532
9770 |
9771 | #### Serious Events
9772 | Term: Bacteraemia
9773 | Organ System: Infections and infestations
9774 | Source Vocabulary: MedDRA (23.0)
9775 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9776 |
9777 | ##### Stats
9778 | Group Id: EG000
9779 | Num Events: 2
9780 | Num Affected: 2
9781 | Num At Risk: 516
9782 |
9783 | ##### Stats
9784 | Group Id: EG001
9785 | Num Events: 1
9786 | Num Affected: 1
9787 | Num At Risk: 532
9788 |
9789 | #### Serious Events
9790 | Term: COVID-19 pneumonia
9791 | Organ System: Infections and infestations
9792 | Source Vocabulary: MedDRA (23.0)
9793 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9794 |
9795 | ##### Stats
9796 | Group Id: EG000
9797 | Num Events: 2
9798 | Num Affected: 2
9799 | Num At Risk: 516
9800 |
9801 | ##### Stats
9802 | Group Id: EG001
9803 | Num Events: 1
9804 | Num Affected: 1
9805 | Num At Risk: 532
9806 |
9807 | #### Serious Events
9808 | Term: Sepsis
9809 | Organ System: Infections and infestations
9810 | Source Vocabulary: MedDRA (23.0)
9811 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9812 |
9813 | ##### Stats
9814 | Group Id: EG000
9815 | Num Events: 2
9816 | Num Affected: 2
9817 | Num At Risk: 516
9818 |
9819 | ##### Stats
9820 | Group Id: EG001
9821 | Num Events: 1
9822 | Num Affected: 1
9823 | Num At Risk: 532
9824 |
9825 | #### Serious Events
9826 | Term: Pneumonia
9827 | Organ System: Infections and infestations
9828 | Source Vocabulary: MedDRA (23.0)
9829 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9830 |
9831 | ##### Stats
9832 | Group Id: EG000
9833 | Num Events: 2
9834 | Num Affected: 2
9835 | Num At Risk: 516
9836 |
9837 | ##### Stats
9838 | Group Id: EG001
9839 | Num Events: 0
9840 | Num Affected: 0
9841 | Num At Risk: 532
9842 |
9843 | #### Serious Events
9844 | Term: Catheter bacteraemia
9845 | Organ System: Infections and infestations
9846 | Source Vocabulary: MedDRA (23.0)
9847 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9848 |
9849 | ##### Stats
9850 | Group Id: EG000
9851 | Num Events: 0
9852 | Num Affected: 0
9853 | Num At Risk: 516
9854 |
9855 | ##### Stats
9856 | Group Id: EG001
9857 | Num Events: 1
9858 | Num Affected: 1
9859 | Num At Risk: 532
9860 |
9861 | #### Serious Events
9862 | Term: Gangrene
9863 | Organ System: Infections and infestations
9864 | Source Vocabulary: MedDRA (23.0)
9865 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9866 |
9867 | ##### Stats
9868 | Group Id: EG000
9869 | Num Events: 0
9870 | Num Affected: 0
9871 | Num At Risk: 516
9872 |
9873 | ##### Stats
9874 | Group Id: EG001
9875 | Num Events: 1
9876 | Num Affected: 1
9877 | Num At Risk: 532
9878 |
9879 | #### Serious Events
9880 | Term: Infectious pleural effusion
9881 | Organ System: Infections and infestations
9882 | Source Vocabulary: MedDRA (23.0)
9883 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9884 |
9885 | ##### Stats
9886 | Group Id: EG000
9887 | Num Events: 0
9888 | Num Affected: 0
9889 | Num At Risk: 516
9890 |
9891 | ##### Stats
9892 | Group Id: EG001
9893 | Num Events: 1
9894 | Num Affected: 1
9895 | Num At Risk: 532
9896 |
9897 | #### Serious Events
9898 | Term: Staphylococcal bacteraemia
9899 | Organ System: Infections and infestations
9900 | Source Vocabulary: MedDRA (23.0)
9901 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9902 |
9903 | ##### Stats
9904 | Group Id: EG000
9905 | Num Events: 0
9906 | Num Affected: 0
9907 | Num At Risk: 516
9908 |
9909 | ##### Stats
9910 | Group Id: EG001
9911 | Num Events: 1
9912 | Num Affected: 1
9913 | Num At Risk: 532
9914 |
9915 | #### Serious Events
9916 | Term: Urinary tract infection
9917 | Organ System: Infections and infestations
9918 | Source Vocabulary: MedDRA (23.0)
9919 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9920 |
9921 | ##### Stats
9922 | Group Id: EG000
9923 | Num Events: 0
9924 | Num Affected: 0
9925 | Num At Risk: 516
9926 |
9927 | ##### Stats
9928 | Group Id: EG001
9929 | Num Events: 1
9930 | Num Affected: 1
9931 | Num At Risk: 532
9932 |
9933 | #### Serious Events
9934 | Term: Bacterial sepsis
9935 | Organ System: Infections and infestations
9936 | Source Vocabulary: MedDRA (23.0)
9937 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9938 |
9939 | ##### Stats
9940 | Group Id: EG000
9941 | Num Events: 1
9942 | Num Affected: 1
9943 | Num At Risk: 516
9944 |
9945 | ##### Stats
9946 | Group Id: EG001
9947 | Num Events: 0
9948 | Num Affected: 0
9949 | Num At Risk: 532
9950 |
9951 | #### Serious Events
9952 | Term: Endocarditis bacterial
9953 | Organ System: Infections and infestations
9954 | Source Vocabulary: MedDRA (23.0)
9955 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9956 |
9957 | ##### Stats
9958 | Group Id: EG000
9959 | Num Events: 1
9960 | Num Affected: 1
9961 | Num At Risk: 516
9962 |
9963 | ##### Stats
9964 | Group Id: EG001
9965 | Num Events: 0
9966 | Num Affected: 0
9967 | Num At Risk: 532
9968 |
9969 | #### Serious Events
9970 | Term: Hip fracture
9971 | Organ System: Injury, poisoning and procedural complications
9972 | Source Vocabulary: MedDRA (23.0)
9973 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9974 |
9975 | ##### Stats
9976 | Group Id: EG000
9977 | Num Events: 0
9978 | Num Affected: 0
9979 | Num At Risk: 516
9980 |
9981 | ##### Stats
9982 | Group Id: EG001
9983 | Num Events: 1
9984 | Num Affected: 1
9985 | Num At Risk: 532
9986 |
9987 | #### Serious Events
9988 | Term: Infusion related reaction
9989 | Organ System: Injury, poisoning and procedural complications
9990 | Source Vocabulary: MedDRA (23.0)
9991 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
9992 |
9993 | ##### Stats
9994 | Group Id: EG000
9995 | Num Events: 0
9996 | Num Affected: 0
9997 | Num At Risk: 516
9998 |
9999 | ##### Stats
10000 | Group Id: EG001
10001 | Num Events: 1
10002 | Num Affected: 1
10003 | Num At Risk: 532
10004 |
10005 | #### Serious Events
10006 | Term: Procedural pneumothorax
10007 | Organ System: Injury, poisoning and procedural complications
10008 | Source Vocabulary: MedDRA (23.0)
10009 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10010 |
10011 | ##### Stats
10012 | Group Id: EG000
10013 | Num Events: 1
10014 | Num Affected: 1
10015 | Num At Risk: 516
10016 |
10017 | ##### Stats
10018 | Group Id: EG001
10019 | Num Events: 0
10020 | Num Affected: 0
10021 | Num At Risk: 532
10022 |
10023 | #### Serious Events
10024 | Term: Glomerular filtration rate decreased
10025 | Organ System: Investigations
10026 | Source Vocabulary: MedDRA (23.0)
10027 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10028 |
10029 | ##### Stats
10030 | Group Id: EG000
10031 | Num Events: 3
10032 | Num Affected: 2
10033 | Num At Risk: 516
10034 |
10035 | ##### Stats
10036 | Group Id: EG001
10037 | Num Events: 5
10038 | Num Affected: 5
10039 | Num At Risk: 532
10040 |
10041 | #### Serious Events
10042 | Term: Haemoglobin decreased
10043 | Organ System: Investigations
10044 | Source Vocabulary: MedDRA (23.0)
10045 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10046 |
10047 | ##### Stats
10048 | Group Id: EG000
10049 | Num Events: 2
10050 | Num Affected: 2
10051 | Num At Risk: 516
10052 |
10053 | ##### Stats
10054 | Group Id: EG001
10055 | Num Events: 1
10056 | Num Affected: 1
10057 | Num At Risk: 532
10058 |
10059 | #### Serious Events
10060 | Term: Oxygen saturation decreased
10061 | Organ System: Investigations
10062 | Source Vocabulary: MedDRA (23.0)
10063 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10064 |
10065 | ##### Stats
10066 | Group Id: EG000
10067 | Num Events: 1
10068 | Num Affected: 1
10069 | Num At Risk: 516
10070 |
10071 | ##### Stats
10072 | Group Id: EG001
10073 | Num Events: 1
10074 | Num Affected: 1
10075 | Num At Risk: 532
10076 |
10077 | #### Serious Events
10078 | Term: Blood creatinine increased
10079 | Organ System: Investigations
10080 | Source Vocabulary: MedDRA (23.0)
10081 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10082 |
10083 | ##### Stats
10084 | Group Id: EG000
10085 | Num Events: 0
10086 | Num Affected: 0
10087 | Num At Risk: 516
10088 |
10089 | ##### Stats
10090 | Group Id: EG001
10091 | Num Events: 1
10092 | Num Affected: 1
10093 | Num At Risk: 532
10094 |
10095 | #### Serious Events
10096 | Term: Lymphocyte count decreased
10097 | Organ System: Investigations
10098 | Source Vocabulary: MedDRA (23.0)
10099 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10100 |
10101 | ##### Stats
10102 | Group Id: EG000
10103 | Num Events: 0
10104 | Num Affected: 0
10105 | Num At Risk: 516
10106 |
10107 | ##### Stats
10108 | Group Id: EG001
10109 | Num Events: 1
10110 | Num Affected: 1
10111 | Num At Risk: 532
10112 |
10113 | #### Serious Events
10114 | Term: Acidosis
10115 | Organ System: Metabolism and nutrition disorders
10116 | Source Vocabulary: MedDRA (23.0)
10117 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10118 |
10119 | ##### Stats
10120 | Group Id: EG000
10121 | Num Events: 1
10122 | Num Affected: 1
10123 | Num At Risk: 516
10124 |
10125 | ##### Stats
10126 | Group Id: EG001
10127 | Num Events: 1
10128 | Num Affected: 1
10129 | Num At Risk: 532
10130 |
10131 | #### Serious Events
10132 | Term: Dehydration
10133 | Organ System: Metabolism and nutrition disorders
10134 | Source Vocabulary: MedDRA (23.0)
10135 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10136 |
10137 | ##### Stats
10138 | Group Id: EG000
10139 | Num Events: 0
10140 | Num Affected: 0
10141 | Num At Risk: 516
10142 |
10143 | ##### Stats
10144 | Group Id: EG001
10145 | Num Events: 1
10146 | Num Affected: 1
10147 | Num At Risk: 532
10148 |
10149 | #### Serious Events
10150 | Term: Hypernatraemia
10151 | Organ System: Metabolism and nutrition disorders
10152 | Source Vocabulary: MedDRA (23.0)
10153 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10154 |
10155 | ##### Stats
10156 | Group Id: EG000
10157 | Num Events: 0
10158 | Num Affected: 0
10159 | Num At Risk: 516
10160 |
10161 | ##### Stats
10162 | Group Id: EG001
10163 | Num Events: 1
10164 | Num Affected: 1
10165 | Num At Risk: 532
10166 |
10167 | #### Serious Events
10168 | Term: Hyponatraemia
10169 | Organ System: Metabolism and nutrition disorders
10170 | Source Vocabulary: MedDRA (23.0)
10171 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10172 |
10173 | ##### Stats
10174 | Group Id: EG000
10175 | Num Events: 0
10176 | Num Affected: 0
10177 | Num At Risk: 516
10178 |
10179 | ##### Stats
10180 | Group Id: EG001
10181 | Num Events: 1
10182 | Num Affected: 1
10183 | Num At Risk: 532
10184 |
10185 | #### Serious Events
10186 | Term: Decreased appetite
10187 | Organ System: Metabolism and nutrition disorders
10188 | Source Vocabulary: MedDRA (23.0)
10189 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10190 |
10191 | ##### Stats
10192 | Group Id: EG000
10193 | Num Events: 1
10194 | Num Affected: 1
10195 | Num At Risk: 516
10196 |
10197 | ##### Stats
10198 | Group Id: EG001
10199 | Num Events: 0
10200 | Num Affected: 0
10201 | Num At Risk: 532
10202 |
10203 | #### Serious Events
10204 | Term: Pain in extremity
10205 | Organ System: Musculoskeletal and connective tissue disorders
10206 | Source Vocabulary: MedDRA (23.0)
10207 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10208 |
10209 | ##### Stats
10210 | Group Id: EG000
10211 | Num Events: 0
10212 | Num Affected: 0
10213 | Num At Risk: 516
10214 |
10215 | ##### Stats
10216 | Group Id: EG001
10217 | Num Events: 1
10218 | Num Affected: 1
10219 | Num At Risk: 532
10220 |
10221 | #### Serious Events
10222 | Term: Myalgia
10223 | Organ System: Musculoskeletal and connective tissue disorders
10224 | Source Vocabulary: MedDRA (23.0)
10225 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10226 |
10227 | ##### Stats
10228 | Group Id: EG000
10229 | Num Events: 1
10230 | Num Affected: 1
10231 | Num At Risk: 516
10232 |
10233 | ##### Stats
10234 | Group Id: EG001
10235 | Num Events: 0
10236 | Num Affected: 0
10237 | Num At Risk: 532
10238 |
10239 | #### Serious Events
10240 | Term: Myopathy
10241 | Organ System: Musculoskeletal and connective tissue disorders
10242 | Source Vocabulary: MedDRA (23.0)
10243 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10244 |
10245 | ##### Stats
10246 | Group Id: EG000
10247 | Num Events: 1
10248 | Num Affected: 1
10249 | Num At Risk: 516
10250 |
10251 | ##### Stats
10252 | Group Id: EG001
10253 | Num Events: 0
10254 | Num Affected: 0
10255 | Num At Risk: 532
10256 |
10257 | #### Serious Events
10258 | Term: Cerebrovascular accident
10259 | Organ System: Nervous system disorders
10260 | Source Vocabulary: MedDRA (23.0)
10261 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10262 |
10263 | ##### Stats
10264 | Group Id: EG000
10265 | Num Events: 1
10266 | Num Affected: 1
10267 | Num At Risk: 516
10268 |
10269 | ##### Stats
10270 | Group Id: EG001
10271 | Num Events: 3
10272 | Num Affected: 3
10273 | Num At Risk: 532
10274 |
10275 | #### Serious Events
10276 | Term: Seizure
10277 | Organ System: Nervous system disorders
10278 | Source Vocabulary: MedDRA (23.0)
10279 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10280 |
10281 | ##### Stats
10282 | Group Id: EG000
10283 | Num Events: 1
10284 | Num Affected: 1
10285 | Num At Risk: 516
10286 |
10287 | ##### Stats
10288 | Group Id: EG001
10289 | Num Events: 2
10290 | Num Affected: 2
10291 | Num At Risk: 532
10292 |
10293 | #### Serious Events
10294 | Term: Cerebellar infarction
10295 | Organ System: Nervous system disorders
10296 | Source Vocabulary: MedDRA (23.0)
10297 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10298 |
10299 | ##### Stats
10300 | Group Id: EG000
10301 | Num Events: 0
10302 | Num Affected: 0
10303 | Num At Risk: 516
10304 |
10305 | ##### Stats
10306 | Group Id: EG001
10307 | Num Events: 1
10308 | Num Affected: 1
10309 | Num At Risk: 532
10310 |
10311 | #### Serious Events
10312 | Term: Cerebral haemorrhage
10313 | Organ System: Nervous system disorders
10314 | Source Vocabulary: MedDRA (23.0)
10315 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10316 |
10317 | ##### Stats
10318 | Group Id: EG000
10319 | Num Events: 0
10320 | Num Affected: 0
10321 | Num At Risk: 516
10322 |
10323 | ##### Stats
10324 | Group Id: EG001
10325 | Num Events: 1
10326 | Num Affected: 1
10327 | Num At Risk: 532
10328 |
10329 | #### Serious Events
10330 | Term: Encephalopathy
10331 | Organ System: Nervous system disorders
10332 | Source Vocabulary: MedDRA (23.0)
10333 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10334 |
10335 | ##### Stats
10336 | Group Id: EG000
10337 | Num Events: 0
10338 | Num Affected: 0
10339 | Num At Risk: 516
10340 |
10341 | ##### Stats
10342 | Group Id: EG001
10343 | Num Events: 1
10344 | Num Affected: 1
10345 | Num At Risk: 532
10346 |
10347 | #### Serious Events
10348 | Term: Subarachnoid haemorrhage
10349 | Organ System: Nervous system disorders
10350 | Source Vocabulary: MedDRA (23.0)
10351 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10352 |
10353 | ##### Stats
10354 | Group Id: EG000
10355 | Num Events: 0
10356 | Num Affected: 0
10357 | Num At Risk: 516
10358 |
10359 | ##### Stats
10360 | Group Id: EG001
10361 | Num Events: 1
10362 | Num Affected: 1
10363 | Num At Risk: 532
10364 |
10365 | #### Serious Events
10366 | Term: Depressed level of consciousness
10367 | Organ System: Nervous system disorders
10368 | Source Vocabulary: MedDRA (23.0)
10369 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10370 |
10371 | ##### Stats
10372 | Group Id: EG000
10373 | Num Events: 1
10374 | Num Affected: 1
10375 | Num At Risk: 516
10376 |
10377 | ##### Stats
10378 | Group Id: EG001
10379 | Num Events: 0
10380 | Num Affected: 0
10381 | Num At Risk: 532
10382 |
10383 | #### Serious Events
10384 | Term: Haemorrhagic transformation stroke
10385 | Organ System: Nervous system disorders
10386 | Source Vocabulary: MedDRA (23.0)
10387 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10388 |
10389 | ##### Stats
10390 | Group Id: EG000
10391 | Num Events: 1
10392 | Num Affected: 1
10393 | Num At Risk: 516
10394 |
10395 | ##### Stats
10396 | Group Id: EG001
10397 | Num Events: 0
10398 | Num Affected: 0
10399 | Num At Risk: 532
10400 |
10401 | #### Serious Events
10402 | Term: Hemiparesis
10403 | Organ System: Nervous system disorders
10404 | Source Vocabulary: MedDRA (23.0)
10405 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10406 |
10407 | ##### Stats
10408 | Group Id: EG000
10409 | Num Events: 1
10410 | Num Affected: 1
10411 | Num At Risk: 516
10412 |
10413 | ##### Stats
10414 | Group Id: EG001
10415 | Num Events: 0
10416 | Num Affected: 0
10417 | Num At Risk: 532
10418 |
10419 | #### Serious Events
10420 | Term: Intensive care unit acquired weakness
10421 | Organ System: Nervous system disorders
10422 | Source Vocabulary: MedDRA (23.0)
10423 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10424 |
10425 | ##### Stats
10426 | Group Id: EG000
10427 | Num Events: 1
10428 | Num Affected: 1
10429 | Num At Risk: 516
10430 |
10431 | ##### Stats
10432 | Group Id: EG001
10433 | Num Events: 0
10434 | Num Affected: 0
10435 | Num At Risk: 532
10436 |
10437 | #### Serious Events
10438 | Term: Ischaemic stroke
10439 | Organ System: Nervous system disorders
10440 | Source Vocabulary: MedDRA (23.0)
10441 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10442 |
10443 | ##### Stats
10444 | Group Id: EG000
10445 | Num Events: 1
10446 | Num Affected: 1
10447 | Num At Risk: 516
10448 |
10449 | ##### Stats
10450 | Group Id: EG001
10451 | Num Events: 0
10452 | Num Affected: 0
10453 | Num At Risk: 532
10454 |
10455 | #### Serious Events
10456 | Term: Mental status changes
10457 | Organ System: Psychiatric disorders
10458 | Source Vocabulary: MedDRA (23.0)
10459 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10460 |
10461 | ##### Stats
10462 | Group Id: EG000
10463 | Num Events: 0
10464 | Num Affected: 0
10465 | Num At Risk: 516
10466 |
10467 | ##### Stats
10468 | Group Id: EG001
10469 | Num Events: 1
10470 | Num Affected: 1
10471 | Num At Risk: 532
10472 |
10473 | #### Serious Events
10474 | Term: Psychotic disorder
10475 | Organ System: Psychiatric disorders
10476 | Source Vocabulary: MedDRA (23.0)
10477 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10478 |
10479 | ##### Stats
10480 | Group Id: EG000
10481 | Num Events: 1
10482 | Num Affected: 1
10483 | Num At Risk: 516
10484 |
10485 | ##### Stats
10486 | Group Id: EG001
10487 | Num Events: 0
10488 | Num Affected: 0
10489 | Num At Risk: 532
10490 |
10491 | #### Serious Events
10492 | Term: Acute kidney injury
10493 | Organ System: Renal and urinary disorders
10494 | Source Vocabulary: MedDRA (23.0)
10495 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10496 |
10497 | ##### Stats
10498 | Group Id: EG000
10499 | Num Events: 12
10500 | Num Affected: 12
10501 | Num At Risk: 516
10502 |
10503 | ##### Stats
10504 | Group Id: EG001
10505 | Num Events: 7
10506 | Num Affected: 7
10507 | Num At Risk: 532
10508 |
10509 | #### Serious Events
10510 | Term: Renal failure
10511 | Organ System: Renal and urinary disorders
10512 | Source Vocabulary: MedDRA (23.0)
10513 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10514 |
10515 | ##### Stats
10516 | Group Id: EG000
10517 | Num Events: 5
10518 | Num Affected: 5
10519 | Num At Risk: 516
10520 |
10521 | ##### Stats
10522 | Group Id: EG001
10523 | Num Events: 2
10524 | Num Affected: 2
10525 | Num At Risk: 532
10526 |
10527 | #### Serious Events
10528 | Term: Renal impairment
10529 | Organ System: Renal and urinary disorders
10530 | Source Vocabulary: MedDRA (23.0)
10531 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10532 |
10533 | ##### Stats
10534 | Group Id: EG000
10535 | Num Events: 3
10536 | Num Affected: 3
10537 | Num At Risk: 516
10538 |
10539 | ##### Stats
10540 | Group Id: EG001
10541 | Num Events: 1
10542 | Num Affected: 1
10543 | Num At Risk: 532
10544 |
10545 | #### Serious Events
10546 | Term: Respiratory failure
10547 | Organ System: Respiratory, thoracic and mediastinal disorders
10548 | Source Vocabulary: MedDRA (23.0)
10549 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10550 |
10551 | ##### Stats
10552 | Group Id: EG000
10553 | Num Events: 59
10554 | Num Affected: 58
10555 | Num At Risk: 516
10556 |
10557 | ##### Stats
10558 | Group Id: EG001
10559 | Num Events: 36
10560 | Num Affected: 35
10561 | Num At Risk: 532
10562 |
10563 | #### Serious Events
10564 | Term: Acute respiratory failure
10565 | Organ System: Respiratory, thoracic and mediastinal disorders
10566 | Source Vocabulary: MedDRA (23.0)
10567 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10568 |
10569 | ##### Stats
10570 | Group Id: EG000
10571 | Num Events: 14
10572 | Num Affected: 14
10573 | Num At Risk: 516
10574 |
10575 | ##### Stats
10576 | Group Id: EG001
10577 | Num Events: 8
10578 | Num Affected: 8
10579 | Num At Risk: 532
10580 |
10581 | #### Serious Events
10582 | Term: Respiratory distress
10583 | Organ System: Respiratory, thoracic and mediastinal disorders
10584 | Source Vocabulary: MedDRA (23.0)
10585 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10586 |
10587 | ##### Stats
10588 | Group Id: EG000
10589 | Num Events: 11
10590 | Num Affected: 11
10591 | Num At Risk: 516
10592 |
10593 | ##### Stats
10594 | Group Id: EG001
10595 | Num Events: 6
10596 | Num Affected: 6
10597 | Num At Risk: 532
10598 |
10599 | #### Serious Events
10600 | Term: Acute respiratory distress syndrome
10601 | Organ System: Respiratory, thoracic and mediastinal disorders
10602 | Source Vocabulary: MedDRA (23.0)
10603 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10604 |
10605 | ##### Stats
10606 | Group Id: EG000
10607 | Num Events: 5
10608 | Num Affected: 5
10609 | Num At Risk: 516
10610 |
10611 | ##### Stats
10612 | Group Id: EG001
10613 | Num Events: 7
10614 | Num Affected: 7
10615 | Num At Risk: 532
10616 |
10617 | #### Serious Events
10618 | Term: Pneumothorax
10619 | Organ System: Respiratory, thoracic and mediastinal disorders
10620 | Source Vocabulary: MedDRA (23.0)
10621 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10622 |
10623 | ##### Stats
10624 | Group Id: EG000
10625 | Num Events: 5
10626 | Num Affected: 5
10627 | Num At Risk: 516
10628 |
10629 | ##### Stats
10630 | Group Id: EG001
10631 | Num Events: 5
10632 | Num Affected: 5
10633 | Num At Risk: 532
10634 |
10635 | #### Serious Events
10636 | Term: Pulmonary embolism
10637 | Organ System: Respiratory, thoracic and mediastinal disorders
10638 | Source Vocabulary: MedDRA (23.0)
10639 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10640 |
10641 | ##### Stats
10642 | Group Id: EG000
10643 | Num Events: 4
10644 | Num Affected: 4
10645 | Num At Risk: 516
10646 |
10647 | ##### Stats
10648 | Group Id: EG001
10649 | Num Events: 5
10650 | Num Affected: 5
10651 | Num At Risk: 532
10652 |
10653 | #### Serious Events
10654 | Term: Hypoxia
10655 | Organ System: Respiratory, thoracic and mediastinal disorders
10656 | Source Vocabulary: MedDRA (23.0)
10657 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10658 |
10659 | ##### Stats
10660 | Group Id: EG000
10661 | Num Events: 4
10662 | Num Affected: 4
10663 | Num At Risk: 516
10664 |
10665 | ##### Stats
10666 | Group Id: EG001
10667 | Num Events: 4
10668 | Num Affected: 4
10669 | Num At Risk: 532
10670 |
10671 | #### Serious Events
10672 | Term: Pneumonia aspiration
10673 | Organ System: Respiratory, thoracic and mediastinal disorders
10674 | Source Vocabulary: MedDRA (23.0)
10675 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10676 |
10677 | ##### Stats
10678 | Group Id: EG000
10679 | Num Events: 2
10680 | Num Affected: 2
10681 | Num At Risk: 516
10682 |
10683 | ##### Stats
10684 | Group Id: EG001
10685 | Num Events: 4
10686 | Num Affected: 4
10687 | Num At Risk: 532
10688 |
10689 | #### Serious Events
10690 | Term: Dyspnoea
10691 | Organ System: Respiratory, thoracic and mediastinal disorders
10692 | Source Vocabulary: MedDRA (23.0)
10693 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10694 |
10695 | ##### Stats
10696 | Group Id: EG000
10697 | Num Events: 1
10698 | Num Affected: 1
10699 | Num At Risk: 516
10700 |
10701 | ##### Stats
10702 | Group Id: EG001
10703 | Num Events: 3
10704 | Num Affected: 3
10705 | Num At Risk: 532
10706 |
10707 | #### Serious Events
10708 | Term: Respiratory disorder
10709 | Organ System: Respiratory, thoracic and mediastinal disorders
10710 | Source Vocabulary: MedDRA (23.0)
10711 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10712 |
10713 | ##### Stats
10714 | Group Id: EG000
10715 | Num Events: 2
10716 | Num Affected: 2
10717 | Num At Risk: 516
10718 |
10719 | ##### Stats
10720 | Group Id: EG001
10721 | Num Events: 0
10722 | Num Affected: 0
10723 | Num At Risk: 532
10724 |
10725 | #### Serious Events
10726 | Term: Chronic respiratory failure
10727 | Organ System: Respiratory, thoracic and mediastinal disorders
10728 | Source Vocabulary: MedDRA (23.0)
10729 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10730 |
10731 | ##### Stats
10732 | Group Id: EG000
10733 | Num Events: 0
10734 | Num Affected: 0
10735 | Num At Risk: 516
10736 |
10737 | ##### Stats
10738 | Group Id: EG001
10739 | Num Events: 1
10740 | Num Affected: 1
10741 | Num At Risk: 532
10742 |
10743 | #### Serious Events
10744 | Term: Haemoptysis
10745 | Organ System: Respiratory, thoracic and mediastinal disorders
10746 | Source Vocabulary: MedDRA (23.0)
10747 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10748 |
10749 | ##### Stats
10750 | Group Id: EG000
10751 | Num Events: 0
10752 | Num Affected: 0
10753 | Num At Risk: 516
10754 |
10755 | ##### Stats
10756 | Group Id: EG001
10757 | Num Events: 1
10758 | Num Affected: 1
10759 | Num At Risk: 532
10760 |
10761 | #### Serious Events
10762 | Term: Pulmonary haemorrhage
10763 | Organ System: Respiratory, thoracic and mediastinal disorders
10764 | Source Vocabulary: MedDRA (23.0)
10765 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10766 |
10767 | ##### Stats
10768 | Group Id: EG000
10769 | Num Events: 0
10770 | Num Affected: 0
10771 | Num At Risk: 516
10772 |
10773 | ##### Stats
10774 | Group Id: EG001
10775 | Num Events: 1
10776 | Num Affected: 1
10777 | Num At Risk: 532
10778 |
10779 | #### Serious Events
10780 | Term: Subcutaneous emphysema
10781 | Organ System: Skin and subcutaneous tissue disorders
10782 | Source Vocabulary: MedDRA (23.0)
10783 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10784 |
10785 | ##### Stats
10786 | Group Id: EG000
10787 | Num Events: 0
10788 | Num Affected: 0
10789 | Num At Risk: 516
10790 |
10791 | ##### Stats
10792 | Group Id: EG001
10793 | Num Events: 1
10794 | Num Affected: 1
10795 | Num At Risk: 532
10796 |
10797 | #### Serious Events
10798 | Term: Endotracheal intubation
10799 | Organ System: Surgical and medical procedures
10800 | Source Vocabulary: MedDRA (23.0)
10801 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10802 |
10803 | ##### Stats
10804 | Group Id: EG000
10805 | Num Events: 9
10806 | Num Affected: 9
10807 | Num At Risk: 516
10808 |
10809 | ##### Stats
10810 | Group Id: EG001
10811 | Num Events: 6
10812 | Num Affected: 6
10813 | Num At Risk: 532
10814 |
10815 | #### Serious Events
10816 | Term: Mechanical ventilation
10817 | Organ System: Surgical and medical procedures
10818 | Source Vocabulary: MedDRA (23.0)
10819 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10820 |
10821 | ##### Stats
10822 | Group Id: EG000
10823 | Num Events: 3
10824 | Num Affected: 3
10825 | Num At Risk: 516
10826 |
10827 | ##### Stats
10828 | Group Id: EG001
10829 | Num Events: 1
10830 | Num Affected: 1
10831 | Num At Risk: 532
10832 |
10833 | #### Serious Events
10834 | Term: Hypotension
10835 | Organ System: Vascular disorders
10836 | Source Vocabulary: MedDRA (23.0)
10837 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10838 |
10839 | ##### Stats
10840 | Group Id: EG000
10841 | Num Events: 7
10842 | Num Affected: 7
10843 | Num At Risk: 516
10844 |
10845 | ##### Stats
10846 | Group Id: EG001
10847 | Num Events: 4
10848 | Num Affected: 4
10849 | Num At Risk: 532
10850 |
10851 | #### Serious Events
10852 | Term: Shock
10853 | Organ System: Vascular disorders
10854 | Source Vocabulary: MedDRA (23.0)
10855 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10856 |
10857 | ##### Stats
10858 | Group Id: EG000
10859 | Num Events: 4
10860 | Num Affected: 4
10861 | Num At Risk: 516
10862 |
10863 | ##### Stats
10864 | Group Id: EG001
10865 | Num Events: 5
10866 | Num Affected: 5
10867 | Num At Risk: 532
10868 |
10869 | #### Serious Events
10870 | Term: Deep vein thrombosis
10871 | Organ System: Vascular disorders
10872 | Source Vocabulary: MedDRA (23.0)
10873 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10874 |
10875 | ##### Stats
10876 | Group Id: EG000
10877 | Num Events: 1
10878 | Num Affected: 1
10879 | Num At Risk: 516
10880 |
10881 | ##### Stats
10882 | Group Id: EG001
10883 | Num Events: 1
10884 | Num Affected: 1
10885 | Num At Risk: 532
10886 |
10887 | #### Serious Events
10888 | Term: Embolism venous
10889 | Organ System: Vascular disorders
10890 | Source Vocabulary: MedDRA (23.0)
10891 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10892 |
10893 | ##### Stats
10894 | Group Id: EG000
10895 | Num Events: 0
10896 | Num Affected: 0
10897 | Num At Risk: 516
10898 |
10899 | ##### Stats
10900 | Group Id: EG001
10901 | Num Events: 1
10902 | Num Affected: 1
10903 | Num At Risk: 532
10904 |
10905 | #### Serious Events
10906 | Term: Peripheral artery occlusion
10907 | Organ System: Vascular disorders
10908 | Source Vocabulary: MedDRA (23.0)
10909 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10910 |
10911 | ##### Stats
10912 | Group Id: EG000
10913 | Num Events: 0
10914 | Num Affected: 0
10915 | Num At Risk: 516
10916 |
10917 | ##### Stats
10918 | Group Id: EG001
10919 | Num Events: 1
10920 | Num Affected: 1
10921 | Num At Risk: 532
10922 |
10923 | #### Serious Events
10924 | Term: Shock haemorrhagic
10925 | Organ System: Vascular disorders
10926 | Source Vocabulary: MedDRA (23.0)
10927 | Assessment Type: NON_SYSTEMATIC_ASSESSMENT
10928 |
10929 | ##### Stats
10930 | Group Id: EG000
10931 | Num Events: 0
10932 | Num Affected: 0
10933 | Num At Risk: 516
10934 |
10935 | ##### Stats
10936 | Group Id: EG001
10937 | Num Events: 1
10938 | Num Affected: 1
10939 | Num At Risk: 532
10940 |
10941 | #### Other Events
10942 | Term: Glomerular filtration rate decreased
10943 | Organ System: Investigations
10944 | Source Vocabulary: MedDRA (23.0)
10945 | Assessment Type: SYSTEMATIC_ASSESSMENT
10946 |
10947 | ##### Stats
10948 | Group Id: EG000
10949 | Num Events: 81
10950 | Num Affected: 74
10951 | Num At Risk: 516
10952 |
10953 | ##### Stats
10954 | Group Id: EG001
10955 | Num Events: 59
10956 | Num Affected: 55
10957 | Num At Risk: 532
10958 |
10959 | #### Other Events
10960 | Term: Haemoglobin decreased
10961 | Organ System: Investigations
10962 | Source Vocabulary: MedDRA (23.0)
10963 | Assessment Type: SYSTEMATIC_ASSESSMENT
10964 |
10965 | ##### Stats
10966 | Group Id: EG000
10967 | Num Events: 69
10968 | Num Affected: 62
10969 | Num At Risk: 516
10970 |
10971 | ##### Stats
10972 | Group Id: EG001
10973 | Num Events: 51
10974 | Num Affected: 48
10975 | Num At Risk: 532
10976 |
10977 | #### Other Events
10978 | Term: Lymphocyte count decreased
10979 | Organ System: Investigations
10980 | Source Vocabulary: MedDRA (23.0)
10981 | Assessment Type: SYSTEMATIC_ASSESSMENT
10982 |
10983 | ##### Stats
10984 | Group Id: EG000
10985 | Num Events: 63
10986 | Num Affected: 54
10987 | Num At Risk: 516
10988 |
10989 | ##### Stats
10990 | Group Id: EG001
10991 | Num Events: 56
10992 | Num Affected: 44
10993 | Num At Risk: 532
10994 |
10995 | #### Other Events
10996 | Term: Anaemia
10997 | Organ System: Blood and lymphatic system disorders
10998 | Source Vocabulary: MedDRA (23.0)
10999 | Assessment Type: SYSTEMATIC_ASSESSMENT
11000 |
11001 | ##### Stats
11002 | Group Id: EG000
11003 | Num Events: 58
11004 | Num Affected: 52
11005 | Num At Risk: 516
11006 |
11007 | ##### Stats
11008 | Group Id: EG001
11009 | Num Events: 52
11010 | Num Affected: 42
11011 | Num At Risk: 532
11012 |
11013 | #### Other Events
11014 | Term: Pyrexia
11015 | Organ System: General disorders
11016 | Source Vocabulary: MedDRA (23.0)
11017 | Assessment Type: SYSTEMATIC_ASSESSMENT
11018 |
11019 | ##### Stats
11020 | Group Id: EG000
11021 | Num Events: 37
11022 | Num Affected: 32
11023 | Num At Risk: 516
11024 |
11025 | ##### Stats
11026 | Group Id: EG001
11027 | Num Events: 52
11028 | Num Affected: 38
11029 | Num At Risk: 532
11030 |
11031 | #### Other Events
11032 | Term: Hyperglycaemia
11033 | Organ System: Metabolism and nutrition disorders
11034 | Source Vocabulary: MedDRA (23.0)
11035 | Assessment Type: SYSTEMATIC_ASSESSMENT
11036 |
11037 | ##### Stats
11038 | Group Id: EG000
11039 | Num Events: 43
11040 | Num Affected: 34
11041 | Num At Risk: 516
11042 |
11043 | ##### Stats
11044 | Group Id: EG001
11045 | Num Events: 36
11046 | Num Affected: 34
11047 | Num At Risk: 532
11048 |
11049 | #### Other Events
11050 | Term: Blood creatinine increased
11051 | Organ System: Investigations
11052 | Source Vocabulary: MedDRA (23.0)
11053 | Assessment Type: SYSTEMATIC_ASSESSMENT
11054 |
11055 | ##### Stats
11056 | Group Id: EG000
11057 | Num Events: 41
11058 | Num Affected: 36
11059 | Num At Risk: 516
11060 |
11061 | ##### Stats
11062 | Group Id: EG001
11063 | Num Events: 33
11064 | Num Affected: 31
11065 | Num At Risk: 532
11066 |
11067 | #### Other Events
11068 | Term: Blood glucose increased
11069 | Organ System: Investigations
11070 | Source Vocabulary: MedDRA (23.0)
11071 | Assessment Type: SYSTEMATIC_ASSESSMENT
11072 |
11073 | ##### Stats
11074 | Group Id: EG000
11075 | Num Events: 31
11076 | Num Affected: 27
11077 | Num At Risk: 516
11078 |
11079 | ##### Stats
11080 | Group Id: EG001
11081 | Num Events: 45
11082 | Num Affected: 39
11083 | Num At Risk: 532
11084 |
11085 | #### Other Events
11086 | Term: Aspartate aminotransferase increased
11087 | Organ System: Investigations
11088 | Source Vocabulary: MedDRA (23.0)
11089 | Assessment Type: SYSTEMATIC_ASSESSMENT
11090 |
11091 | ##### Stats
11092 | Group Id: EG000
11093 | Num Events: 35
11094 | Num Affected: 33
11095 | Num At Risk: 516
11096 |
11097 | ##### Stats
11098 | Group Id: EG001
11099 | Num Events: 19
11100 | Num Affected: 18
11101 | Num At Risk: 532
11102 |
11103 | #### Other Events
11104 | Term: Lymphopenia
11105 | Organ System: Blood and lymphatic system disorders
11106 | Source Vocabulary: MedDRA (23.0)
11107 | Assessment Type: SYSTEMATIC_ASSESSMENT
11108 |
11109 | ##### Stats
11110 | Group Id: EG000
11111 | Num Events: 34
11112 | Num Affected: 30
11113 | Num At Risk: 516
11114 |
11115 | ##### Stats
11116 | Group Id: EG001
11117 | Num Events: 15
11118 | Num Affected: 13
11119 | Num At Risk: 532
11120 |
11121 | ### More Info Module
11122 |
11123 | #### Certain Agreement
11124 | Pi Sponsor Employee: False
11125 | Restriction Type: LTE60
11126 | Restrictive Agreement: True
11127 |
11128 | #### Point Of Contact
11129 | Title: John Beigel, MD
11130 | Organization: Organization:NIAID
11131 | Email: [email protected]
11132 | Phone: 3014519881
11133 |
11134 | ## Document Section
11135 |
11136 | ### Large Document Module
11137 |
11138 | #### Large Docs
11139 | Type Abbrev: Prot
11140 | Has Protocol: True
11141 | Has Sap: False
11142 | Has Icf: False
11143 | Label: Study Protocol
11144 | Date: 2020-04-02
11145 | Upload Date: 2020-09-16T16:07
11146 | Filename: Prot_001.pdf
11147 | Size: 846604
11148 |
11149 | #### Large Docs
11150 | Type Abbrev: SAP
11151 | Has Protocol: False
11152 | Has Sap: True
11153 | Has Icf: False
11154 | Label: Statistical Analysis Plan
11155 | Date: 2020-05-29
11156 | Upload Date: 2020-09-16T16:08
11157 | Filename: SAP_002.pdf
11158 | Size: 2793155
11159 |
11160 | #### Large Docs
11161 | Type Abbrev: ICF
11162 | Has Protocol: False
11163 | Has Sap: False
11164 | Has Icf: True
11165 | Label: Informed Consent Form
11166 | Date: 2020-03-04
11167 | Upload Date: 2020-07-20T15:36
11168 | Filename: ICF_000.pdf
11169 | Size: 281581
11170 |
11171 | ## Derived Section
11172 |
11173 | ### Misc Info Module
11174 | Version Holder: 2025-03-21
11175 |
11176 | ### Condition Browse Module
11177 |
11178 | #### Meshes
11179 | Id: D000086382
11180 | Term: COVID-19
11181 |
11182 | #### Ancestors
11183 | Id: D011024
11184 | Term: Pneumonia, Viral
11185 |
11186 | #### Ancestors
11187 | Id: D011014
11188 | Term: Pneumonia
11189 |
11190 | #### Ancestors
11191 | Id: D012141
11192 | Term: Respiratory Tract Infections
11193 |
11194 | #### Ancestors
11195 | Id: D007239
11196 | Term: Infections
11197 |
11198 | #### Ancestors
11199 | Id: D014777
11200 | Term: Virus Diseases
11201 |
11202 | #### Ancestors
11203 | Id: D018352
11204 | Term: Coronavirus Infections
11205 |
11206 | #### Ancestors
11207 | Id: D003333
11208 | Term: Coronaviridae Infections
11209 |
11210 | #### Ancestors
11211 | Id: D030341
11212 | Term: Nidovirales Infections
11213 |
11214 | #### Ancestors
11215 | Id: D012327
11216 | Term: RNA Virus Infections
11217 |
11218 | #### Ancestors
11219 | Id: D008171
11220 | Term: Lung Diseases
11221 |
11222 | #### Ancestors
11223 | Id: D012140
11224 | Term: Respiratory Tract Diseases
11225 |
11226 | #### Browse Leaves
11227 | Id: M2561
11228 | Name: COVID-19
11229 | As Found: COVID-19
11230 | Relevance: HIGH
11231 |
11232 | #### Browse Leaves
11233 | Id: M20490
11234 | Name: Coronavirus Infections
11235 | Relevance: LOW
11236 |
11237 | #### Browse Leaves
11238 | Id: M13904
11239 | Name: Pneumonia
11240 | Relevance: LOW
11241 |
11242 | #### Browse Leaves
11243 | Id: M13914
11244 | Name: Pneumonia, Viral
11245 | Relevance: LOW
11246 |
11247 | #### Browse Leaves
11248 | Id: M10283
11249 | Name: Infections
11250 | Relevance: LOW
11251 |
11252 | #### Browse Leaves
11253 | Id: M6368
11254 | Name: Communicable Diseases
11255 | Relevance: LOW
11256 |
11257 | #### Browse Leaves
11258 | Id: M14978
11259 | Name: Respiratory Tract Infections
11260 | Relevance: LOW
11261 |
11262 | #### Browse Leaves
11263 | Id: M17522
11264 | Name: Virus Diseases
11265 | Relevance: LOW
11266 |
11267 | #### Browse Leaves
11268 | Id: M6555
11269 | Name: Coronaviridae Infections
11270 | Relevance: LOW
11271 |
11272 | #### Browse Leaves
11273 | Id: M23685
11274 | Name: Nidovirales Infections
11275 | Relevance: LOW
11276 |
11277 | #### Browse Leaves
11278 | Id: M15149
11279 | Name: RNA Virus Infections
11280 | Relevance: LOW
11281 |
11282 | #### Browse Leaves
11283 | Id: M11168
11284 | Name: Lung Diseases
11285 | Relevance: LOW
11286 |
11287 | #### Browse Leaves
11288 | Id: M14977
11289 | Name: Respiratory Tract Diseases
11290 | Relevance: LOW
11291 |
11292 | #### Browse Branches
11293 | Abbrev: BC01
11294 | Name: Infections
11295 |
11296 | #### Browse Branches
11297 | Abbrev: BC08
11298 | Name: Respiratory Tract (Lung and Bronchial) Diseases
11299 |
11300 | #### Browse Branches
11301 | Abbrev: All
11302 | Name: All Conditions
11303 |
11304 | #### Browse Branches
11305 | Abbrev: BC23
11306 | Name: Symptoms and General Pathology
11307 |
11308 | ### Intervention Browse Module
11309 |
11310 | #### Meshes
11311 | Id: C000606551
11312 | Term: Remdesivir
11313 |
11314 | #### Ancestors
11315 | Id: D000963
11316 | Term: Antimetabolites
11317 |
11318 | #### Ancestors
11319 | Id: D045504
11320 | Term: Molecular Mechanisms of Pharmacological Action
11321 |
11322 | #### Ancestors
11323 | Id: D000998
11324 | Term: Antiviral Agents
11325 |
11326 | #### Ancestors
11327 | Id: D000890
11328 | Term: Anti-Infective Agents
11329 |
11330 | #### Browse Leaves
11331 | Id: M6263
11332 | Name: Coal Tar
11333 | Relevance: LOW
11334 |
11335 | #### Browse Leaves
11336 | Id: M341627
11337 | Name: Remdesivir
11338 | As Found: Isoniazid
11339 | Relevance: HIGH
11340 |
11341 | #### Browse Leaves
11342 | Id: M341633
11343 | Name: GS-441524
11344 | Relevance: LOW
11345 |
11346 | #### Browse Leaves
11347 | Id: M107438
11348 | Name: Betadex
11349 | Relevance: LOW
11350 |
11351 | #### Browse Leaves
11352 | Id: M4281
11353 | Name: Antimetabolites
11354 | Relevance: LOW
11355 |
11356 | #### Browse Leaves
11357 | Id: M4314
11358 | Name: Antiviral Agents
11359 | Relevance: LOW
11360 |
11361 | #### Browse Leaves
11362 | Id: M4214
11363 | Name: Anti-Infective Agents
11364 | Relevance: LOW
11365 |
11366 | #### Browse Branches
11367 | Abbrev: Derm
11368 | Name: Dermatologic Agents
11369 |
11370 | #### Browse Branches
11371 | Abbrev: All
11372 | Name: All Drugs and Chemicals
11373 |
11374 | #### Browse Branches
11375 | Abbrev: Infe
11376 | Name: Anti-Infective Agents
11377 |
```