This is page 13 of 15. Use http://codebase.md/genomoncology/biomcp?lines=false&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:
--------------------------------------------------------------------------------
```
Next Page Token: NF0g5JCEk_IgxQc
# Studies
Has Results: True
## Protocol Section
### Identification Module
Nct Id: NCT04280705
Brief Title: Adaptive COVID-19 Treatment Trial (ACTT)
Official Title:
A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the
Safety and Efficacy of Investigational Therapeutics for the Treatment of
COVID-19 in Hospitalized Adults
#### Org Study Id Info
Id: 20-0006
#### Organization
Full Name: National Institute of Allergy and Infectious Diseases (NIAID)
Class: NIH
### Status Module
Status Verified Date: 2020-04
Overall Status: COMPLETED
Study First Submit Date: 2020-02-20
Study First Submit Qc Date: 2020-02-20
Results First Submit Date: 2020-09-16
Results First Submit Qc Date: 2020-09-22
Last Update Submit Date: 2022-03-09
#### Expanded Access Info
Has Expanded Access: False
#### Start Date Struct
Date: 2020-02-21
Type: ACTUAL
#### Primary Completion Date Struct
Date: 2020-05-21
Type: ACTUAL
#### Completion Date Struct
Date: 2020-05-21
Type: ACTUAL
#### Study First Post Date Struct
Date: 2020-02-21
Type: ACTUAL
#### Results First Post Date Struct
Date: 2020-09-25
Type: ACTUAL
#### Last Update Post Date Struct
Date: 2022-03-14
Type: ACTUAL
### Sponsor Collaborators Module
#### Responsible Party
Type: SPONSOR
#### Lead Sponsor
Name: National Institute of Allergy and Infectious Diseases (NIAID)
Class: NIH
### Oversight Module
Is Fda Regulated Drug: True
Is Fda Regulated Device: False
Is Us Export: False
### Description Module
Brief Summary:
This study is an adaptive, randomized, double-blind, placebo-controlled
trial to evaluate the safety and efficacy of novel therapeutic agents in
hospitalized adults diagnosed with COVID-19. The study is a multicenter
trial that will be conducted in up to approximately 100 sites globally.
The study will compare different investigational therapeutic agents to a
control arm. There will be interim monitoring to introduce new arms and
allow early stopping for futility, efficacy, or safety. If one therapy
proves to be efficacious, then this treatment may become the control arm
for comparison(s) with new experimental treatment(s). Any such change
would be accompanied by an updated sample size. Because background
standards of supportive care may evolve/improve over time as more is
learned about successful management of COVID-19, comparisons of safety
and efficacy will be based on data from concurrently randomized
subjects. An independent Data and Safety Monitoring Board (DSMB) will
actively monitor interim data to make recommendations about early study
closure or changes to study arms. To evaluate the clinical efficacy, as
assessed by time to recovery, of different investigational therapeutics
as compared to the control arm.
Detailed Description:
This study is an adaptive, randomized, double-blind, placebo-controlled
trial to evaluate the safety and efficacy of novel therapeutic agents in
hospitalized adults diagnosed with COVID-19. The study is a multicenter
trial that will be conducted in up to approximately 100 sites globally.
The study will compare different investigational therapeutic agents to a
control arm. There will be interim monitoring to introduce new arms and
allow early stopping for futility, efficacy, or safety. If one therapy
proves to be efficacious, then this treatment may become the control arm
for comparison(s) with new experimental treatment(s). Any such change
would be accompanied by an updated sample size. Because background
standards of supportive care may evolve/improve over time as more is
learned about successful management of COVID-19, comparisons of safety
and efficacy will be based on data from concurrently randomized
subjects. An independent Data and Safety Monitoring Board (DSMB) will
actively monitor interim data to make recommendations about early study
closure or changes to study arms.
The initial sample size is projected to be 572 subjects to achieve 400
subjects with a "recovered" status (per the primary objective). The
primary analysis will be based on those subjects enrolled in order to
400 recoveries. An additional analysis of the moderate severity subgroup
(those with baseline status of "Hospitalized, requiring supplemental
oxygen" or "Hospitalized, not requiring supplemental oxygen - requiring
ongoing medical care") is also of public health importance. Hence,
enrollment will be permitted until the date of April 20, 2020 to ensure
400 recoveries and provide additional data about this important
subgroup. With recent enrollment rates, the total sample size may be 600
to over 800.
Subjects will be assessed daily while hospitalized. If the subjects are
discharged from the hospital, they will have a study visit at Days 15,
22, and 29 as an outpatient. For discharged subjects, it is preferred
that the Day 15 and 29 visits are in person to obtain safety laboratory
tests and OP swab and blood (serum only) samples for secondary research
as well as clinical outcome data. However, infection control or other
restrictions may limit the ability of the subject to return to the
clinic. In this case, Day 15 and 29 visits may be conducted by phone,
and only clinical data will be obtained. The Day 22 visit does not have
laboratory tests or collection of samples and may also be conducted by
phone.
All subjects will undergo a series of efficacy, safety, and laboratory
assessments. Safety laboratory tests and blood (serum and plasma)
research samples and oropharyngeal (OP) swabs will be obtained on Days 1
(prior to infusion) and Days 3, 5, 8, and 11 (while hospitalized). OP
swabs and blood (serum only) plus safety laboratory tests will be
collected on Day 15 and 29 (if the subject attends an in-person visit or
are still hospitalized).
The primary outcome is time to recovery by Day 29. A key secondary
outcome evaluates treatment-related improvements in the 8-point ordinal
scale at Day 15. As little is known about the clinical course of
COVID-19, a pilot study will be used for a blinded sample size
reassessment.
Contacts:
20-0006 Central Contact
Telephone: 1 (301) 7617948
Email: [email protected]
### Conditions Module
Conditions: COVID-19
Keywords:
- Adaptive
- COVID-19
- Efficacy
- Multicenter
- novel coronavirus
- Safety
- ACTT
### Design Module
Study Type: INTERVENTIONAL
#### Design Info
Allocation: RANDOMIZED
Intervention Model: PARALLEL
Primary Purpose: TREATMENT
##### Masking Info
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
#### Enrollment Info
Count: 1062
Type: ACTUAL
Phases: PHASE3
### Arms Interventions Module
#### Arm Groups
Label: Placebo
Type: PLACEBO_COMPARATOR
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course. n=286.
Intervention Names: Other: Placebo
#### Arm Groups
Label: Remdesivir
Type: EXPERIMENTAL
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course. n=286.
Intervention Names: Drug: Remdesivir
#### Interventions
Type: OTHER
Name: Placebo
Description:
The supplied placebo lyophilized formulation is identical in physical
appearance to the active lyophilized formulation and contains the same
inactive ingredients. Alternatively, a placebo of normal saline of equal
volume may be given if there are limitations on matching placebo
supplies.
Arm Group Labels: Placebo
#### Interventions
Type: DRUG
Name: Remdesivir
Description:
Drug Remdesivir is a single diastereomer monophosphoramidate prodrug
designed for the intracellular delivery of a modified adenine nucleoside
analog GS-441524. In addition to the active ingredient, the lyophilized
formulation of Remdesivir contains the following inactive ingredients:
water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD),
and hydrochloric acid and/or sodium hydroxide.
Arm Group Labels: Remdesivir
### Outcomes Module
#### Primary Outcomes
Measure: Time to Recovery
Description:
Day of recovery is defined as the first day on which the subject
satisfies one of the following three categories from the ordinal scale:
1) Hospitalized, not requiring supplemental oxygen - no longer requires
ongoing medical care; 2) Not hospitalized, limitation on activities
and/or requiring home oxygen; 3) Not hospitalized, no limitations on
activities.
Time Frame: Day 1 through Day 29
#### Primary Outcomes
Measure: Time to Recovery by Race
Description:
Day of recovery is defined as the first day on which the subject
satisfies one of the following three categories from the ordinal scale:
1) Hospitalized, not requiring supplemental oxygen - no longer requires
ongoing medical care; 2) Not hospitalized, limitation on activities
and/or requiring home oxygen; 3) Not hospitalized, no limitations on
activities.
Time Frame: Day 1 through Day 29
#### Primary Outcomes
Measure: Time to Recovery by Ethnicity
Description:
Day of recovery is defined as the first day on which the subject
satisfies one of the following three categories from the ordinal scale:
1) Hospitalized, not requiring supplemental oxygen - no longer requires
ongoing medical care; 2) Not hospitalized, limitation on activities
and/or requiring home oxygen; 3) Not hospitalized, no limitations on
activities.
Time Frame: Day 1 through Day 29
#### Primary Outcomes
Measure: Time to Recovery by Sex
Description:
Day of recovery is defined as the first day on which the subject
satisfies one of the following three categories from the ordinal scale:
1) Hospitalized, not requiring supplemental oxygen - no longer requires
ongoing medical care; 2) Not hospitalized, limitation on activities
and/or requiring home oxygen; 3) Not hospitalized, no limitations on
activities.
Time Frame: Day 1 through Day 29
#### Secondary Outcomes
Measure: Change From Baseline in Alanine Transaminase (ALT)
Description:
Blood to evaluate ALT was collected at Days 1, 3, 5, 8, and 11 while
participants were inpatient, and at Days 15 and 29, with the Day 1
assessment serving as baseline. Participants who had been discharged had
blood collected if infection control measures allowed for in-person
visits after discharge.
Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
#### Secondary Outcomes
Measure: Change From Baseline in Aspartate Transaminase (AST)
Description:
Blood to evaluate AST was collected at Days 1, 3, 5, 8, and 11 while
participants were inpatient, and at Days 15 and 29, with the Day 1
assessment serving as baseline. Participants who had been discharged had
blood collected if infection control measures allowed for in-person
visits after discharge.
Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
#### Secondary Outcomes
Measure: Change From Baseline in Creatinine
Description:
Blood to evaluate serum creatinine was collected at Days 1, 3, 5, 8, and
11 while participants were inpatient, and at Days 15 and 29, with the
Day 1 assessment serving as baseline. Participants who had been
discharged had blood collected if infection control measures allowed for
in-person visits after discharge.
Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
#### Secondary Outcomes
Measure: Change From Baseline in Glucose
Description:
Blood to evaluate serum glucose was collected at Days 1, 3, 5, 8, and 11
while participants were inpatient, and at Days 15 and 29, with the Day 1
assessment serving as baseline. Participants who had been discharged had
blood collected if infection control measures allowed for in-person
visits after discharge.
Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
#### Secondary Outcomes
Measure: Change From Baseline in Hemoglobin
Description:
Blood to evaluate hemoglobin was collected at Days 1, 3, 5, 8, and 11
while participants were inpatient, and at Days 15 and 29, with the Day 1
assessment serving as baseline. Participants who had been discharged had
blood collected if infection control measures allowed for in-person
visits after discharge.
Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
#### Secondary Outcomes
Measure: Change From Baseline in Platelets
Description:
Blood to evaluate platelets was collected at Days 1, 3, 5, 8, and 11
while participants were inpatient, and at Days 15 and 29, with the Day 1
assessment serving as baseline. Participants who had been discharged had
blood collected if infection control measures allowed for in-person
visits after discharge.
Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
#### Secondary Outcomes
Measure: Change From Baseline in Prothrombin Time (PT)
Description:
Blood to evaluate PT was collected at Days 1, 3, 5, 8, and 11 while
participants were inpatient, and at Days 15 and 29, with the Day 1
assessment serving as baseline. Participants who had been discharged had
blood collected if infection control measures allowed for in-person
visits after discharge.
Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
#### Secondary Outcomes
Measure: Change From Baseline in Total Bilirubin
Description:
Blood to evaluate total bilirubin was collected at Days 1, 3, 5, 8, and
11 while participants were inpatient, and at Days 15 and 29, with the
Day 1 assessment serving as baseline. Participants who had been
discharged had blood collected if infection control measures allowed for
in-person visits after discharge.
Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
#### Secondary Outcomes
Measure: Change From Baseline in White Blood Cell Count (WBC)
Description:
Blood to evaluate WBC was collected at Days 1, 3, 5, 8, and 11 while
participants were inpatient, and at Days 15 and 29, with the Day 1
assessment serving as baseline. Participants who had been discharged had
blood collected if infection control measures allowed for in-person
visits after discharge.
Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
#### Secondary Outcomes
Measure: Change From Baseline in Neutrophils
Description:
Blood to evaluate neutrophils was collected at Days 1, 3, 5, 8, and 11
while participants were inpatient, and at Days 15 and 29, with the Day 1
assessment serving as baseline. Participants who had been discharged had
blood collected if infection control measures allowed for in-person
visits after discharge.
Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
#### Secondary Outcomes
Measure: Change From Baseline in Lymphocytes
Description:
Blood to evaluate lymphocytes was collected at Days 1, 3, 5, 8, and 11
while participants were inpatient, and at Days 15 and 29, with the Day 1
assessment serving as baseline. Participants who had been discharged had
blood collected if infection control measures allowed for in-person
visits after discharge.
Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
#### Secondary Outcomes
Measure: Change From Baseline in Monocytes
Description:
Blood to evaluate monocytes was collected at Days 1, 3, 5, 8, and 11
while participants were inpatient, and at Days 15 and 29, with the Day 1
assessment serving as baseline. Participants who had been discharged had
blood collected if infection control measures allowed for in-person
visits after discharge.
Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
#### Secondary Outcomes
Measure: Change From Baseline in Basophils
Description:
Blood to evaluate basophils was collected at Days 1, 3, 5, 8, and 11
while participants were inpatient, and at Days 15 and 29, with the Day 1
assessment serving as baseline. Participants who had been discharged had
blood collected if infection control measures allowed for in-person
visits after discharge.
Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
#### Secondary Outcomes
Measure: Change From Baseline in Eosinophils
Description:
Blood to evaluate eosinophils was collected at Days 1, 3, 5, 8, and 11
while participants were inpatient, and at Days 15 and 29, with the Day 1
assessment serving as baseline. Participants who had been discharged had
blood collected if infection control measures allowed for in-person
visits after discharge.
Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
#### Secondary Outcomes
Measure: Change in National Early Warning Score (NEWS) From Baseline
Description:
The NEW score has demonstrated an ability to discriminate patients at
risk of poor outcomes. This score is based on 7 clinical parameters
(respiration rate, oxygen saturation, any supplemental oxygen,
temperature, systolic blood pressure, heart rate, level of
consciousness). The NEW Score is being used as an efficacy measure. The
minimum score is 0, representing the better outcome, and the maximum
value is 19, representing the worse outcome.
Time Frame: Days 1, 3, 5, 8, 11, 15, 22, and 29
#### Secondary Outcomes
Measure:
Percentage of Participants at Each Clinical Status Using Ordinal Scale
at Day 1
Description:
The ordinal scale is an assessment of the clinical status at the first
assessment of a given study day. The scale is as follows: 8) Death; 7)
Hospitalized, on invasive mechanical ventilation or extracorporeal
membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
ventilation or high flow oxygen devices; 5) Hospitalized, requiring
supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
- requiring ongoing medical care (COVID-19 related or otherwise); 3)
Hospitalized, not requiring supplemental oxygen - no longer requires
ongoing medical care; 2) Not hospitalized, limitation on activities
and/or requiring home oxygen; 1) Not hospitalized, no limitations on
activities.
Time Frame: Day 1
#### Secondary Outcomes
Measure:
Percentage of Participants at Each Clinical Status Using Ordinal Scale
at Day 3
Description:
The ordinal scale is an assessment of the clinical status at the first
assessment of a given study day. The scale is as follows: 8) Death; 7)
Hospitalized, on invasive mechanical ventilation or extracorporeal
membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
ventilation or high flow oxygen devices; 5) Hospitalized, requiring
supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
- requiring ongoing medical care (COVID-19 related or otherwise); 3)
Hospitalized, not requiring supplemental oxygen - no longer requires
ongoing medical care; 2) Not hospitalized, limitation on activities
and/or requiring home oxygen; 1) Not hospitalized, no limitations on
activities.
Time Frame: Day 3
#### Secondary Outcomes
Measure:
Percentage of Participants at Each Clinical Status Using Ordinal Scale
at Day 5
Description:
The ordinal scale is an assessment of the clinical status at the first
assessment of a given study day. The scale is as follows: 8) Death; 7)
Hospitalized, on invasive mechanical ventilation or extracorporeal
membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
ventilation or high flow oxygen devices; 5) Hospitalized, requiring
supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
- requiring ongoing medical care (COVID-19 related or otherwise); 3)
Hospitalized, not requiring supplemental oxygen - no longer requires
ongoing medical care; 2) Not hospitalized, limitation on activities
and/or requiring home oxygen; 1) Not hospitalized, no limitations on
activities.
Time Frame: Day 5
#### Secondary Outcomes
Measure:
Percentage of Participants at Each Clinical Status Using Ordinal Scale
at Day 8
Description:
The ordinal scale is an assessment of the clinical status at the first
assessment of a given study day. The scale is as follows: 8) Death; 7)
Hospitalized, on invasive mechanical ventilation or extracorporeal
membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
ventilation or high flow oxygen devices; 5) Hospitalized, requiring
supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
- requiring ongoing medical care (COVID-19 related or otherwise); 3)
Hospitalized, not requiring supplemental oxygen - no longer requires
ongoing medical care; 2) Not hospitalized, limitation on activities
and/or requiring home oxygen; 1) Not hospitalized, no limitations on
activities.
Time Frame: Day 8
#### Secondary Outcomes
Measure:
Percentage of Participants at Each Clinical Status Using Ordinal Scale
at Day 11
Description:
The ordinal scale is an assessment of the clinical status at the first
assessment of a given study day. The scale is as follows: 8) Death; 7)
Hospitalized, on invasive mechanical ventilation or extracorporeal
membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
ventilation or high flow oxygen devices; 5) Hospitalized, requiring
supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
- requiring ongoing medical care (COVID-19 related or otherwise); 3)
Hospitalized, not requiring supplemental oxygen - no longer requires
ongoing medical care; 2) Not hospitalized, limitation on activities
and/or requiring home oxygen; 1) Not hospitalized, no limitations on
activities.
Time Frame: Day 11
#### Secondary Outcomes
Measure:
Percentage of Participants at Each Clinical Status Using Ordinal Scale
at Day 15
Description:
The ordinal scale is an assessment of the clinical status at the first
assessment of a given study day. The scale is as follows: 8) Death; 7)
Hospitalized, on invasive mechanical ventilation or extracorporeal
membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
ventilation or high flow oxygen devices; 5) Hospitalized, requiring
supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
- requiring ongoing medical care (COVID-19 related or otherwise); 3)
Hospitalized, not requiring supplemental oxygen - no longer requires
ongoing medical care; 2) Not hospitalized, limitation on activities
and/or requiring home oxygen; 1) Not hospitalized, no limitations on
activities.
Time Frame: Day 15
#### Secondary Outcomes
Measure:
Percentage of Participants at Each Clinical Status Using Ordinal Scale
at Day 22
Description:
The ordinal scale is an assessment of the clinical status at the first
assessment of a given study day. The scale is as follows: 8) Death; 7)
Hospitalized, on invasive mechanical ventilation or extracorporeal
membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
ventilation or high flow oxygen devices; 5) Hospitalized, requiring
supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
- requiring ongoing medical care (COVID-19 related or otherwise); 3)
Hospitalized, not requiring supplemental oxygen - no longer requires
ongoing medical care; 2) Not hospitalized, limitation on activities
and/or requiring home oxygen; 1) Not hospitalized, no limitations on
activities.
Time Frame: Day 22
#### Secondary Outcomes
Measure:
Percentage of Participants at Each Clinical Status Using Ordinal Scale
at Day 29
Description:
The ordinal scale is an assessment of the clinical status at the first
assessment of a given study day. The scale is as follows: 8) Death; 7)
Hospitalized, on invasive mechanical ventilation or extracorporeal
membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
ventilation or high flow oxygen devices; 5) Hospitalized, requiring
supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
- requiring ongoing medical care (COVID-19 related or otherwise); 3)
Hospitalized, not requiring supplemental oxygen - no longer requires
ongoing medical care; 2) Not hospitalized, limitation on activities
and/or requiring home oxygen; 1) Not hospitalized, no limitations on
activities.
Time Frame: Day 29
#### Secondary Outcomes
Measure:
Percentage of Participants Reporting Grade 3 and 4 Clinical and/or
Laboratory Adverse Events (AEs)
Description:
Grade 3 AEs are defined as events that interrupt usual activities of
daily living, or significantly affects clinical status, or may require
intensive therapeutic intervention. Severe events are usually
incapacitating. Grade 4 AEs are defined as events that are potentially
life threatening.
Time Frame: Day 1 through Day 29
#### Secondary Outcomes
Measure: Percentage of Participants Reporting Serious Adverse Events (SAEs)
Description:
An SAE is defined as an AE or suspected adverse reaction is considered
serious if, in the view of either the investigator or the sponsor, it
results in death, a life-threatening AE, inpatient hospitalization or
prolongation of existing hospitalization, a persistent or significant
incapacity or substantial disruption of the ability to conduct normal
life functions, or a congenital anomaly/birth defect.
Time Frame: Day 1 through Day 29
#### Secondary Outcomes
Measure:
Percentage of Participants Discontinued or Temporarily Suspended From
Investigational Therapeutics
Description:
Participants may have been discontinued from investigational
therapeutics due to discharge or death. The halting or slowing of the
infusion for any reason was collected, as was missed doses in the series
of 10 doses.
Time Frame: Day 1 through Day 10
#### Secondary Outcomes
Measure: Duration of Hospitalization
Description:
Duration of hospitalization was determined two ways. The first includes
imputations for participants who died. The second method is restricted
to participants who did not die.
Time Frame: Day 1 through Day 29
#### Secondary Outcomes
Measure: Duration of New Non-invasive Ventilation or High Flow Oxygen Use
Description:
Duration of new non-invasive ventilation or high flow oxygen use was
measured in days among participants who were not on non-invasive
ventilation or high-flow oxygen use at baseline, determined two ways.
The first includes imputations for participants who died. The second
method is restricted to participants who did not die
Time Frame: Day 1 through Day 29
#### Secondary Outcomes
Measure: Duration of New Oxygen Use
Description:
Duration of new oxygen use was measured in days among participants who
were not on oxygen at baseline, determined two ways. The first includes
imputations for participants who died. The second method is restricted
to participants who did not die
.
Time Frame: Day 1 through Day 29
#### Secondary Outcomes
Measure:
Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO)
Use
Description:
Duration of new ventilator or ECMO use was measured in days among
participants who were not on a ventilator or ECMO at baseline,
determined two ways. The first includes imputations for participants who
died. The second method is restricted to participants who did not die
Time Frame: Day 1 through Day 29
#### Secondary Outcomes
Measure:
Percentage of Participants Requiring New Non-invasive Ventilation or
High-flow Oxygen Use
Description:
New non-invasive ventilation or high-flow oxygen use was determined as
the percentage of subject not on non-invasive ventilation or high-flow
oxygen at baseline.
Time Frame: Day 1 through Day 29
#### Secondary Outcomes
Measure: Percentage of Participants Requiring New Oxygen Use
Description:
The percentage of participants requiring new oxygen use was determined
as the percentage of participants not requiring oxygen at baseline
Time Frame: Day 1 through Day 29
#### Secondary Outcomes
Measure:
Percentage of Participants Requiring New Ventilator or Extracorporeal
Membrane Oxygenation (ECMO) Use
Description:
The percentage of participants requiring new ventilator or ECMO use was
determined as the percentage not on a ventilator or ECMO at baseline
Time Frame: Day 1 through Day 29
#### Secondary Outcomes
Measure: Mean Change in the Ordinal Scale
Description:
The ordinal scale is an assessment of the clinical status at the first
assessment of a given study day. The scale is as follows: 8) Death; 7)
Hospitalized, on invasive mechanical ventilation or extracorporeal
membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
ventilation or high flow oxygen devices; 5) Hospitalized, requiring
supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
- requiring ongoing medical care (COVID-19 related or otherwise); 3)
Hospitalized, not requiring supplemental oxygen - no longer requires
ongoing medical care; 2) Not hospitalized, limitation on activities
and/or requiring home oxygen; 1) Not hospitalized, no limitations on
activities. A positive change indicates a worsening and a negative
change is an improvement.
Time Frame: Day 1, 3, 5, 8, 11, 15, 22, and 29
#### Secondary Outcomes
Measure: 14-day Participant Mortality
Description:
The mortality rate was determined as the proportion of participants who
died by study Day 15.
Time Frame: Day 1 through Day 15
#### Secondary Outcomes
Measure: 29-day Participant Mortality
Description:
The mortality rate was determined as the proportion of participants who
died by study Day 29.
Time Frame: Day 1 through Day 29
#### Secondary Outcomes
Measure: Time to an Improvement by at Least One Category Using an Ordinal Scale
Description:
The ordinal scale is an assessment of the clinical status at the first
assessment of a given study day. The scale is as follows: 8) Death; 7)
Hospitalized, on invasive mechanical ventilation or extracorporeal
membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
ventilation or high flow oxygen devices; 5) Hospitalized, requiring
supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
- requiring ongoing medical care (COVID-19 related or otherwise); 3)
Hospitalized, not requiring supplemental oxygen - no longer requires
ongoing medical care; 2) Not hospitalized, limitation on activities
and/or requiring home oxygen; 1) Not hospitalized, no limitations on
activities. Time to improvement by at least one category was determined
for each participant
Time Frame: Day 1 through Day 29
#### Secondary Outcomes
Measure: Time to an Improvement of at Least Two Categories Using an Ordinal Scale
Description:
The ordinal scale is an assessment of the clinical status at the first
assessment of a given study day. The scale is as follows: 1) Death; 2)
Hospitalized, on invasive mechanical ventilation or extracorporeal
membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive
ventilation or high flow oxygen devices; 4) Hospitalized, requiring
supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen
- requiring ongoing medical care (COVID-19 related or otherwise); 6)
Hospitalized, not requiring supplemental oxygen - no longer requires
ongoing medical care; 7) Not hospitalized, limitation on activities
and/or requiring home oxygen; 8) Not hospitalized, no limitations on
activities. Time to improvement by at least two categories was
determined for each participant
Time Frame: Day 1 through Day 29
#### Secondary Outcomes
Measure:
Time to Discharge or to a NEWS of 2 or Less and Maintained for 24 Hours,
Whichever Occurs First
Description:
The NEW score has demonstrated an ability to discriminate patients at
risk of poor outcomes. This score is based on 7 clinical parameters
(respiration rate, oxygen saturation, any supplemental oxygen,
temperature, systolic blood pressure, heart rate, level of
consciousness). The NEW Score is being used as an efficacy measure. The
minimum score is 0, representing the better outcome, and the maximum
value is 19, representing the worse outcome. The time to discharge or a
NEWS of less than or equal to 2 was determined for each participant.
Time Frame: Day 1 through Day 29
### Eligibility Module
Eligibility Criteria:
Inclusion Criteria:
1. Admitted to a hospital with symptoms suggestive of COVID-19
infection.
2. Subject (or legally authorized representative) provides informed
consent prior to initiation of any study procedures.
3. Subject (or legally authorized representative) understands and agrees
to comply with planned study procedures.
4. Male or non-pregnant female adult \> / = 18 years of age at time of
enrollment.
5. Has laboratory-confirmed SARS-CoV-2 infection as determined by
polymerase chain reaction (PCR) or other commercial or public health
assay in any specimen, as documented by either or the following:
1. PCR positive in sample collected \< 72 hours prior to randomization;
OR
Exclusion Criteria:
2. PCR positive in sample collected \>/= 72 hours prior to
randomization, documented inability to obtain a repeat sample (e.g. due
to lack of testing supplies, limited testing capacity, results taking
\>24 hours, etc.) AND progressive disease suggestive of ongoing SARS-
CoV-2 infection.
6. Illness of any duration, and at least one of the following:
1. Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR
2. SpO2 \< / = 94% on room air, OR
3. Requiring supplemental oxygen, OR
4. Requiring mechanical ventilation.
7. Women of childbearing potential must agree to either abstinence or
use at least one primary form of contraception not including hormonal
contraception from the time of screening through Day 29.
8. Agrees to not participate in another clinical trial for the treatment
of COVID-19 or SARS-CoV-2 through Day 29.
Exclusion Criteria:
1. Alanine Transaminase (ALT) or Aspartate Transaminase (AST) \> 5 times
the upper limit of normal.
2. Estimated glomerular filtration rate (eGFR) \< 30 ml/min (including
patients receiving hemodialysis or hemofiltration).
3. Pregnancy or breast feeding.
4. Anticipated discharge from the hospital or transfer to another
hospital which is not a study site within 72 hours.
5. Allergy to any study medication.
Healthy Volunteers: False
Sex: ALL
Minimum Age: 18 Years
Maximum Age: 99 Years
Std Ages: ADULT, OLDER_ADULT
### Contacts Locations Module
#### Locations
Facility:
University of Alabama at Birmingham School of Medicine - Infectious
Disease
City: Birmingham
State: Alabama
Zip: 35233
Country: United States
##### Geo Point
Lat: 33.52066
Lon: -86.80249
#### Locations
Facility: University of California San Diego Health - Jacobs Medical Center
City: La Jolla
State: California
Zip: 29037
Country: United States
##### Geo Point
Lat: 32.84727
Lon: -117.2742
#### Locations
Facility: University of California Los Angeles Medical Center - Westwood Clinic
City: Los Angeles
State: California
Zip: 90095
Country: United States
##### Geo Point
Lat: 34.05223
Lon: -118.24368
#### Locations
Facility: University of California Irvine Medical Center - Infectious Disease
City: Orange
State: California
Zip: 92868-3298
Country: United States
##### Geo Point
Lat: 33.78779
Lon: -117.85311
#### Locations
Facility: VA Palo Alto Health Care System - Infectious Diseases
City: Palo Alto
State: California
Zip: 94304-1207
Country: United States
##### Geo Point
Lat: 37.44188
Lon: -122.14302
#### Locations
Facility:
University of California Davis Medical Center - Internal Medicine -
Infectious Disease
City: Sacramento
State: California
Zip: 95817-1460
Country: United States
##### Geo Point
Lat: 38.58157
Lon: -121.4944
#### Locations
Facility: Naval Medical Center San Diego - Infectious Disease Clinic
City: San Diego
State: California
Zip: 92314
Country: United States
##### Geo Point
Lat: 32.71533
Lon: -117.15726
#### Locations
Facility:
University of California San Francisco - Zuckerberg San Francisco
General Hospital - Division of Human Immunodeficiency Virus, Infectious
Disease, and Global Medicine
City: San Francisco
State: California
Zip: 94110-2859
Country: United States
##### Geo Point
Lat: 37.77493
Lon: -122.41942
#### Locations
Facility:
Stanford University - Stanford Hospital and Clinics - Pediatrics -
Infectious Diseases
City: Stanford
State: California
Zip: 94305-2200
Country: United States
##### Geo Point
Lat: 37.42411
Lon: -122.16608
#### Locations
Facility: Cedars Sinai Medical Center
City: West Hollywood
State: California
Zip: 90048-1804
Country: United States
##### Geo Point
Lat: 34.09001
Lon: -118.36174
#### Locations
Facility: Denver Health Division of Hospital Medicine - Main Campus
City: Denver
State: Colorado
Zip: 80204
Country: United States
##### Geo Point
Lat: 39.73915
Lon: -104.9847
#### Locations
Facility: Emory Vaccine Center - The Hope Clinic
City: Decatur
State: Georgia
Zip: 30030-1705
Country: United States
##### Geo Point
Lat: 33.77483
Lon: -84.29631
#### Locations
Facility: Northwestern Hospital - Infectious Disease
City: Chicago
State: Illinois
Zip: 60611-2908
Country: United States
##### Geo Point
Lat: 41.85003
Lon: -87.65005
#### Locations
Facility:
University of Illinois at Chicago College of Medicine - Division of
Infectious Diseases
City: Chicago
State: Illinois
Zip: 60612
Country: United States
##### Geo Point
Lat: 41.85003
Lon: -87.65005
#### Locations
Facility:
Southeast Louisiana Veterans Health Care System - Section of Infectious
Diseases
City: New Orleans
State: Louisiana
Zip: 70119
Country: United States
##### Geo Point
Lat: 29.95465
Lon: -90.07507
#### Locations
Facility:
University of Maryland School of Medicine - Center for Vaccine
Development - Baltimore
City: Baltimore
State: Maryland
Zip: 21201-1509
Country: United States
##### Geo Point
Lat: 39.29038
Lon: -76.61219
#### Locations
Facility: Johns Hopkins Hospital - Medicine - Infectious Diseases
City: Baltimore
State: Maryland
Zip: 21287-0005
Country: United States
##### Geo Point
Lat: 39.29038
Lon: -76.61219
#### Locations
Facility: Walter Reed National Military Medical Center
City: Bethesda
State: Maryland
Zip: 20889
Country: United States
##### Geo Point
Lat: 38.98067
Lon: -77.10026
#### Locations
Facility:
National Institutes of Health - Clinical Center, National Institute of
Allergy and Infectious Diseases Laboratory Of Immunoregulation, Clinical
Research Section
City: Bethesda
State: Maryland
Zip: 20892-1504
Country: United States
##### Geo Point
Lat: 38.98067
Lon: -77.10026
#### Locations
Facility: Massachusetts General Hospital - Infectious Diseases
City: Boston
State: Massachusetts
Zip: 02114-2621
Country: United States
##### Geo Point
Lat: 42.35843
Lon: -71.05977
#### Locations
Facility:
University of Massachusetts Medical School - Infectious Diseases and
Immunology
City: Worcester
State: Massachusetts
Zip: 01655-0002
Country: United States
##### Geo Point
Lat: 42.26259
Lon: -71.80229
#### Locations
Facility:
University of Minnesota Medical Center, Fairview - Infectious Diseases
and International Medicine
City: Minneapolis
State: Minnesota
Zip: 55455-0341
Country: United States
##### Geo Point
Lat: 44.97997
Lon: -93.26384
#### Locations
Facility: Saint Louis University - Center for Vaccine Development
City: Saint Louis
State: Missouri
Zip: 63104-1015
Country: United States
##### Geo Point
Lat: 38.62727
Lon: -90.19789
#### Locations
Facility: University of Nebraska Medical Center - Infectious Diseases
City: Omaha
State: Nebraska
Zip: 68105
Country: United States
##### Geo Point
Lat: 41.25626
Lon: -95.94043
#### Locations
Facility: Montefiore Medical Center - Infectious Diseases
City: Bronx
State: New York
Zip: 10467-2401
Country: United States
##### Geo Point
Lat: 40.84985
Lon: -73.86641
#### Locations
Facility:
New York University School of Medicine - Langone Medical Center -
Microbiology - Parasitology
City: New York
State: New York
Zip: 10016-6402
Country: United States
##### Geo Point
Lat: 40.71427
Lon: -74.00597
#### Locations
Facility: University of Rochester Medical Center - Vaccine Research Unit
City: Rochester
State: New York
Zip: 14642-0001
Country: United States
##### Geo Point
Lat: 43.15478
Lon: -77.61556
#### Locations
Facility: Duke Human Vaccine Institute - Duke Vaccine and Trials Unit
City: Durham
State: North Carolina
Zip: 27704
Country: United States
##### Geo Point
Lat: 35.99403
Lon: -78.89862
#### Locations
Facility:
Penn State Health Milton S. Hershey Medical Center - Division of
Infectious Diseases
City: Hershey
State: Pennsylvania
Zip: 17033
Country: United States
##### Geo Point
Lat: 40.28592
Lon: -76.65025
#### Locations
Facility: Hospital of the University of Pennsylvania - Infectious Diseases
City: Philadelphia
State: Pennsylvania
Zip: 19104-4238
Country: United States
##### Geo Point
Lat: 39.95233
Lon: -75.16379
#### Locations
Facility: Vanderbilt University Medical Center - Infectious Diseases
City: Nashville
State: Tennessee
Zip: 37232-0011
Country: United States
##### Geo Point
Lat: 36.16589
Lon: -86.78444
#### Locations
Facility: Brooke Army Medical Center
City: Fort Sam Houston
State: Texas
Zip: 78234
Country: United States
##### Geo Point
Lat: 29.45746
Lon: -98.4472
#### Locations
Facility: University of Texas Medical Branch - Division of Infectious Disease
City: Galveston
State: Texas
Zip: 77555-0435
Country: United States
##### Geo Point
Lat: 29.30135
Lon: -94.7977
#### Locations
Facility: Baylor College of Medicine - Molecular Virology and Microbiology
City: Houston
State: Texas
Zip: 77030-3411
Country: United States
##### Geo Point
Lat: 29.76328
Lon: -95.36327
#### Locations
Facility:
University of Texas Health Science Center at San Antonio - Infectious
Diseases
City: San Antonio
State: Texas
Zip: 78229-3901
Country: United States
##### Geo Point
Lat: 29.42412
Lon: -98.49363
#### Locations
Facility: University of Virginia - Acute Care Surgery
City: Charlottesville
State: Virginia
Zip: 22908-0816
Country: United States
##### Geo Point
Lat: 38.02931
Lon: -78.47668
#### Locations
Facility: Naval Medical Center Portsmouth - Infectious Disease Division
City: Portsmouth
State: Virginia
Zip: 23708
Country: United States
##### Geo Point
Lat: 36.83543
Lon: -76.29827
#### Locations
Facility: EvergreenHealth Infectious Disease Service
City: Kirkland
State: Washington
Zip: 98034
Country: United States
##### Geo Point
Lat: 47.68149
Lon: -122.20874
#### Locations
Facility: The University of Washington - Virology Research Clinic
City: Seattle
State: Washington
Zip: 98104
Country: United States
##### Geo Point
Lat: 47.60621
Lon: -122.33207
#### Locations
Facility: Providence Sacred Heart Medical Center
City: Spokane
State: Washington
Zip: 99204
Country: United States
##### Geo Point
Lat: 47.65966
Lon: -117.42908
#### Locations
Facility: Madigan Army Medical Center - Infectious Disease Clinic
City: Tacoma
State: Washington
Zip: 98431
Country: United States
##### Geo Point
Lat: 47.25288
Lon: -122.44429
#### Locations
Facility:
University of Copenhagen - Centre of Excellence for Health, Immunity and
Infections (CHIP) - Department of Infectious Diseases
City: Copenhagen
Zip: 2100
Country: Denmark
##### Geo Point
Lat: 55.67594
Lon: 12.56553
#### Locations
Facility:
Universitatsklinikum Bonn, Medizinische Klinik I - Bereich
Infektiologie/HIV der Medizinischen Klinik
City: Bonn
State: Nordrhein-Westfalen
Zip: 53127
Country: Germany
##### Geo Point
Lat: 50.73438
Lon: 7.09549
#### Locations
Facility:
Universitatsklinikum Koeln Klinik I fur Innere Medizin Klinisches
Studienzentrum fur Infektiologie I
City: Cologne
Zip: 50937
Country: Germany
##### Geo Point
Lat: 50.93333
Lon: 6.95
#### Locations
Facility: Universitätsklinikum Frankfurt -Medizinische Klinik II - Infektiologie
City: Frankfurt
Zip: 60590
Country: Germany
##### Geo Point
Lat: 50.11552
Lon: 8.68417
#### Locations
Facility: AHEPA University Hospital - 1st Department of Internal Medicine
City: Thessaloniki
State: Central Macedonia
Zip: P.O. 54636
Country: Greece
##### Geo Point
Lat: 40.64361
Lon: 22.93086
#### Locations
Facility:
Medical School of Athens University - Evangelismos Hospital - Department
of Critical Care and Pulmonary Services
City: Athens
Zip: GR-10675
Country: Greece
##### Geo Point
Lat: 37.97945
Lon: 23.71622
#### Locations
Facility:
National Center for Global Health and Medicine Hospital - Disease
Control and Prevention Center
City: Tokyo
Zip: 162-8655
Country: Japan
##### Geo Point
Lat: 35.6895
Lon: 139.69171
#### Locations
Facility:
Seoul National University Bundang Hospital - Division of Infectious
Diseases
City: Bundang-gu Seongnam-si
State: Gyeonggi-do
Zip: 13620
Country: Korea, Republic of
#### Locations
Facility: Seoul National University Hospital
City: Seoul
State: Jongno-gu
Zip: 03080
Country: Korea, Republic of
##### Geo Point
Lat: 37.566
Lon: 126.9784
#### Locations
Facility:
Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán -
Departamento de Infectologia
City: Mexico City
Zip: 14080
Country: Mexico
##### Geo Point
Lat: 19.42847
Lon: -99.12766
#### Locations
Facility:
Instituto Nacional de Enfermedades Respiratorias (INER) - Ismael Cosío
Villegas
City: Mexico City
Zip: 14080
Country: Mexico
##### Geo Point
Lat: 19.42847
Lon: -99.12766
#### Locations
Facility: National Centre for Infectious Diseases
City: Singapore
Zip: 308442
Country: Singapore
##### Geo Point
Lat: 1.28967
Lon: 103.85007
#### Locations
Facility: Hospital Clinic Barcelona, Servicio de Salud Internacional
City: Barcelona
State: Cataluña
Zip: 08036
Country: Spain
##### Geo Point
Lat: 41.38879
Lon: 2.15899
#### Locations
Facility: Hospital Germans Trias i Pujol - Servei Malalties Infeccioses
City: Barcelona
State: Cataluña
Zip: 08916
Country: Spain
##### Geo Point
Lat: 41.38879
Lon: 2.15899
#### Locations
Facility: Royal Sussex County Hospital - Department of Intensive Care Medicine
City: East Sussex
State: Brighton
Zip: BN2 5BE
Country: United Kingdom
#### Locations
Facility: Saint Thomas' Hospital - Directorate of Infection
City: London
State: London, City Of
Zip: SE1 7EH
Country: United Kingdom
##### Geo Point
Lat: 51.50853
Lon: -0.12574
#### Locations
Facility: Royal Victoria Infirmary - Department of Infectious Diseases
City: Level 6, Ward 19
State: Newcastle Upon Tyne
Zip: NE1 4LP
Country: United Kingdom
#### Locations
Facility: St. James's University Hospital - Infectious Diseases
City: Leeds
State: West Yorkshire
Zip: LS9 7TK
Country: United Kingdom
##### Geo Point
Lat: 53.79648
Lon: -1.54785
#### Locations
Facility: John Radcliffe Hospital
City: Headington, Oxford
Zip: OX3 9DU
Country: United Kingdom
### References Module
#### References
Pmid: 34473343
Type: DERIVED
Citation:
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M,
Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C,
Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N.
SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19.
Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi:
10.1002/14651858.CD013825.pub2.
#### References
Pmid: 34350582
Type: DERIVED
Citation:
Ansems K, Grundeis F, Dahms K, Mikolajewska A, Thieme V, Piechotta V,
Metzendorf MI, Stegemann M, Benstoem C, Fichtner F. Remdesivir for the
treatment of COVID-19. Cochrane Database Syst Rev. 2021 Aug
5;8(8):CD014962. doi: 10.1002/14651858.CD014962.
#### References
Pmid: 33240091
Type: DERIVED
Citation:
Sultana J, Crisafulli S, Gabbay F, Lynn E, Shakir S, Trifiro G.
Challenges for Drug Repurposing in the COVID-19 Pandemic Era. Front
Pharmacol. 2020 Nov 6;11:588654. doi: 10.3389/fphar.2020.588654.
eCollection 2020.
#### References
Pmid: 32969710
Type: DERIVED
Citation:
Maleszewski JJ, Young PM, Ackerman MJ, Halushka MK. Urgent Need for
Studies of the Late Effects of SARS-CoV-2 on the Cardiovascular System.
Circulation. 2021 Mar 30;143(13):1271-1273. doi:
10.1161/CIRCULATIONAHA.120.051362. Epub 2020 Sep 24. No abstract
available.
#### References
Pmid: 32445440
Type: DERIVED
Citation:
Beigel JH, Tomashek KM, Dodd LE, Mehta AK, Zingman BS, Kalil AC, Hohmann
E, Chu HY, Luetkemeyer A, Kline S, Lopez de Castilla D, Finberg RW,
Dierberg K, Tapson V, Hsieh L, Patterson TF, Paredes R, Sweeney DA,
Short WR, Touloumi G, Lye DC, Ohmagari N, Oh MD, Ruiz-Palacios GM,
Benfield T, Fatkenheuer G, Kortepeter MG, Atmar RL, Creech CB, Lundgren
J, Babiker AG, Pett S, Neaton JD, Burgess TH, Bonnett T, Green M,
Makowski M, Osinusi A, Nayak S, Lane HC; ACTT-1 Study Group Members.
Remdesivir for the Treatment of Covid-19 - Final Report. N Engl J Med.
2020 Nov 5;383(19):1813-1826. doi: 10.1056/NEJMoa2007764. Epub 2020 Oct
8.
## Results Section
### Participant Flow Module
Recruitment Details:
Participants were recruited at the participating sites from those
admitted with symptoms of COVID-19 confirmed by PCR. Enrollment occurred
between 21FEB2020 and 20APR2020.
#### Groups
Id: FG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
Placebo: The supplied placebo lyophilized formulation is identical in
physical appearance to the active lyophilized formulation and contains
the same inactive ingredients. Alternatively, a placebo of normal saline
of equal volume may be given if there are limitations on matching
placebo supplies.
#### Groups
Id: FG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
Remdesivir: Drug Remdesivir is a single diastereomer monophosphoramidate
prodrug designed for the intracellular delivery of a modified adenine
nucleoside analog GS-441524. In addition to the active ingredient, the
lyophilized formulation of Remdesivir contains the following inactive
ingredients: water for injection, sulfobutylether beta-cyclodextrin
sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.
#### Periods
Title: Overall Study
##### Milestones
Type: STARTED
##### Achievements
Group Id: FG000
Num Subjects: 521
##### Achievements
Group Id: FG001
Num Subjects: 541
##### Milestones
Type: Received Treatment
##### Achievements
Group Id: FG000
Num Subjects: 517
##### Achievements
Group Id: FG001
Num Subjects: 531
##### Milestones
Type: COMPLETED
##### Achievements
Group Id: FG000
Num Subjects: 508
##### Achievements
Group Id: FG001
Num Subjects: 517
##### Milestones
Type: NOT COMPLETED
##### Achievements
Group Id: FG000
Num Subjects: 13
##### Achievements
Group Id: FG001
Num Subjects: 24
##### Drop Withdraws
Type: Enrolled but not treated
##### Reasons
Group Id: FG000
Num Subjects: 4
##### Reasons
Group Id: FG001
Num Subjects: 10
##### Drop Withdraws
Type: Physician Decision
##### Reasons
Group Id: FG000
Num Subjects: 1
##### Reasons
Group Id: FG001
Num Subjects: 0
##### Drop Withdraws
Type: Withdrawal by Subject
##### Reasons
Group Id: FG000
Num Subjects: 7
##### Reasons
Group Id: FG001
Num Subjects: 9
##### Drop Withdraws
Type: Adverse Event
##### Reasons
Group Id: FG000
Num Subjects: 0
##### Reasons
Group Id: FG001
Num Subjects: 4
##### Drop Withdraws
Type: Transferred to another hospital
##### Reasons
Group Id: FG000
Num Subjects: 1
##### Reasons
Group Id: FG001
Num Subjects: 1
### Baseline Characteristics Module
#### Groups
Id: BG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
#### Groups
Id: BG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
#### Groups
Id: BG002
Title: Total
Description: Total of all reporting groups
#### Denoms
Units: Participants
##### Counts
Group Id: BG000
Value: 521
##### Counts
Group Id: BG001
Value: 541
##### Counts
Group Id: BG002
Value: 1062
#### Measures
Title: Age, Categorical
Param Type: COUNT_OF_PARTICIPANTS
Unit Of Measure: Participants
##### Classes
##### Categories
Title: <=18 years
##### Measurements
Group Id: BG000
Value: 0
##### Measurements
Group Id: BG001
Value: 0
##### Measurements
Group Id: BG002
Value: 0
##### Categories
Title: Between 18 and 65 years
##### Measurements
Group Id: BG000
Value: 324
##### Measurements
Group Id: BG001
Value: 354
##### Measurements
Group Id: BG002
Value: 678
##### Categories
Title: >=65 years
##### Measurements
Group Id: BG000
Value: 197
##### Measurements
Group Id: BG001
Value: 187
##### Measurements
Group Id: BG002
Value: 384
#### Measures
Title: Age, Continuous
Param Type: MEAN
Dispersion Type: STANDARD_DEVIATION
Unit Of Measure: years
##### Classes
##### Categories
##### Measurements
Group Id: BG000
Value: 59.2
Spread: 15.4
##### Measurements
Group Id: BG001
Value: 58.6
Spread: 14.6
##### Measurements
Group Id: BG002
Value: 58.9
Spread: 15.0
#### Measures
Title: Sex: Female, Male
Param Type: COUNT_OF_PARTICIPANTS
Unit Of Measure: Participants
##### Classes
##### Categories
Title: Female
##### Measurements
Group Id: BG000
Value: 189
##### Measurements
Group Id: BG001
Value: 189
##### Measurements
Group Id: BG002
Value: 378
##### Categories
Title: Male
##### Measurements
Group Id: BG000
Value: 332
##### Measurements
Group Id: BG001
Value: 352
##### Measurements
Group Id: BG002
Value: 684
#### Measures
Title: Ethnicity (NIH/OMB)
Param Type: COUNT_OF_PARTICIPANTS
Unit Of Measure: Participants
##### Classes
##### Categories
Title: Hispanic or Latino
##### Measurements
Group Id: BG000
Value: 116
##### Measurements
Group Id: BG001
Value: 134
##### Measurements
Group Id: BG002
Value: 250
##### Categories
Title: Not Hispanic or Latino
##### Measurements
Group Id: BG000
Value: 373
##### Measurements
Group Id: BG001
Value: 382
##### Measurements
Group Id: BG002
Value: 755
##### Categories
Title: Unknown or Not Reported
##### Measurements
Group Id: BG000
Value: 32
##### Measurements
Group Id: BG001
Value: 25
##### Measurements
Group Id: BG002
Value: 57
#### Measures
Title: Race (NIH/OMB)
Param Type: COUNT_OF_PARTICIPANTS
Unit Of Measure: Participants
##### Classes
##### Categories
Title: American Indian or Alaska Native
##### Measurements
Group Id: BG000
Value: 3
##### Measurements
Group Id: BG001
Value: 4
##### Measurements
Group Id: BG002
Value: 7
##### Categories
Title: Asian
##### Measurements
Group Id: BG000
Value: 56
##### Measurements
Group Id: BG001
Value: 79
##### Measurements
Group Id: BG002
Value: 135
##### Categories
Title: Native Hawaiian or Other Pacific Islander
##### Measurements
Group Id: BG000
Value: 2
##### Measurements
Group Id: BG001
Value: 2
##### Measurements
Group Id: BG002
Value: 4
##### Categories
Title: Black or African American
##### Measurements
Group Id: BG000
Value: 117
##### Measurements
Group Id: BG001
Value: 109
##### Measurements
Group Id: BG002
Value: 226
##### Categories
Title: White
##### Measurements
Group Id: BG000
Value: 287
##### Measurements
Group Id: BG001
Value: 279
##### Measurements
Group Id: BG002
Value: 566
##### Categories
Title: More than one race
##### Measurements
Group Id: BG000
Value: 1
##### Measurements
Group Id: BG001
Value: 2
##### Measurements
Group Id: BG002
Value: 3
##### Categories
Title: Unknown or Not Reported
##### Measurements
Group Id: BG000
Value: 55
##### Measurements
Group Id: BG001
Value: 66
##### Measurements
Group Id: BG002
Value: 121
#### Measures
Title: Region of Enrollment
Param Type: NUMBER
Unit Of Measure: participants
##### Classes
Title: Greece
##### Categories
##### Measurements
Group Id: BG000
Value: 19
##### Measurements
Group Id: BG001
Value: 14
##### Measurements
Group Id: BG002
Value: 33
##### Classes
Title: South Korea
##### Categories
##### Measurements
Group Id: BG000
Value: 12
##### Measurements
Group Id: BG001
Value: 9
##### Measurements
Group Id: BG002
Value: 21
##### Classes
Title: Singapore
##### Categories
##### Measurements
Group Id: BG000
Value: 7
##### Measurements
Group Id: BG001
Value: 9
##### Measurements
Group Id: BG002
Value: 16
##### Classes
Title: United States
##### Categories
##### Measurements
Group Id: BG000
Value: 410
##### Measurements
Group Id: BG001
Value: 427
##### Measurements
Group Id: BG002
Value: 837
##### Classes
Title: Japan
##### Categories
##### Measurements
Group Id: BG000
Value: 7
##### Measurements
Group Id: BG001
Value: 8
##### Measurements
Group Id: BG002
Value: 15
##### Classes
Title: Denmark
##### Categories
##### Measurements
Group Id: BG000
Value: 21
##### Measurements
Group Id: BG001
Value: 22
##### Measurements
Group Id: BG002
Value: 43
##### Classes
Title: Mexico
##### Categories
##### Measurements
Group Id: BG000
Value: 6
##### Measurements
Group Id: BG001
Value: 4
##### Measurements
Group Id: BG002
Value: 10
##### Classes
Title: United Kingdom
##### Categories
##### Measurements
Group Id: BG000
Value: 21
##### Measurements
Group Id: BG001
Value: 25
##### Measurements
Group Id: BG002
Value: 46
##### Classes
Title: Germany
##### Categories
##### Measurements
Group Id: BG000
Value: 6
##### Measurements
Group Id: BG001
Value: 7
##### Measurements
Group Id: BG002
Value: 13
##### Classes
Title: Spain
##### Categories
##### Measurements
Group Id: BG000
Value: 12
##### Measurements
Group Id: BG001
Value: 16
##### Measurements
Group Id: BG002
Value: 28
#### Measures
Title: Disease severity
Description:
Mild-moderate disease: SpO2 \> 94% and respiratory rate \< 24
breaths/min without supplemental oxygen.
Severe disease: requiring mechanical ventilation, requiring oxygen, a
SpO2 = 94% on room air, or tachypnea (respiratory rate = 24
breaths/min).
Param Type: COUNT_OF_PARTICIPANTS
Unit Of Measure: Participants
##### Classes
Title: Mild-to-moderate disease severity
##### Categories
##### Measurements
Group Id: BG000
Value: 50
##### Measurements
Group Id: BG001
Value: 55
##### Measurements
Group Id: BG002
Value: 105
##### Classes
Title: Severe disease severity
##### Categories
##### Measurements
Group Id: BG000
Value: 471
##### Measurements
Group Id: BG001
Value: 486
##### Measurements
Group Id: BG002
Value: 957
### Outcome Measures Module
#### Outcome Measures
Type: PRIMARY
Title: Time to Recovery
Description:
Day of recovery is defined as the first day on which the subject
satisfies one of the following three categories from the ordinal scale:
1) Hospitalized, not requiring supplemental oxygen - no longer requires
ongoing medical care; 2) Not hospitalized, limitation on activities
and/or requiring home oxygen; 3) Not hospitalized, no limitations on
activities.
Population Description:
The intent-to-treat (ITT) population includes all participants who were
randomized
Reporting Status: POSTED
Param Type: MEDIAN
Dispersion Type: 95% Confidence Interval
Unit Of Measure: Days
Time Frame: Day 1 through Day 29
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 521
##### Counts
Group Id: OG001
Value: 541
##### Classes
##### Categories
##### Measurements
Group Id: OG000
Value: 15
Lower Limit: 13
Upper Limit: 18
##### Measurements
Group Id: OG001
Value: 10
Lower Limit: 9
Upper Limit: 11
##### Analyses
Non Inferiority Type: SUPERIORITY
P Value: <0.001
Statistical Method: Log Rank
Param Type: Cox Proportional Hazard
Param Value: 1.29
Ci Pct Value: 95
Ci Num Sides: TWO_SIDED
Ci Lower Limit: 1.12
Ci Upper Limit: 1.49
Group Ids: OG000, OG001
#### Outcome Measures
Type: SECONDARY
Title: Change From Baseline in Alanine Transaminase (ALT)
Description:
Blood to evaluate ALT was collected at Days 1, 3, 5, 8, and 11 while
participants were inpatient, and at Days 15 and 29, with the Day 1
assessment serving as baseline. Participants who had been discharged had
blood collected if infection control measures allowed for in-person
visits after discharge.
Population Description:
The safety population includes all treated participants with available
data at baseline and the post baseline assessment point, analyzed as
treated.
Reporting Status: POSTED
Param Type: MEAN
Dispersion Type: Standard Deviation
Unit Of Measure: Units/Liter (U/L)
Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 463
##### Counts
Group Id: OG001
Value: 465
##### Classes
Title: Day 3
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 463
##### Counts
Group Id: OG001
Value: 465
##### Categories
##### Measurements
Group Id: OG000
Value: 14.3
Spread: 88
##### Measurements
Group Id: OG001
Value: 2.9
Spread: 31.5
##### Classes
Title: Day 5
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 403
##### Counts
Group Id: OG001
Value: 398
##### Categories
##### Measurements
Group Id: OG000
Value: 23.1
Spread: 70.6
##### Measurements
Group Id: OG001
Value: 10.8
Spread: 55.8
##### Classes
Title: Day 8
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 327
##### Counts
Group Id: OG001
Value: 296
##### Categories
##### Measurements
Group Id: OG000
Value: 24.2
Spread: 79.7
##### Measurements
Group Id: OG001
Value: 8.9
Spread: 54.2
##### Classes
Title: Day 11
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 257
##### Counts
Group Id: OG001
Value: 227
##### Categories
##### Measurements
Group Id: OG000
Value: 27.7
Spread: 89.8
##### Measurements
Group Id: OG001
Value: 3.4
Spread: 48.4
##### Classes
Title: Day 15
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 242
##### Counts
Group Id: OG001
Value: 257
##### Categories
##### Measurements
Group Id: OG000
Value: 28.1
Spread: 110.1
##### Measurements
Group Id: OG001
Value: 1.7
Spread: 47.4
##### Classes
Title: Day 29
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 180
##### Counts
Group Id: OG001
Value: 220
##### Categories
##### Measurements
Group Id: OG000
Value: -3.9
Spread: 62.2
##### Measurements
Group Id: OG001
Value: -6.8
Spread: 43.7
#### Outcome Measures
Type: SECONDARY
Title: Change From Baseline in Aspartate Transaminase (AST)
Description:
Blood to evaluate AST was collected at Days 1, 3, 5, 8, and 11 while
participants were inpatient, and at Days 15 and 29, with the Day 1
assessment serving as baseline. Participants who had been discharged had
blood collected if infection control measures allowed for in-person
visits after discharge.
Population Description:
The safety population includes all treated participants with available
data at baseline and the post baseline assessment point, analyzed as
treated.
Reporting Status: POSTED
Param Type: MEAN
Dispersion Type: Standard Deviation
Unit Of Measure: Units/Liter (U/L)
Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 438
##### Counts
Group Id: OG001
Value: 445
##### Classes
Title: Day 3
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 438
##### Counts
Group Id: OG001
Value: 445
##### Categories
##### Measurements
Group Id: OG000
Value: 13.7
Spread: 90.7
##### Measurements
Group Id: OG001
Value: -2.0
Spread: 29.1
##### Classes
Title: Day 5
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 384
##### Counts
Group Id: OG001
Value: 380
##### Categories
##### Measurements
Group Id: OG000
Value: 12.8
Spread: 66.2
##### Measurements
Group Id: OG001
Value: 6.0
Spread: 58.9
##### Classes
Title: Day 8
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 315
##### Counts
Group Id: OG001
Value: 285
##### Categories
##### Measurements
Group Id: OG000
Value: 13.1
Spread: 114.6
##### Measurements
Group Id: OG001
Value: 1.1
Spread: 55.9
##### Classes
Title: Day 11
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 247
##### Counts
Group Id: OG001
Value: 219
##### Categories
##### Measurements
Group Id: OG000
Value: 11.5
Spread: 78.8
##### Measurements
Group Id: OG001
Value: -0.3
Spread: 51.7
##### Classes
Title: Day 15
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 236
##### Counts
Group Id: OG001
Value: 248
##### Categories
##### Measurements
Group Id: OG000
Value: 4.2
Spread: 73.0
##### Measurements
Group Id: OG001
Value: -2.3
Spread: 60.4
##### Classes
Title: Day 29
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 170
##### Counts
Group Id: OG001
Value: 208
##### Categories
##### Measurements
Group Id: OG000
Value: -18.4
Spread: 47.2
##### Measurements
Group Id: OG001
Value: -14.0
Spread: 52.2
#### Outcome Measures
Type: SECONDARY
Title: Change From Baseline in Creatinine
Description:
Blood to evaluate serum creatinine was collected at Days 1, 3, 5, 8, and
11 while participants were inpatient, and at Days 15 and 29, with the
Day 1 assessment serving as baseline. Participants who had been
discharged had blood collected if infection control measures allowed for
in-person visits after discharge.
Population Description:
The safety population includes all treated participants with available
data at baseline and the post baseline assessment point, analyzed as
treated.
Reporting Status: POSTED
Param Type: MEAN
Dispersion Type: Standard Deviation
Unit Of Measure: milligrams/deciliter (mg/dL)
Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 475
##### Counts
Group Id: OG001
Value: 482
##### Classes
Title: Day 3
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 475
##### Counts
Group Id: OG001
Value: 482
##### Categories
##### Measurements
Group Id: OG000
Value: 0.037
Spread: 0.517
##### Measurements
Group Id: OG001
Value: 0.038
Spread: 0.569
##### Classes
Title: Day 5
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 418
##### Counts
Group Id: OG001
Value: 411
##### Categories
##### Measurements
Group Id: OG000
Value: -0.695
Spread: 17.552
##### Measurements
Group Id: OG001
Value: 0.075
Spread: 0.762
##### Classes
Title: Day 8
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 335
##### Counts
Group Id: OG001
Value: 309
##### Categories
##### Measurements
Group Id: OG000
Value: -0.882
Spread: 19.637
##### Measurements
Group Id: OG001
Value: 0.158
Spread: 0.951
##### Classes
Title: Day 11
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 269
##### Counts
Group Id: OG001
Value: 234
##### Categories
##### Measurements
Group Id: OG000
Value: 1.173
Spread: 15.440
##### Measurements
Group Id: OG001
Value: 0.236
Spread: 1.057
##### Classes
Title: Day 15
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 249
##### Counts
Group Id: OG001
Value: 262
##### Categories
##### Measurements
Group Id: OG000
Value: -1.239
Spread: 22.755
##### Measurements
Group Id: OG001
Value: 0.319
Spread: 2.147
##### Classes
Title: Day 29
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 189
##### Counts
Group Id: OG001
Value: 229
##### Categories
##### Measurements
Group Id: OG000
Value: -1.863
Spread: 26.093
##### Measurements
Group Id: OG001
Value: 0.075
Spread: 0.644
#### Outcome Measures
Type: SECONDARY
Title: Change From Baseline in Glucose
Description:
Blood to evaluate serum glucose was collected at Days 1, 3, 5, 8, and 11
while participants were inpatient, and at Days 15 and 29, with the Day 1
assessment serving as baseline. Participants who had been discharged had
blood collected if infection control measures allowed for in-person
visits after discharge.
Population Description:
The safety population includes all treated participants with available
data at baseline and the post baseline assessment point, analyzed as
treated.
Reporting Status: POSTED
Param Type: MEAN
Dispersion Type: Standard Deviation
Unit Of Measure: mg/dL
Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 456
##### Counts
Group Id: OG001
Value: 459
##### Classes
Title: Day 3
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 456
##### Counts
Group Id: OG001
Value: 459
##### Categories
##### Measurements
Group Id: OG000
Value: -0.2
Spread: 53.4
##### Measurements
Group Id: OG001
Value: -3.0
Spread: 49.4
##### Classes
Title: Day 5
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 407
##### Counts
Group Id: OG001
Value: 395
##### Categories
##### Measurements
Group Id: OG000
Value: 6.3
Spread: 60.2
##### Measurements
Group Id: OG001
Value: 2.1
Spread: 63.8
##### Classes
Title: Day 8
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 323
##### Counts
Group Id: OG001
Value: 301
##### Categories
##### Measurements
Group Id: OG000
Value: 2.2
Spread: 73.3
##### Measurements
Group Id: OG001
Value: 3.2
Spread: 68.0
##### Classes
Title: Day 11
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 260
##### Counts
Group Id: OG001
Value: 228
##### Categories
##### Measurements
Group Id: OG000
Value: 1.0
Spread: 70.1
##### Measurements
Group Id: OG001
Value: -0.1
Spread: 77.4
##### Classes
Title: Day 15
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 241
##### Counts
Group Id: OG001
Value: 250
##### Categories
##### Measurements
Group Id: OG000
Value: -2.8
Spread: 64.4
##### Measurements
Group Id: OG001
Value: -2.9
Spread: 75.4
##### Classes
Title: Day 29
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 180
##### Counts
Group Id: OG001
Value: 219
##### Categories
##### Measurements
Group Id: OG000
Value: -13.5
Spread: 96.8
##### Measurements
Group Id: OG001
Value: -11.7
Spread: 75.4
#### Outcome Measures
Type: SECONDARY
Title: Change From Baseline in Hemoglobin
Description:
Blood to evaluate hemoglobin was collected at Days 1, 3, 5, 8, and 11
while participants were inpatient, and at Days 15 and 29, with the Day 1
assessment serving as baseline. Participants who had been discharged had
blood collected if infection control measures allowed for in-person
visits after discharge.
Population Description:
The safety population includes all treated participants with available
data at baseline and the post baseline assessment point, analyzed as
treated.
Reporting Status: POSTED
Param Type: MEAN
Dispersion Type: Standard Deviation
Unit Of Measure: grams/deciliter (g/dL)
Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 475
##### Counts
Group Id: OG001
Value: 475
##### Classes
Title: Day 3
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 475
##### Counts
Group Id: OG001
Value: 475
##### Categories
##### Measurements
Group Id: OG000
Value: -0.52
Spread: 1.10
##### Measurements
Group Id: OG001
Value: -0.69
Spread: 5.36
##### Classes
Title: Day 5
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 420
##### Counts
Group Id: OG001
Value: 406
##### Categories
##### Measurements
Group Id: OG000
Value: -0.83
Spread: 1.22
##### Measurements
Group Id: OG001
Value: -0.99
Spread: 5.83
##### Classes
Title: Day 8
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 334
##### Counts
Group Id: OG001
Value: 310
##### Categories
##### Measurements
Group Id: OG000
Value: -1.22
Spread: 1.42
##### Measurements
Group Id: OG001
Value: -0.49
Spread: 6.54
##### Classes
Title: Day 11
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 269
##### Counts
Group Id: OG001
Value: 230
##### Categories
##### Measurements
Group Id: OG000
Value: -1.66
Spread: 1.67
##### Measurements
Group Id: OG001
Value: -1.29
Spread: 1.93
##### Classes
Title: Day 15
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 253
##### Counts
Group Id: OG001
Value: 260
##### Categories
##### Measurements
Group Id: OG000
Value: -1.51
Spread: 2.02
##### Measurements
Group Id: OG001
Value: -1.02
Spread: 3.04
##### Classes
Title: Day 29
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 189
##### Counts
Group Id: OG001
Value: 227
##### Categories
##### Measurements
Group Id: OG000
Value: -1.02
Spread: 2.38
##### Measurements
Group Id: OG001
Value: -1.21
Spread: 7.91
#### Outcome Measures
Type: SECONDARY
Title: Change From Baseline in Platelets
Description:
Blood to evaluate platelets was collected at Days 1, 3, 5, 8, and 11
while participants were inpatient, and at Days 15 and 29, with the Day 1
assessment serving as baseline. Participants who had been discharged had
blood collected if infection control measures allowed for in-person
visits after discharge.
Population Description:
The safety population includes all treated participants with available
data at baseline and the post baseline assessment point, analyzed as
treated.
Reporting Status: POSTED
Param Type: MEAN
Dispersion Type: Standard Deviation
Unit Of Measure: 10^9 cells/liter
Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 471
##### Counts
Group Id: OG001
Value: 474
##### Classes
Title: Day 3
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 471
##### Counts
Group Id: OG001
Value: 474
##### Categories
##### Measurements
Group Id: OG000
Value: 39.3
Spread: 60.0
##### Measurements
Group Id: OG001
Value: 46.0
Spread: 62.6
##### Classes
Title: Day 5
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 419
##### Counts
Group Id: OG001
Value: 403
##### Categories
##### Measurements
Group Id: OG000
Value: 76.5
Spread: 100.5
##### Measurements
Group Id: OG001
Value: 90.1
Spread: 99.9
##### Classes
Title: Day 8
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 332
##### Counts
Group Id: OG001
Value: 308
##### Categories
##### Measurements
Group Id: OG000
Value: 111.8
Spread: 137.4
##### Measurements
Group Id: OG001
Value: 130.8
Spread: 128.1
##### Classes
Title: Day 11
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 269
##### Counts
Group Id: OG001
Value: 229
##### Categories
##### Measurements
Group Id: OG000
Value: 109.3
Spread: 149.3
##### Measurements
Group Id: OG001
Value: 101.0
Spread: 145.0
##### Classes
Title: Day 15
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 252
##### Counts
Group Id: OG001
Value: 258
##### Categories
##### Measurements
Group Id: OG000
Value: 96.5
Spread: 154.2
##### Measurements
Group Id: OG001
Value: 71.1
Spread: 133.3
##### Classes
Title: Day 29
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 189
##### Counts
Group Id: OG001
Value: 224
##### Categories
##### Measurements
Group Id: OG000
Value: 32.7
Spread: 124.2
##### Measurements
Group Id: OG001
Value: 39.6
Spread: 107.4
#### Outcome Measures
Type: SECONDARY
Title: Change From Baseline in Prothrombin Time (PT)
Description:
Blood to evaluate PT was collected at Days 1, 3, 5, 8, and 11 while
participants were inpatient, and at Days 15 and 29, with the Day 1
assessment serving as baseline. Participants who had been discharged had
blood collected if infection control measures allowed for in-person
visits after discharge.
Population Description:
The safety population includes all treated participants with available
data at baseline and the post baseline assessment point, analyzed as
treated.
Reporting Status: POSTED
Param Type: MEAN
Dispersion Type: Standard Deviation
Unit Of Measure: seconds
Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 339
##### Counts
Group Id: OG001
Value: 352
##### Classes
Title: Day 3
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 339
##### Counts
Group Id: OG001
Value: 352
##### Categories
##### Measurements
Group Id: OG000
Value: -0.18
Spread: 4.28
##### Measurements
Group Id: OG001
Value: 0.44
Spread: 5.22
##### Classes
Title: Day 5
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 296
##### Counts
Group Id: OG001
Value: 306
##### Categories
##### Measurements
Group Id: OG000
Value: -0.30
Spread: 4.72
##### Measurements
Group Id: OG001
Value: 1.15
Spread: 5.72
##### Classes
Title: Day 8
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 246
##### Counts
Group Id: OG001
Value: 234
##### Categories
##### Measurements
Group Id: OG000
Value: 0.01
Spread: 2.59
##### Measurements
Group Id: OG001
Value: 1.43
Spread: 3.89
##### Classes
Title: Day 11
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 199
##### Counts
Group Id: OG001
Value: 182
##### Categories
##### Measurements
Group Id: OG000
Value: 0.86
Spread: 7.85
##### Measurements
Group Id: OG001
Value: 1.88
Spread: 5.68
##### Classes
Title: Day 15
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 176
##### Counts
Group Id: OG001
Value: 193
##### Categories
##### Measurements
Group Id: OG000
Value: 0.34
Spread: 4.33
##### Measurements
Group Id: OG001
Value: -0.03
Spread: 4.25
##### Classes
Title: Day 29
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 134
##### Counts
Group Id: OG001
Value: 163
##### Categories
##### Measurements
Group Id: OG000
Value: -0.28
Spread: 3.20
##### Measurements
Group Id: OG001
Value: -0.63
Spread: 3.37
#### Outcome Measures
Type: SECONDARY
Title: Change From Baseline in Total Bilirubin
Description:
Blood to evaluate total bilirubin was collected at Days 1, 3, 5, 8, and
11 while participants were inpatient, and at Days 15 and 29, with the
Day 1 assessment serving as baseline. Participants who had been
discharged had blood collected if infection control measures allowed for
in-person visits after discharge.
Population Description:
The safety population includes all treated participants with available
data at baseline and the post baseline assessment point, analyzed as
treated.
Reporting Status: POSTED
Param Type: MEAN
Dispersion Type: Standard Deviation
Unit Of Measure: mg/dL
Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 451
##### Counts
Group Id: OG001
Value: 456
##### Classes
Title: Day 3
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 451
##### Counts
Group Id: OG001
Value: 456
##### Categories
##### Measurements
Group Id: OG000
Value: 0.08
Spread: 1.25
##### Measurements
Group Id: OG001
Value: -0.04
Spread: 0.75
##### Classes
Title: Day 5
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 394
##### Counts
Group Id: OG001
Value: 389
##### Categories
##### Measurements
Group Id: OG000
Value: 0.58
Spread: 4.13
##### Measurements
Group Id: OG001
Value: -0.03
Spread: 1.03
##### Classes
Title: Day 8
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 315
##### Counts
Group Id: OG001
Value: 288
##### Categories
##### Measurements
Group Id: OG000
Value: 0.22
Spread: 2.56
##### Measurements
Group Id: OG001
Value: 0.01
Spread: 1.38
##### Classes
Title: Day 11
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 247
##### Counts
Group Id: OG001
Value: 220
##### Categories
##### Measurements
Group Id: OG000
Value: 0.23
Spread: 2.79
##### Measurements
Group Id: OG001
Value: 0.07
Spread: 1.48
##### Classes
Title: Day 15
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 237
##### Counts
Group Id: OG001
Value: 254
##### Categories
##### Measurements
Group Id: OG000
Value: 0.00
Spread: 1.80
##### Measurements
Group Id: OG001
Value: 0.09
Spread: 1.54
##### Classes
Title: Day 29
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 178
##### Counts
Group Id: OG001
Value: 216
##### Categories
##### Measurements
Group Id: OG000
Value: -0.17
Spread: 1.65
##### Measurements
Group Id: OG001
Value: -0.12
Spread: 1.77
#### Outcome Measures
Type: SECONDARY
Title: Change From Baseline in White Blood Cell Count (WBC)
Description:
Blood to evaluate WBC was collected at Days 1, 3, 5, 8, and 11 while
participants were inpatient, and at Days 15 and 29, with the Day 1
assessment serving as baseline. Participants who had been discharged had
blood collected if infection control measures allowed for in-person
visits after discharge.
Population Description:
The safety population includes all treated participants with available
data at baseline and the post baseline assessment point, analyzed as
treated.
Reporting Status: POSTED
Param Type: MEAN
Dispersion Type: Standard Deviation
Unit Of Measure: 10^9 cells/liter
Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 474
##### Counts
Group Id: OG001
Value: 475
##### Classes
Title: Day 3
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 474
##### Counts
Group Id: OG001
Value: 475
##### Categories
##### Measurements
Group Id: OG000
Value: 18.691
Spread: 424.837
##### Measurements
Group Id: OG001
Value: -18.970
Spread: 301.944
##### Classes
Title: Day 5
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 419
##### Counts
Group Id: OG001
Value: 405
##### Categories
##### Measurements
Group Id: OG000
Value: 9.886
Spread: 566.175
##### Measurements
Group Id: OG001
Value: -28.209
Spread: 412.615
##### Classes
Title: Day 8
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 333
##### Counts
Group Id: OG001
Value: 310
##### Categories
##### Measurements
Group Id: OG000
Value: 27.223
Spread: 479.095
##### Measurements
Group Id: OG001
Value: -45.997
Spread: 602.461
##### Classes
Title: Day 11
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 268
##### Counts
Group Id: OG001
Value: 230
##### Categories
##### Measurements
Group Id: OG000
Value: 1.967
Spread: 16.042
##### Measurements
Group Id: OG001
Value: -34.702
Spread: 574.065
##### Classes
Title: Day 15
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 252
##### Counts
Group Id: OG001
Value: 260
##### Categories
##### Measurements
Group Id: OG000
Value: 56.311
Spread: 620.551
##### Measurements
Group Id: OG001
Value: -70.884
Spread: 600.011
##### Classes
Title: Day 29
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 189
##### Counts
Group Id: OG001
Value: 226
##### Categories
##### Measurements
Group Id: OG000
Value: -0.898
Spread: 17.801
##### Measurements
Group Id: OG001
Value: 0.251
Spread: 3.987
#### Outcome Measures
Type: SECONDARY
Title: Change From Baseline in Neutrophils
Description:
Blood to evaluate neutrophils was collected at Days 1, 3, 5, 8, and 11
while participants were inpatient, and at Days 15 and 29, with the Day 1
assessment serving as baseline. Participants who had been discharged had
blood collected if infection control measures allowed for in-person
visits after discharge.
Population Description:
The safety population includes all treated participants with available
data at baseline and the post baseline assessment point, analyzed as
treated.
Reporting Status: POSTED
Param Type: MEAN
Dispersion Type: Standard Deviation
Unit Of Measure: 10^9 cells/liter
Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 463
##### Counts
Group Id: OG001
Value: 459
##### Classes
Title: Day 3
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 463
##### Counts
Group Id: OG001
Value: 459
##### Categories
##### Measurements
Group Id: OG000
Value: 9.429
Spread: 260.345
##### Measurements
Group Id: OG001
Value: -8.093
Spread: 135.068
##### Classes
Title: Day 5
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 406
##### Counts
Group Id: OG001
Value: 389
##### Categories
##### Measurements
Group Id: OG000
Value: 4.177
Spread: 362.782
##### Measurements
Group Id: OG001
Value: -15.067
Spread: 216.532
##### Classes
Title: Day 8
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 317
##### Counts
Group Id: OG001
Value: 298
##### Categories
##### Measurements
Group Id: OG000
Value: 17.916
Spread: 305.321
##### Measurements
Group Id: OG001
Value: -28.179
Spread: 365.099
##### Classes
Title: Day 11
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 257
##### Counts
Group Id: OG001
Value: 220
##### Categories
##### Measurements
Group Id: OG000
Value: 3.010
Spread: 27.502
##### Measurements
Group Id: OG001
Value: -21.773
Spread: 354.025
##### Classes
Title: Day 15
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 241
##### Counts
Group Id: OG001
Value: 253
##### Categories
##### Measurements
Group Id: OG000
Value: 36.024
Spread: 389.093
##### Measurements
Group Id: OG001
Value: -39.988
Spread: 333.088
##### Classes
Title: Day 29
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 177
##### Counts
Group Id: OG001
Value: 218
##### Categories
##### Measurements
Group Id: OG000
Value: -1.269
Spread: 7.160
##### Measurements
Group Id: OG001
Value: -0.840
Spread: 3.666
#### Outcome Measures
Type: SECONDARY
Title: Change From Baseline in Lymphocytes
Description:
Blood to evaluate lymphocytes was collected at Days 1, 3, 5, 8, and 11
while participants were inpatient, and at Days 15 and 29, with the Day 1
assessment serving as baseline. Participants who had been discharged had
blood collected if infection control measures allowed for in-person
visits after discharge.
Population Description:
The safety population includes all treated participants with available
data at baseline and the post baseline assessment point, analyzed as
treated.
Reporting Status: POSTED
Param Type: MEAN
Dispersion Type: Standard Deviation
Unit Of Measure: 10^9 cells/liter
Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 463
##### Counts
Group Id: OG001
Value: 459
##### Classes
Title: Day 3
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 463
##### Counts
Group Id: OG001
Value: 459
##### Categories
##### Measurements
Group Id: OG000
Value: 5.883
Spread: 118.740
##### Measurements
Group Id: OG001
Value: -7.847
Spread: 131.548
##### Classes
Title: Day 5
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 406
##### Counts
Group Id: OG001
Value: 389
##### Categories
##### Measurements
Group Id: OG000
Value: 4.064
Spread: 141.580
##### Measurements
Group Id: OG001
Value: -11.723
Spread: 167.428
##### Classes
Title: Day 8
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 317
##### Counts
Group Id: OG001
Value: 299
##### Categories
##### Measurements
Group Id: OG000
Value: 8.006
Spread: 137.149
##### Measurements
Group Id: OG001
Value: -15.455
Spread: 194.111
##### Classes
Title: Day 11
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 257
##### Counts
Group Id: OG001
Value: 220
##### Categories
##### Measurements
Group Id: OG000
Value: 0.393
Spread: 1.371
##### Measurements
Group Id: OG001
Value: -12.016
Spread: 183.060
##### Classes
Title: Day 15
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 241
##### Counts
Group Id: OG001
Value: 253
##### Categories
##### Measurements
Group Id: OG000
Value: 14.793
Spread: 159.583
##### Measurements
Group Id: OG001
Value: -23.836
Spread: 218.653
##### Classes
Title: Day 29
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 177
##### Counts
Group Id: OG001
Value: 218
##### Categories
##### Measurements
Group Id: OG000
Value: 0.668
Spread: 1.406
##### Measurements
Group Id: OG001
Value: 0.743
Spread: 0.664
#### Outcome Measures
Type: SECONDARY
Title: Change From Baseline in Monocytes
Description:
Blood to evaluate monocytes was collected at Days 1, 3, 5, 8, and 11
while participants were inpatient, and at Days 15 and 29, with the Day 1
assessment serving as baseline. Participants who had been discharged had
blood collected if infection control measures allowed for in-person
visits after discharge.
Population Description:
The safety population includes all treated participants with available
data at baseline and the post baseline assessment point, analyzed as
treated.
Reporting Status: POSTED
Param Type: MEAN
Dispersion Type: Standard Deviation
Unit Of Measure: 10^9 cells/liter
Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 463
##### Counts
Group Id: OG001
Value: 458
##### Classes
Title: Day 3
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 463
##### Counts
Group Id: OG001
Value: 458
##### Categories
##### Measurements
Group Id: OG000
Value: 2.448
Spread: 41.304
##### Measurements
Group Id: OG001
Value: -2.940
Spread: 46.752
##### Classes
Title: Day 5
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 406
##### Counts
Group Id: OG001
Value: 388
##### Categories
##### Measurements
Group Id: OG000
Value: 1.498
Spread: 57.686
##### Measurements
Group Id: OG001
Value: -2.628
Spread: 39.329
##### Classes
Title: Day 8
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 316
##### Counts
Group Id: OG001
Value: 299
##### Categories
##### Measurements
Group Id: OG000
Value: 2.324
Spread: 36.626
##### Measurements
Group Id: OG001
Value: -3.645
Spread: 48.636
##### Classes
Title: Day 11
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 257
##### Counts
Group Id: OG001
Value: 220
##### Categories
##### Measurements
Group Id: OG000
Value: 0.383
Spread: 0.744
##### Measurements
Group Id: OG001
Value: -2.539
Spread: 43.454
##### Classes
Title: Day 15
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 241
##### Counts
Group Id: OG001
Value: 253
##### Categories
##### Measurements
Group Id: OG000
Value: 6.475
Spread: 69.019
##### Measurements
Group Id: OG001
Value: -8.738
Spread: 74.365
##### Classes
Title: Day 29
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 177
##### Counts
Group Id: OG001
Value: 218
##### Categories
##### Measurements
Group Id: OG000
Value: 0.125
Spread: 0.485
##### Measurements
Group Id: OG001
Value: 0.117
Spread: 0.340
#### Outcome Measures
Type: SECONDARY
Title: Change From Baseline in Basophils
Description:
Blood to evaluate basophils was collected at Days 1, 3, 5, 8, and 11
while participants were inpatient, and at Days 15 and 29, with the Day 1
assessment serving as baseline. Participants who had been discharged had
blood collected if infection control measures allowed for in-person
visits after discharge.
Population Description:
The safety population includes all treated participants with available
data at baseline and the post baseline assessment point, analyzed as
treated.
Reporting Status: POSTED
Param Type: MEAN
Dispersion Type: Standard Deviation
Unit Of Measure: 10^9 cells/liter
Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 455
##### Counts
Group Id: OG001
Value: 452
##### Classes
Title: Day 3
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 455
##### Counts
Group Id: OG001
Value: 452
##### Categories
##### Measurements
Group Id: OG000
Value: 0.020
Spread: 0.257
##### Measurements
Group Id: OG001
Value: 0.005
Spread: 0.043
##### Classes
Title: Day 5
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 394
##### Counts
Group Id: OG001
Value: 380
##### Categories
##### Measurements
Group Id: OG000
Value: 0.038
Spread: 0.501
##### Measurements
Group Id: OG001
Value: 0.005
Spread: 0.370
##### Classes
Title: Day 8
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 309
##### Counts
Group Id: OG001
Value: 293
##### Categories
##### Measurements
Group Id: OG000
Value: 0.196
Spread: 3.132
##### Measurements
Group Id: OG001
Value: 0.005
Spread: 0.368
##### Classes
Title: Day 11
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 253
##### Counts
Group Id: OG001
Value: 218
##### Categories
##### Measurements
Group Id: OG000
Value: 0.024
Spread: 0.042
##### Measurements
Group Id: OG001
Value: 0.028
Spread: 0.053
##### Classes
Title: Day 15
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 235
##### Counts
Group Id: OG001
Value: 248
##### Categories
##### Measurements
Group Id: OG000
Value: 0.158
Spread: 1.913
##### Measurements
Group Id: OG001
Value: -0.058
Spread: 1.028
##### Classes
Title: Day 29
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 176
##### Counts
Group Id: OG001
Value: 216
##### Categories
##### Measurements
Group Id: OG000
Value: 0.040
Spread: 0.073
##### Measurements
Group Id: OG001
Value: 0.029
Spread: 0.054
#### Outcome Measures
Type: SECONDARY
Title: Change From Baseline in Eosinophils
Description:
Blood to evaluate eosinophils was collected at Days 1, 3, 5, 8, and 11
while participants were inpatient, and at Days 15 and 29, with the Day 1
assessment serving as baseline. Participants who had been discharged had
blood collected if infection control measures allowed for in-person
visits after discharge.
Population Description:
The safety population includes all treated participants with available
data at baseline and the post baseline assessment point, analyzed as
treated.
Reporting Status: POSTED
Param Type: MEAN
Dispersion Type: Standard Deviation
Unit Of Measure: 10^9 cells/liter
Time Frame: Days 1, 3, 5, 8, 11, 15 and 29
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 456
##### Counts
Group Id: OG001
Value: 455
##### Classes
Title: Day 3
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 456
##### Counts
Group Id: OG001
Value: 455
##### Categories
##### Measurements
Group Id: OG000
Value: 0.634
Spread: 10.614
##### Measurements
Group Id: OG001
Value: 0.016
Spread: 0.727
##### Classes
Title: Day 5
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 397
##### Counts
Group Id: OG001
Value: 387
##### Categories
##### Measurements
Group Id: OG000
Value: 0.666
Spread: 11.977
##### Measurements
Group Id: OG001
Value: -0.066
Spread: 2.807
##### Classes
Title: Day 8
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 311
##### Counts
Group Id: OG001
Value: 293
##### Categories
##### Measurements
Group Id: OG000
Value: 0.596
Spread: 8.875
##### Measurements
Group Id: OG001
Value: -0.221
Spread: 4.108
##### Classes
Title: Day 11
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 254
##### Counts
Group Id: OG001
Value: 218
##### Categories
##### Measurements
Group Id: OG000
Value: 0.093
Spread: 0.190
##### Measurements
Group Id: OG001
Value: -0.088
Spread: 2.973
##### Classes
Title: Day 15
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 237
##### Counts
Group Id: OG001
Value: 251
##### Categories
##### Measurements
Group Id: OG000
Value: 1.992
Spread: 20.365
##### Measurements
Group Id: OG001
Value: -0.420
Spread: 5.378
##### Classes
Title: Day 29
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 176
##### Counts
Group Id: OG001
Value: 217
##### Categories
##### Measurements
Group Id: OG000
Value: 0.241
Spread: 0.324
##### Measurements
Group Id: OG001
Value: 0.211
Spread: 0.267
#### Outcome Measures
Type: SECONDARY
Title: Change in National Early Warning Score (NEWS) From Baseline
Description:
The NEW score has demonstrated an ability to discriminate patients at
risk of poor outcomes. This score is based on 7 clinical parameters
(respiration rate, oxygen saturation, any supplemental oxygen,
temperature, systolic blood pressure, heart rate, level of
consciousness). The NEW Score is being used as an efficacy measure. The
minimum score is 0, representing the better outcome, and the maximum
value is 19, representing the worse outcome.
Population Description:
The intent-to-treat (ITT) population includes all participants who were
randomized with data at baseline and at each timepoint.
Reporting Status: POSTED
Param Type: MEAN
Dispersion Type: Standard Deviation
Unit Of Measure: units on a scale
Time Frame: Days 1, 3, 5, 8, 11, 15, 22, and 29
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 499
##### Counts
Group Id: OG001
Value: 502
##### Classes
Title: Day 3
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 499
##### Counts
Group Id: OG001
Value: 502
##### Categories
##### Measurements
Group Id: OG000
Value: 0.1
Spread: 2.8
##### Measurements
Group Id: OG001
Value: -0.3
Spread: 2.6
##### Classes
Title: Day 5
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 447
##### Counts
Group Id: OG001
Value: 438
##### Categories
##### Measurements
Group Id: OG000
Value: 0.3
Spread: 3.3
##### Measurements
Group Id: OG001
Value: -0.4
Spread: 2.9
##### Classes
Title: Day 8
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 348
##### Counts
Group Id: OG001
Value: 321
##### Categories
##### Measurements
Group Id: OG000
Value: -0.3
Spread: 3.8
##### Measurements
Group Id: OG001
Value: -0.5
Spread: 3.2
##### Classes
Title: Day 11
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 291
##### Counts
Group Id: OG001
Value: 254
##### Categories
##### Measurements
Group Id: OG000
Value: -0.3
Spread: 4.1
##### Measurements
Group Id: OG001
Value: -0.5
Spread: 3.5
##### Classes
Title: Day 15
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 290
##### Counts
Group Id: OG001
Value: 301
##### Categories
##### Measurements
Group Id: OG000
Value: -1.4
Spread: 4.2
##### Measurements
Group Id: OG001
Value: -1.7
Spread: 3.6
##### Classes
Title: Day 22
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 151
##### Counts
Group Id: OG001
Value: 120
##### Categories
##### Measurements
Group Id: OG000
Value: -1.4
Spread: 4.0
##### Measurements
Group Id: OG001
Value: -1.7
Spread: 4.1
##### Classes
Title: Day 29
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 221
##### Counts
Group Id: OG001
Value: 251
##### Categories
##### Measurements
Group Id: OG000
Value: -3.2
Spread: 4.0
##### Measurements
Group Id: OG001
Value: -3.3
Spread: 3.2
#### Outcome Measures
Type: SECONDARY
Title:
Percentage of Participants at Each Clinical Status Using Ordinal Scale
at Day 1
Description:
The ordinal scale is an assessment of the clinical status at the first
assessment of a given study day. The scale is as follows: 8) Death; 7)
Hospitalized, on invasive mechanical ventilation or extracorporeal
membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
ventilation or high flow oxygen devices; 5) Hospitalized, requiring
supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
- requiring ongoing medical care (COVID-19 related or otherwise); 3)
Hospitalized, not requiring supplemental oxygen - no longer requires
ongoing medical care; 2) Not hospitalized, limitation on activities
and/or requiring home oxygen; 1) Not hospitalized, no limitations on
activities.
Population Description:
The intent-to-treat (ITT) population includes all participants who were
randomized
Reporting Status: POSTED
Param Type: NUMBER
Dispersion Type: 95% Confidence Interval
Unit Of Measure: percentage of participants
Time Frame: Day 1
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 521
##### Counts
Group Id: OG001
Value: 541
##### Classes
Title: Death at or before study Visit
##### Categories
##### Measurements
Group Id: OG000
Value: 0
Lower Limit: 0
Upper Limit: 1
##### Measurements
Group Id: OG001
Value: 0
Lower Limit: 0
Upper Limit: 1
##### Classes
Title: Hospitalized, on invasive mech. vent. or ECMO
##### Categories
##### Measurements
Group Id: OG000
Value: 30
Lower Limit: 26
Upper Limit: 34
##### Measurements
Group Id: OG001
Value: 24
Lower Limit: 21
Upper Limit: 28
##### Classes
Title: Hospitalized, on non-invasive vent./high flow O2
##### Categories
##### Measurements
Group Id: OG000
Value: 19
Lower Limit: 16
Upper Limit: 22
##### Measurements
Group Id: OG001
Value: 18
Lower Limit: 15
Upper Limit: 21
##### Classes
Title: Hospitalized, requiring supplemental oxygen
##### Categories
##### Measurements
Group Id: OG000
Value: 39
Lower Limit: 35
Upper Limit: 43
##### Measurements
Group Id: OG001
Value: 43
Lower Limit: 39
Upper Limit: 47
##### Classes
Title: Hospitalized, not on O2, requiring ongoing care
##### Categories
##### Measurements
Group Id: OG000
Value: 12
Lower Limit: 10
Upper Limit: 15
##### Measurements
Group Id: OG001
Value: 14
Lower Limit: 11
Upper Limit: 17
##### Classes
Title: Hospitalized, not requiring O2, no longer req care
##### Categories
##### Measurements
Group Id: OG000
Value: 0
Lower Limit: 0
Upper Limit: 1
##### Measurements
Group Id: OG001
Value: 0
Lower Limit: 0
Upper Limit: 1
##### Classes
Title: Not hospitalized, limit on activities/req home O2
##### Categories
##### Measurements
Group Id: OG000
Value: 0
Lower Limit: 0
Upper Limit: 1
##### Measurements
Group Id: OG001
Value: 0
Lower Limit: 0
Upper Limit: 1
##### Classes
Title: Not hospitalized, no limitations on activities
##### Categories
##### Measurements
Group Id: OG000
Value: 0
Lower Limit: 0
Upper Limit: 1
##### Measurements
Group Id: OG001
Value: 0
Lower Limit: 0
Upper Limit: 1
##### Classes
Title: No clinical status score reported - Hospitalized
##### Categories
##### Measurements
Group Id: OG000
Value: 0
Lower Limit: 0
Upper Limit: 1
##### Measurements
Group Id: OG001
Value: 1
Lower Limit: 0
Upper Limit: 2
##### Classes
Title: No clinical status score reported - Discharged
##### Categories
##### Measurements
Group Id: OG000
Value: 0
Lower Limit: 0
Upper Limit: 1
##### Measurements
Group Id: OG001
Value: 0
Lower Limit: 0
Upper Limit: 1
##### Classes
Title: No clinical status score reported - Discontinued
##### Categories
##### Measurements
Group Id: OG000
Value: 1
Lower Limit: 0
Upper Limit: 2
##### Measurements
Group Id: OG001
Value: 1
Lower Limit: 0
Upper Limit: 2
#### Outcome Measures
Type: SECONDARY
Title:
Percentage of Participants at Each Clinical Status Using Ordinal Scale
at Day 3
Description:
The ordinal scale is an assessment of the clinical status at the first
assessment of a given study day. The scale is as follows: 8) Death; 7)
Hospitalized, on invasive mechanical ventilation or extracorporeal
membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
ventilation or high flow oxygen devices; 5) Hospitalized, requiring
supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
- requiring ongoing medical care (COVID-19 related or otherwise); 3)
Hospitalized, not requiring supplemental oxygen - no longer requires
ongoing medical care; 2) Not hospitalized, limitation on activities
and/or requiring home oxygen; 1) Not hospitalized, no limitations on
activities.
Population Description:
The intent-to-treat (ITT) population includes all participants who were
randomized
Reporting Status: POSTED
Param Type: NUMBER
Dispersion Type: 95% Confidence Interval
Unit Of Measure: percentage of participants
Time Frame: Day 3
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 521
##### Counts
Group Id: OG001
Value: 541
##### Classes
Title: Death at or before study Visit
##### Categories
##### Measurements
Group Id: OG000
Value: 1
Lower Limit: 1
Upper Limit: 3
##### Measurements
Group Id: OG001
Value: 1
Lower Limit: 0
Upper Limit: 2
##### Classes
Title: Hospitalized, on invasive mech. vent. or ECMO
##### Categories
##### Measurements
Group Id: OG000
Value: 36
Lower Limit: 32
Upper Limit: 40
##### Measurements
Group Id: OG001
Value: 28
Lower Limit: 25
Upper Limit: 32
##### Classes
Title: Hospitalized, on non-invasive vent./high flow O2
##### Categories
##### Measurements
Group Id: OG000
Value: 17
Lower Limit: 14
Upper Limit: 21
##### Measurements
Group Id: OG001
Value: 16
Lower Limit: 13
Upper Limit: 19
##### Classes
Title: Hospitalized, requiring supplemental oxygen
##### Categories
##### Measurements
Group Id: OG000
Value: 32
Lower Limit: 29
Upper Limit: 37
##### Measurements
Group Id: OG001
Value: 37
Lower Limit: 33
Upper Limit: 41
##### Classes
Title: Hospitalized, not on O2, requiring ongoing care
##### Categories
##### Measurements
Group Id: OG000
Value: 12
Lower Limit: 9
Upper Limit: 15
##### Measurements
Group Id: OG001
Value: 13
Lower Limit: 10
Upper Limit: 16
##### Classes
Title: Hospitalized, not requiring O2, no longer req care
##### Categories
##### Measurements
Group Id: OG000
Value: 0.4
Lower Limit: 0
Upper Limit: 1
##### Measurements
Group Id: OG001
Value: 0.2
Lower Limit: 0
Upper Limit: 1
##### Classes
Title: Not hospitalized, limit on activities/req home O2
##### Categories
##### Measurements
Group Id: OG000
Value: 0
Lower Limit: 0
Upper Limit: 1
##### Measurements
Group Id: OG001
Value: 0
Lower Limit: 0
Upper Limit: 1
##### Classes
Title: Not hospitalized, no limitations on activities
##### Categories
##### Measurements
Group Id: OG000
Value: 0
Lower Limit: 0
Upper Limit: 1
##### Measurements
Group Id: OG001
Value: 0.4
Lower Limit: 0
Upper Limit: 1
##### Classes
Title: No clinical status score reported - Hospitalized
##### Categories
##### Measurements
Group Id: OG000
Value: 0
Lower Limit: 0
Upper Limit: 1
##### Measurements
Group Id: OG001
Value: 0
Lower Limit: 0
Upper Limit: 1
##### Classes
Title: No clinical status score reported - Discharged
##### Categories
##### Measurements
Group Id: OG000
Value: 0.2
Lower Limit: 0
Upper Limit: 1
##### Measurements
Group Id: OG001
Value: 2
Lower Limit: 1
Upper Limit: 4
##### Classes
Title: No clinical status score reported - Discontinued
##### Categories
##### Measurements
Group Id: OG000
Value: 1
Lower Limit: 0
Upper Limit: 2
##### Measurements
Group Id: OG001
Value: 2
Lower Limit: 1
Upper Limit: 4
#### Outcome Measures
Type: SECONDARY
Title:
Percentage of Participants at Each Clinical Status Using Ordinal Scale
at Day 5
Description:
The ordinal scale is an assessment of the clinical status at the first
assessment of a given study day. The scale is as follows: 8) Death; 7)
Hospitalized, on invasive mechanical ventilation or extracorporeal
membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
ventilation or high flow oxygen devices; 5) Hospitalized, requiring
supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
- requiring ongoing medical care (COVID-19 related or otherwise); 3)
Hospitalized, not requiring supplemental oxygen - no longer requires
ongoing medical care; 2) Not hospitalized, limitation on activities
and/or requiring home oxygen; 1) Not hospitalized, no limitations on
activities.
Population Description:
The intent-to-treat (ITT) population includes all participants who were
randomized
Reporting Status: POSTED
Param Type: NUMBER
Dispersion Type: 95% Confidence Interval
Unit Of Measure: percentage of participants
Time Frame: Day 5
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 521
##### Counts
Group Id: OG001
Value: 541
##### Classes
Title: Death at or before study Visit
##### Categories
##### Measurements
Group Id: OG000
Value: 2
Lower Limit: 1
Upper Limit: 4
##### Measurements
Group Id: OG001
Value: 2
Lower Limit: 1
Upper Limit: 4
##### Classes
Title: Hospitalized, on invasive mech. vent. or ECMO
##### Categories
##### Measurements
Group Id: OG000
Value: 37
Lower Limit: 33
Upper Limit: 41
##### Measurements
Group Id: OG001
Value: 28
Lower Limit: 24
Upper Limit: 32
##### Classes
Title: Hospitalized, on non-invasive vent./high flow O2
##### Categories
##### Measurements
Group Id: OG000
Value: 14
Lower Limit: 12
Upper Limit: 18
##### Measurements
Group Id: OG001
Value: 12
Lower Limit: 9
Upper Limit: 15
##### Classes
Title: Hospitalized, requiring supplemental oxygen
##### Categories
##### Measurements
Group Id: OG000
Value: 26
Lower Limit: 23
Upper Limit: 30
##### Measurements
Group Id: OG001
Value: 28
Lower Limit: 24
Upper Limit: 31
##### Classes
Title: Hospitalized, not on O2, requiring ongoing care
##### Categories
##### Measurements
Group Id: OG000
Value: 11
Lower Limit: 8
Upper Limit: 13
##### Measurements
Group Id: OG001
Value: 15
Lower Limit: 12
Upper Limit: 18
##### Classes
Title: Hospitalized, not requiring O2, no longer req care
##### Categories
##### Measurements
Group Id: OG000
Value: 1
Lower Limit: 0
Upper Limit: 2
##### Measurements
Group Id: OG001
Value: 1
Lower Limit: 0
Upper Limit: 2
##### Classes
Title: Not hospitalized, limit on activities/req home O2
##### Categories
##### Measurements
Group Id: OG000
Value: 0
Lower Limit: 0
Upper Limit: 1
##### Measurements
Group Id: OG001
Value: 0.2
Lower Limit: 0
Upper Limit: 1
##### Classes
Title: Not hospitalized, no limitations on activities
##### Categories
##### Measurements
Group Id: OG000
Value: 0.2
Lower Limit: 0
Upper Limit: 1
##### Measurements
Group Id: OG001
Value: 0
Lower Limit: 0
Upper Limit: 1
##### Classes
Title: No clinical status score reported - Hospitalized
##### Categories
##### Measurements
Group Id: OG000
Value: 0
Lower Limit: 0
Upper Limit: 1
##### Measurements
Group Id: OG001
Value: 0
Lower Limit: 0
Upper Limit: 1
##### Classes
Title: No clinical status score reported - Discharged
##### Categories
##### Measurements
Group Id: OG000
Value: 7
Lower Limit: 5
Upper Limit: 9
##### Measurements
Group Id: OG001
Value: 12
Lower Limit: 9
Upper Limit: 15
##### Classes
Title: No clinical status score reported - Discontinued
##### Categories
##### Measurements
Group Id: OG000
Value: 2
Lower Limit: 1
Upper Limit: 3
##### Measurements
Group Id: OG001
Value: 3
Lower Limit: 2
Upper Limit: 5
#### Outcome Measures
Type: SECONDARY
Title:
Percentage of Participants at Each Clinical Status Using Ordinal Scale
at Day 8
Description:
The ordinal scale is an assessment of the clinical status at the first
assessment of a given study day. The scale is as follows: 8) Death; 7)
Hospitalized, on invasive mechanical ventilation or extracorporeal
membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
ventilation or high flow oxygen devices; 5) Hospitalized, requiring
supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
- requiring ongoing medical care (COVID-19 related or otherwise); 3)
Hospitalized, not requiring supplemental oxygen - no longer requires
ongoing medical care; 2) Not hospitalized, limitation on activities
and/or requiring home oxygen; 1) Not hospitalized, no limitations on
activities.
Population Description:
The intent-to-treat (ITT) population includes all participants who were
randomized
Reporting Status: POSTED
Param Type: NUMBER
Dispersion Type: 95% Confidence Interval
Unit Of Measure: percentage of participants
Time Frame: Day 8
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 521
##### Counts
Group Id: OG001
Value: 541
##### Classes
Title: Death at or before study Visit
##### Categories
##### Measurements
Group Id: OG000
Value: 7
Lower Limit: 5
Upper Limit: 9
##### Measurements
Group Id: OG001
Value: 3
Lower Limit: 2
Upper Limit: 5
##### Classes
Title: Hospitalized, on invasive mech. vent. or ECMO
##### Categories
##### Measurements
Group Id: OG000
Value: 33
Lower Limit: 29
Upper Limit: 37
##### Measurements
Group Id: OG001
Value: 24
Lower Limit: 21
Upper Limit: 28
##### Classes
Title: Hospitalized, on non-invasive vent./high flow O2
##### Categories
##### Measurements
Group Id: OG000
Value: 9
Lower Limit: 7
Upper Limit: 12
##### Measurements
Group Id: OG001
Value: 9
Lower Limit: 7
Upper Limit: 12
##### Classes
Title: Hospitalized, requiring supplemental oxygen
##### Categories
##### Measurements
Group Id: OG000
Value: 15
Lower Limit: 13
Upper Limit: 19
##### Measurements
Group Id: OG001
Value: 17
Lower Limit: 14
Upper Limit: 21
##### Classes
Title: Hospitalized, not on O2, requiring ongoing care
##### Categories
##### Measurements
Group Id: OG000
Value: 10
Lower Limit: 8
Upper Limit: 13
##### Measurements
Group Id: OG001
Value: 11
Lower Limit: 9
Upper Limit: 14
##### Classes
Title: Hospitalized, not requiring O2, no longer req care
##### Categories
##### Measurements
Group Id: OG000
Value: 1
Lower Limit: 1
Upper Limit: 3
##### Measurements
Group Id: OG001
Value: 1
Lower Limit: 1
Upper Limit: 3
##### Classes
Title: Not hospitalized, limit on activities/req home O2
##### Categories
##### Measurements
Group Id: OG000
Value: 0
Lower Limit: 0
Upper Limit: 1
##### Measurements
Group Id: OG001
Value: 0.2
Lower Limit: 0
Upper Limit: 1
##### Classes
Title: Not hospitalized, no limitations on activities
##### Categories
##### Measurements
Group Id: OG000
Value: 0.2
Lower Limit: 0
Upper Limit: 1
##### Measurements
Group Id: OG001
Value: 0
Lower Limit: 0
Upper Limit: 1
##### Classes
Title: No clinical status score reported - Hospitalized
##### Categories
##### Measurements
Group Id: OG000
Value: 0
Lower Limit: 0
Upper Limit: 1
##### Measurements
Group Id: OG001
Value: 0.4
Lower Limit: 0
Upper Limit: 1
##### Classes
Title: No clinical status score reported - Discharged
##### Categories
##### Measurements
Group Id: OG000
Value: 22
Lower Limit: 19
Upper Limit: 26
##### Measurements
Group Id: OG001
Value: 30
Lower Limit: 27
Upper Limit: 34
##### Classes
Title: No clinical status score reported - Discontinued
##### Categories
##### Measurements
Group Id: OG000
Value: 2
Lower Limit: 1
Upper Limit: 3
##### Measurements
Group Id: OG001
Value: 4
Lower Limit: 2
Upper Limit: 5
#### Outcome Measures
Type: SECONDARY
Title:
Percentage of Participants at Each Clinical Status Using Ordinal Scale
at Day 11
Description:
The ordinal scale is an assessment of the clinical status at the first
assessment of a given study day. The scale is as follows: 8) Death; 7)
Hospitalized, on invasive mechanical ventilation or extracorporeal
membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
ventilation or high flow oxygen devices; 5) Hospitalized, requiring
supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
- requiring ongoing medical care (COVID-19 related or otherwise); 3)
Hospitalized, not requiring supplemental oxygen - no longer requires
ongoing medical care; 2) Not hospitalized, limitation on activities
and/or requiring home oxygen; 1) Not hospitalized, no limitations on
activities.
Population Description:
The intent-to-treat (ITT) population includes all participants who were
randomized
Reporting Status: POSTED
Param Type: NUMBER
Dispersion Type: 95% Confidence Interval
Unit Of Measure: percentage of participants
Time Frame: Day 11
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 521
##### Counts
Group Id: OG001
Value: 541
##### Classes
Title: Death at or before study Visit
##### Categories
##### Measurements
Group Id: OG000
Value: 8
Lower Limit: 6
Upper Limit: 11
##### Measurements
Group Id: OG001
Value: 4
Lower Limit: 3
Upper Limit: 6
##### Classes
Title: Hospitalized, on invasive mech. vent. or ECMO
##### Categories
##### Measurements
Group Id: OG000
Value: 28
Lower Limit: 25
Upper Limit: 32
##### Measurements
Group Id: OG001
Value: 22
Lower Limit: 19
Upper Limit: 26
##### Classes
Title: Hospitalized, on non-invasive vent./high flow O2
##### Categories
##### Measurements
Group Id: OG000
Value: 7
Lower Limit: 5
Upper Limit: 10
##### Measurements
Group Id: OG001
Value: 6
Lower Limit: 4
Upper Limit: 8
##### Classes
Title: Hospitalized, requiring supplemental oxygen
##### Categories
##### Measurements
Group Id: OG000
Value: 13
Lower Limit: 10
Upper Limit: 16
##### Measurements
Group Id: OG001
Value: 11
Lower Limit: 9
Upper Limit: 14
##### Classes
Title: Hospitalized, not on O2, requiring ongoing care
##### Categories
##### Measurements
Group Id: OG000
Value: 6
Lower Limit: 5
Upper Limit: 9
##### Measurements
Group Id: OG001
Value: 7
Lower Limit: 5
Upper Limit: 9
##### Classes
Title: Hospitalized, not requiring O2, no longer req care
##### Categories
##### Measurements
Group Id: OG000
Value: 2
Lower Limit: 1
Upper Limit: 4
##### Measurements
Group Id: OG001
Value: 2
Lower Limit: 1
Upper Limit: 4
##### Classes
Title: Not hospitalized, limit on activities/req home O2
##### Categories
##### Measurements
Group Id: OG000
Value: 0.4
Lower Limit: 0
Upper Limit: 1
##### Measurements
Group Id: OG001
Value: 0.4
Lower Limit: 0
Upper Limit: 1
##### Classes
Title: Not hospitalized, no limitations on activities
##### Categories
##### Measurements
Group Id: OG000
Value: 0.2
Lower Limit: 0
Upper Limit: 1
##### Measurements
Group Id: OG001
Value: 0
Lower Limit: 0
Upper Limit: 1
##### Classes
Title: No clinical status score reported - Hospitalized
##### Categories
##### Measurements
Group Id: OG000
Value: 0
Lower Limit: 0
Upper Limit: 1
##### Measurements
Group Id: OG001
Value: 0
Lower Limit: 0
Upper Limit: 1
##### Classes
Title: No clinical status score reported - Discharged
##### Categories
##### Measurements
Group Id: OG000
Value: 33
Lower Limit: 29
Upper Limit: 37
##### Measurements
Group Id: OG001
Value: 44
Lower Limit: 40
Upper Limit: 48
##### Classes
Title: No clinical status score reported - Discontinued
##### Categories
##### Measurements
Group Id: OG000
Value: 2
Lower Limit: 1
Upper Limit: 4
##### Measurements
Group Id: OG001
Value: 4
Lower Limit: 3
Upper Limit: 6
#### Outcome Measures
Type: SECONDARY
Title:
Percentage of Participants at Each Clinical Status Using Ordinal Scale
at Day 15
Description:
The ordinal scale is an assessment of the clinical status at the first
assessment of a given study day. The scale is as follows: 8) Death; 7)
Hospitalized, on invasive mechanical ventilation or extracorporeal
membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
ventilation or high flow oxygen devices; 5) Hospitalized, requiring
supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
- requiring ongoing medical care (COVID-19 related or otherwise); 3)
Hospitalized, not requiring supplemental oxygen - no longer requires
ongoing medical care; 2) Not hospitalized, limitation on activities
and/or requiring home oxygen; 1) Not hospitalized, no limitations on
activities.
Population Description:
The intent-to-treat (ITT) population includes all participants who were
randomized
Reporting Status: POSTED
Param Type: NUMBER
Dispersion Type: 95% Confidence Interval
Unit Of Measure: percentage of participants
Time Frame: Day 15
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 521
##### Counts
Group Id: OG001
Value: 541
##### Classes
Title: Death at or before study Visit
##### Categories
##### Measurements
Group Id: OG000
Value: 11
Lower Limit: 9
Upper Limit: 14
##### Measurements
Group Id: OG001
Value: 6
Lower Limit: 5
Upper Limit: 9
##### Classes
Title: Hospitalized, on invasive mech. vent. or ECMO
##### Categories
##### Measurements
Group Id: OG000
Value: 22
Lower Limit: 19
Upper Limit: 26
##### Measurements
Group Id: OG001
Value: 15
Lower Limit: 13
Upper Limit: 19
##### Classes
Title: Hospitalized, on non-invasive vent./high flow O2
##### Categories
##### Measurements
Group Id: OG000
Value: 4
Lower Limit: 3
Upper Limit: 6
##### Measurements
Group Id: OG001
Value: 4
Lower Limit: 3
Upper Limit: 6
##### Classes
Title: Hospitalized, requiring supplemental oxygen
##### Categories
##### Measurements
Group Id: OG000
Value: 11
Lower Limit: 9
Upper Limit: 14
##### Measurements
Group Id: OG001
Value: 10
Lower Limit: 8
Upper Limit: 13
##### Classes
Title: Hospitalized, not on O2, requiring ongoing care
##### Categories
##### Measurements
Group Id: OG000
Value: 6
Lower Limit: 5
Upper Limit: 9
##### Measurements
Group Id: OG001
Value: 7
Lower Limit: 5
Upper Limit: 9
##### Classes
Title: Hospitalized, not requiring O2, no longer req care
##### Categories
##### Measurements
Group Id: OG000
Value: 2
Lower Limit: 1
Upper Limit: 3
##### Measurements
Group Id: OG001
Value: 3
Lower Limit: 2
Upper Limit: 4
##### Classes
Title: Not hospitalized, limit on activities/req home O2
##### Categories
##### Measurements
Group Id: OG000
Value: 17
Lower Limit: 14
Upper Limit: 21
##### Measurements
Group Id: OG001
Value: 19
Lower Limit: 16
Upper Limit: 22
##### Classes
Title: Not hospitalized, no limitations on activities
##### Categories
##### Measurements
Group Id: OG000
Value: 22
Lower Limit: 19
Upper Limit: 26
##### Measurements
Group Id: OG001
Value: 29
Lower Limit: 25
Upper Limit: 33
##### Classes
Title: No clinical status score reported - Hospitalized
##### Categories
##### Measurements
Group Id: OG000
Value: 0
Lower Limit: 0
Upper Limit: 1
##### Measurements
Group Id: OG001
Value: 0
Lower Limit: 0
Upper Limit: 1
##### Classes
Title: No clinical status score reported - Discharged
##### Categories
##### Measurements
Group Id: OG000
Value: 2
Lower Limit: 1
Upper Limit: 3
##### Measurements
Group Id: OG001
Value: 2
Lower Limit: 1
Upper Limit: 4
##### Classes
Title: No clinical status score reported - Discontinued
##### Categories
##### Measurements
Group Id: OG000
Value: 3
Lower Limit: 2
Upper Limit: 4
##### Measurements
Group Id: OG001
Value: 5
Lower Limit: 3
Upper Limit: 7
#### Outcome Measures
Type: SECONDARY
Title:
Percentage of Participants at Each Clinical Status Using Ordinal Scale
at Day 22
Description:
The ordinal scale is an assessment of the clinical status at the first
assessment of a given study day. The scale is as follows: 8) Death; 7)
Hospitalized, on invasive mechanical ventilation or extracorporeal
membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
ventilation or high flow oxygen devices; 5) Hospitalized, requiring
supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
- requiring ongoing medical care (COVID-19 related or otherwise); 3)
Hospitalized, not requiring supplemental oxygen - no longer requires
ongoing medical care; 2) Not hospitalized, limitation on activities
and/or requiring home oxygen; 1) Not hospitalized, no limitations on
activities.
Population Description:
The intent-to-treat (ITT) population includes all participants who were
randomized
Reporting Status: POSTED
Param Type: NUMBER
Dispersion Type: 95% Confidence Interval
Unit Of Measure: percentage of participants
Time Frame: Day 22
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 521
##### Counts
Group Id: OG001
Value: 541
##### Classes
Title: Death at or before study Visit
##### Categories
##### Measurements
Group Id: OG000
Value: 13
Lower Limit: 10
Upper Limit: 16
##### Measurements
Group Id: OG001
Value: 9
Lower Limit: 7
Upper Limit: 12
##### Classes
Title: Hospitalized, on invasive mech. vent. or ECMO
##### Categories
##### Measurements
Group Id: OG000
Value: 14
Lower Limit: 12
Upper Limit: 18
##### Measurements
Group Id: OG001
Value: 9
Lower Limit: 7
Upper Limit: 12
##### Classes
Title: Hospitalized, on non-invasive vent./high flow O2
##### Categories
##### Measurements
Group Id: OG000
Value: 2
Lower Limit: 1
Upper Limit: 4
##### Measurements
Group Id: OG001
Value: 2
Lower Limit: 1
Upper Limit: 4
##### Classes
Title: Hospitalized, requiring supplemental oxygen
##### Categories
##### Measurements
Group Id: OG000
Value: 8
Lower Limit: 6
Upper Limit: 11
##### Measurements
Group Id: OG001
Value: 5
Lower Limit: 4
Upper Limit: 8
##### Classes
Title: Hospitalized, not on O2, requiring ongoing care
##### Categories
##### Measurements
Group Id: OG000
Value: 5
Lower Limit: 4
Upper Limit: 8
##### Measurements
Group Id: OG001
Value: 6
Lower Limit: 4
Upper Limit: 8
##### Classes
Title: Hospitalized, not requiring O2, no longer req care
##### Categories
##### Measurements
Group Id: OG000
Value: 1
Lower Limit: 0
Upper Limit: 2
##### Measurements
Group Id: OG001
Value: 1
Lower Limit: 1
Upper Limit: 3
##### Classes
Title: Not hospitalized, limit on activities/req home O2
##### Categories
##### Measurements
Group Id: OG000
Value: 18
Lower Limit: 15
Upper Limit: 22
##### Measurements
Group Id: OG001
Value: 19
Lower Limit: 16
Upper Limit: 23
##### Classes
Title: Not hospitalized, no limitations on activities
##### Categories
##### Measurements
Group Id: OG000
Value: 32
Lower Limit: 29
Upper Limit: 37
##### Measurements
Group Id: OG001
Value: 39
Lower Limit: 35
Upper Limit: 43
##### Classes
Title: No clinical status score reported - Hospitalized
##### Categories
##### Measurements
Group Id: OG000
Value: 0
Lower Limit: 0
Upper Limit: 1
##### Measurements
Group Id: OG001
Value: 0
Lower Limit: 0
Upper Limit: 1
##### Classes
Title: No clinical status score reported - Discharged
##### Categories
##### Measurements
Group Id: OG000
Value: 2
Lower Limit: 1
Upper Limit: 4
##### Measurements
Group Id: OG001
Value: 3
Lower Limit: 2
Upper Limit: 5
##### Classes
Title: No clinical status score reported - Discontinued
##### Categories
##### Measurements
Group Id: OG000
Value: 4
Lower Limit: 2
Upper Limit: 6
##### Measurements
Group Id: OG001
Value: 6
Lower Limit: 4
Upper Limit: 8
##### Classes
Title: Completed study without reporting score
##### Categories
##### Measurements
Group Id: OG000
Value: 0
Lower Limit: 0
Upper Limit: 1
##### Measurements
Group Id: OG001
Value: 0.2
Lower Limit: 0
Upper Limit: 1
#### Outcome Measures
Type: SECONDARY
Title:
Percentage of Participants at Each Clinical Status Using Ordinal Scale
at Day 29
Description:
The ordinal scale is an assessment of the clinical status at the first
assessment of a given study day. The scale is as follows: 8) Death; 7)
Hospitalized, on invasive mechanical ventilation or extracorporeal
membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
ventilation or high flow oxygen devices; 5) Hospitalized, requiring
supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
- requiring ongoing medical care (COVID-19 related or otherwise); 3)
Hospitalized, not requiring supplemental oxygen - no longer requires
ongoing medical care; 2) Not hospitalized, limitation on activities
and/or requiring home oxygen; 1) Not hospitalized, no limitations on
activities.
Population Description:
The intent-to-treat (ITT) population includes all participants who were
randomized
Reporting Status: POSTED
Param Type: NUMBER
Dispersion Type: 95% Confidence Interval
Unit Of Measure: percentage of participants
Time Frame: Day 29
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 521
##### Counts
Group Id: OG001
Value: 541
##### Classes
Title: Death at or before study Visit
##### Categories
##### Measurements
Group Id: OG000
Value: 15
Lower Limit: 12
Upper Limit: 18
##### Measurements
Group Id: OG001
Value: 11
Lower Limit: 8
Upper Limit: 14
##### Classes
Title: Hospitalized, on invasive mech. vent. or ECMO
##### Categories
##### Measurements
Group Id: OG000
Value: 9
Lower Limit: 7
Upper Limit: 11
##### Measurements
Group Id: OG001
Value: 6
Lower Limit: 4
Upper Limit: 8
##### Classes
Title: Hospitalized, on non-invasive vent./high flow O2
##### Categories
##### Measurements
Group Id: OG000
Value: 2
Lower Limit: 1
Upper Limit: 3
##### Measurements
Group Id: OG001
Value: 1
Lower Limit: 0
Upper Limit: 2
##### Classes
Title: Hospitalized, requiring supplemental oxygen
##### Categories
##### Measurements
Group Id: OG000
Value: 4
Lower Limit: 3
Upper Limit: 6
##### Measurements
Group Id: OG001
Value: 4
Lower Limit: 3
Upper Limit: 6
##### Classes
Title: Hospitalized, not on O2, requiring ongoing care
##### Categories
##### Measurements
Group Id: OG000
Value: 3
Lower Limit: 2
Upper Limit: 5
##### Measurements
Group Id: OG001
Value: 3
Lower Limit: 2
Upper Limit: 5
##### Classes
Title: Hospitalized, not requiring O2, no longer req care
##### Categories
##### Measurements
Group Id: OG000
Value: 1
Lower Limit: 0
Upper Limit: 2
##### Measurements
Group Id: OG001
Value: 1
Lower Limit: 0
Upper Limit: 2
##### Classes
Title: Not hospitalized, limit on activities/req home O2
##### Categories
##### Measurements
Group Id: OG000
Value: 19
Lower Limit: 16
Upper Limit: 23
##### Measurements
Group Id: OG001
Value: 20
Lower Limit: 17
Upper Limit: 23
##### Classes
Title: Not hospitalized, no limitations on activities
##### Categories
##### Measurements
Group Id: OG000
Value: 36
Lower Limit: 32
Upper Limit: 41
##### Measurements
Group Id: OG001
Value: 46
Lower Limit: 42
Upper Limit: 50
##### Classes
Title: No clinical status score reported - Hospitalized
##### Categories
##### Measurements
Group Id: OG000
Value: 0.2
Lower Limit: 0
Upper Limit: 1
##### Measurements
Group Id: OG001
Value: 0
Lower Limit: 0
Upper Limit: 1
##### Classes
Title: No clinical status score reported - Discharged
##### Categories
##### Measurements
Group Id: OG000
Value: 3
Lower Limit: 2
Upper Limit: 5
##### Measurements
Group Id: OG001
Value: 1
Lower Limit: 1
Upper Limit: 3
##### Classes
Title: No clinical status score reported - Discontinued
##### Categories
##### Measurements
Group Id: OG000
Value: 5
Lower Limit: 3
Upper Limit: 7
##### Measurements
Group Id: OG001
Value: 7
Lower Limit: 5
Upper Limit: 9
##### Classes
Title: Completed study without reporting score
##### Categories
##### Measurements
Group Id: OG000
Value: 3
Lower Limit: 2
Upper Limit: 4
##### Measurements
Group Id: OG001
Value: 2
Lower Limit: 1
Upper Limit: 4
#### Outcome Measures
Type: SECONDARY
Title:
Percentage of Participants Reporting Grade 3 and 4 Clinical and/or
Laboratory Adverse Events (AEs)
Description:
Grade 3 AEs are defined as events that interrupt usual activities of
daily living, or significantly affects clinical status, or may require
intensive therapeutic intervention. Severe events are usually
incapacitating. Grade 4 AEs are defined as events that are potentially
life threatening.
Population Description:
The safety population includes all participants with available data post
baseline, analyzed as treated.
Reporting Status: POSTED
Param Type: NUMBER
Dispersion Type: 95% Confidence Interval
Unit Of Measure: percentage of participants
Time Frame: Day 1 through Day 29
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 516
##### Counts
Group Id: OG001
Value: 532
##### Classes
##### Categories
##### Measurements
Group Id: OG000
Value: 57
Lower Limit: 52.8
Upper Limit: 61.5
##### Measurements
Group Id: OG001
Value: 51
Lower Limit: 47.0
Upper Limit: 55.6
##### Analyses
Non Inferiority Type: SUPERIORITY
P Value: 0.058
Statistical Method: Barnard's Exact Test
Group Ids: OG000, OG001
#### Outcome Measures
Type: SECONDARY
Title: Percentage of Participants Reporting Serious Adverse Events (SAEs)
Description:
An SAE is defined as an AE or suspected adverse reaction is considered
serious if, in the view of either the investigator or the sponsor, it
results in death, a life-threatening AE, inpatient hospitalization or
prolongation of existing hospitalization, a persistent or significant
incapacity or substantial disruption of the ability to conduct normal
life functions, or a congenital anomaly/birth defect.
Population Description:
The safety population includes all participants with available data post
baseline, analyzed as treated.
Reporting Status: POSTED
Param Type: NUMBER
Dispersion Type: 95% Confidence Interval
Unit Of Measure: percentage of participants
Time Frame: Day 1 through Day 29
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 516
##### Counts
Group Id: OG001
Value: 532
##### Classes
##### Categories
##### Measurements
Group Id: OG000
Value: 32
Lower Limit: 27.7
Upper Limit: 35.7
##### Measurements
Group Id: OG001
Value: 24
Lower Limit: 20.9
Upper Limit: 28.3
##### Analyses
Non Inferiority Type: SUPERIORITY
P Value: 0.010
Statistical Method: Barnard's Exact Test
Group Ids: OG000, OG001
#### Outcome Measures
Type: SECONDARY
Title:
Percentage of Participants Discontinued or Temporarily Suspended From
Investigational Therapeutics
Description:
Participants may have been discontinued from investigational
therapeutics due to discharge or death. The halting or slowing of the
infusion for any reason was collected, as was missed doses in the series
of 10 doses.
Population Description:
The intent-to-treat (ITT) population includes all participants who were
randomized
Reporting Status: POSTED
Param Type: NUMBER
Dispersion Type: 95% Confidence Interval
Unit Of Measure: percentage of participants
Time Frame: Day 1 through Day 10
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 521
##### Counts
Group Id: OG001
Value: 541
##### Classes
Title: Discontinued due to discharge
##### Categories
##### Measurements
Group Id: OG000
Value: 30
Lower Limit: 26
Upper Limit: 34
##### Measurements
Group Id: OG001
Value: 41
Lower Limit: 37
Upper Limit: 45
##### Classes
Title: Discontinued due to death
##### Categories
##### Measurements
Group Id: OG000
Value: 4
Lower Limit: 2
Upper Limit: 6
##### Measurements
Group Id: OG001
Value: 3
Lower Limit: 2
Upper Limit: 5
##### Classes
Title: Any infusions halted or slowed
##### Categories
##### Measurements
Group Id: OG000
Value: 2
Lower Limit: 1
Upper Limit: 4
##### Measurements
Group Id: OG001
Value: 2
Lower Limit: 1
Upper Limit: 4
##### Classes
Title: Missed any maintenance dose
##### Categories
##### Measurements
Group Id: OG000
Value: 21
Lower Limit: 18
Upper Limit: 25
##### Measurements
Group Id: OG001
Value: 16
Lower Limit: 13
Upper Limit: 19
#### Outcome Measures
Type: SECONDARY
Title: Duration of Hospitalization
Description:
Duration of hospitalization was determined two ways. The first includes
imputations for participants who died. The second method is restricted
to participants who did not die.
Population Description:
The intent-to-treat (ITT) population includes all participants who were
randomized
Reporting Status: POSTED
Param Type: MEDIAN
Dispersion Type: Inter-Quartile Range
Unit Of Measure: Days
Time Frame: Day 1 through Day 29
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 521
##### Counts
Group Id: OG001
Value: 541
##### Classes
Title: Including imputation for participants who died
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 521
##### Counts
Group Id: OG001
Value: 541
##### Categories
##### Measurements
Group Id: OG000
Value: 17
Lower Limit: 8
Upper Limit: 28
##### Measurements
Group Id: OG001
Value: 12
Lower Limit: 6
Upper Limit: 28
##### Classes
Title: Restricted to participants who did not die
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 443
##### Counts
Group Id: OG001
Value: 480
##### Categories
##### Measurements
Group Id: OG000
Value: 14
Lower Limit: 7
Upper Limit: 27
##### Measurements
Group Id: OG001
Value: 10
Lower Limit: 5
Upper Limit: 21
#### Outcome Measures
Type: SECONDARY
Title: Duration of New Non-invasive Ventilation or High Flow Oxygen Use
Description:
Duration of new non-invasive ventilation or high flow oxygen use was
measured in days among participants who were not on non-invasive
ventilation or high-flow oxygen use at baseline, determined two ways.
The first includes imputations for participants who died. The second
method is restricted to participants who did not die
Population Description:
The analysis population is restricted to randomized participants who
were not on non-invasive ventilation or high-flow oxygen at baseline but
who subsequently required non-invasive or high-flow oxygen.
Reporting Status: POSTED
Param Type: MEDIAN
Dispersion Type: Inter-Quartile Range
Unit Of Measure: Days
Time Frame: Day 1 through Day 29
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 64
##### Counts
Group Id: OG001
Value: 52
##### Classes
Title: Including imputations for participants who died
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 64
##### Counts
Group Id: OG001
Value: 52
##### Categories
##### Measurements
Group Id: OG000
Value: 4
Lower Limit: 2
Upper Limit: 23.5
##### Measurements
Group Id: OG001
Value: 3
Lower Limit: 1
Upper Limit: 10.5
##### Classes
Title: Among participants who did not die
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 50
##### Counts
Group Id: OG001
Value: 43
##### Categories
##### Measurements
Group Id: OG000
Value: 3
Lower Limit: 2
Upper Limit: 6
##### Measurements
Group Id: OG001
Value: 3
Lower Limit: 1
Upper Limit: 6
#### Outcome Measures
Type: SECONDARY
Title: Duration of New Oxygen Use
Description:
Duration of new oxygen use was measured in days among participants who
were not on oxygen at baseline, determined two ways. The first includes
imputations for participants who died. The second method is restricted
to participants who did not die
.
Population Description:
The analysis population is restricted to randomized participants who
were not on oxygen at baseline but who subsequently required oxygen.
Reporting Status: POSTED
Param Type: MEDIAN
Dispersion Type: Inter-Quartile Range
Unit Of Measure: Days
Time Frame: Day 1 through Day 29
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 28
##### Counts
Group Id: OG001
Value: 27
##### Classes
Title: Including imputations for participants who died
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 28
##### Counts
Group Id: OG001
Value: 27
##### Categories
##### Measurements
Group Id: OG000
Value: 5.5
Lower Limit: 1
Upper Limit: 15
##### Measurements
Group Id: OG001
Value: 4
Lower Limit: 2
Upper Limit: 12
##### Classes
Title: Among participants who did not die
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 25
##### Counts
Group Id: OG001
Value: 24
##### Categories
##### Measurements
Group Id: OG000
Value: 3
Lower Limit: 1
Upper Limit: 13
##### Measurements
Group Id: OG001
Value: 3.5
Lower Limit: 2
Upper Limit: 5.5
#### Outcome Measures
Type: SECONDARY
Title:
Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO)
Use
Description:
Duration of new ventilator or ECMO use was measured in days among
participants who were not on a ventilator or ECMO at baseline,
determined two ways. The first includes imputations for participants who
died. The second method is restricted to participants who did not die
Population Description:
The analysis population is restricted to randomized participants not on
a ventilator or ECMO at baseline but who subsequently required a
ventilator or ECMO.
Reporting Status: POSTED
Param Type: MEDIAN
Dispersion Type: Inter-Quartile Range
Unit Of Measure: Days
Time Frame: Day 1 through Day 29
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 82
##### Counts
Group Id: OG001
Value: 52
##### Classes
Title: Including imputations for participants who died
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 82
##### Counts
Group Id: OG001
Value: 52
##### Categories
##### Measurements
Group Id: OG000
Value: 23
Lower Limit: 12
Upper Limit: 28
##### Measurements
Group Id: OG001
Value: 21.5
Lower Limit: 9
Upper Limit: 28
##### Classes
Title: Among participants who did not die
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 57
##### Counts
Group Id: OG001
Value: 39
##### Categories
##### Measurements
Group Id: OG000
Value: 16
Lower Limit: 9
Upper Limit: 24
##### Measurements
Group Id: OG001
Value: 14
Lower Limit: 5
Upper Limit: 26
#### Outcome Measures
Type: SECONDARY
Title:
Percentage of Participants Requiring New Non-invasive Ventilation or
High-flow Oxygen Use
Description:
New non-invasive ventilation or high-flow oxygen use was determined as
the percentage of subject not on non-invasive ventilation or high-flow
oxygen at baseline.
Population Description:
The analysis population is restricted to randomized participants who
were not on non-invasive or high-flow oxygen at baseline.
Reporting Status: POSTED
Param Type: NUMBER
Dispersion Type: 95% Confidence Interval
Unit Of Measure: percentage of participants
Time Frame: Day 1 through Day 29
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 266
##### Counts
Group Id: OG001
Value: 307
##### Classes
##### Categories
##### Measurements
Group Id: OG000
Value: 24
Lower Limit: 19
Upper Limit: 30
##### Measurements
Group Id: OG001
Value: 17
Lower Limit: 13
Upper Limit: 22
#### Outcome Measures
Type: SECONDARY
Title: Percentage of Participants Requiring New Oxygen Use
Description:
The percentage of participants requiring new oxygen use was determined
as the percentage of participants not requiring oxygen at baseline
Population Description:
The analysis population is restricted to randomized participants not
requiring oxygen at baseline.
Reporting Status: POSTED
Param Type: NUMBER
Dispersion Type: 95% Confidence Interval
Unit Of Measure: percentage of participants
Time Frame: Day 1 through Day 29
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 63
##### Counts
Group Id: OG001
Value: 75
##### Classes
##### Categories
##### Measurements
Group Id: OG000
Value: 44
Lower Limit: 33
Upper Limit: 57
##### Measurements
Group Id: OG001
Value: 36
Lower Limit: 26
Upper Limit: 47
#### Outcome Measures
Type: SECONDARY
Title:
Percentage of Participants Requiring New Ventilator or Extracorporeal
Membrane Oxygenation (ECMO) Use
Description:
The percentage of participants requiring new ventilator or ECMO use was
determined as the percentage not on a ventilator or ECMO at baseline
Population Description:
The analysis population is restricted to randomized participants not on
a ventilator or ECMO at baseline.
Reporting Status: POSTED
Param Type: NUMBER
Dispersion Type: 95% Confidence Interval
Unit Of Measure: percentage of participants
Time Frame: Day 1 through Day 29
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 364
##### Counts
Group Id: OG001
Value: 402
##### Classes
##### Categories
##### Measurements
Group Id: OG000
Value: 23
Lower Limit: 19
Upper Limit: 27
##### Measurements
Group Id: OG001
Value: 13
Lower Limit: 10
Upper Limit: 17
#### Outcome Measures
Type: SECONDARY
Title: Mean Change in the Ordinal Scale
Description:
The ordinal scale is an assessment of the clinical status at the first
assessment of a given study day. The scale is as follows: 8) Death; 7)
Hospitalized, on invasive mechanical ventilation or extracorporeal
membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
ventilation or high flow oxygen devices; 5) Hospitalized, requiring
supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
- requiring ongoing medical care (COVID-19 related or otherwise); 3)
Hospitalized, not requiring supplemental oxygen - no longer requires
ongoing medical care; 2) Not hospitalized, limitation on activities
and/or requiring home oxygen; 1) Not hospitalized, no limitations on
activities. A positive change indicates a worsening and a negative
change is an improvement.
Population Description:
The intent-to-treat (ITT) population includes all participants who were
randomized reporting a clinical score. Missing values were imputed using
Last Observation Carried Forward. Clinical scores of 8 were carried
forward from the date of death for participants who died.
Reporting Status: POSTED
Param Type: MEAN
Dispersion Type: Standard Deviation
Unit Of Measure: units on a scale
Time Frame: Day 1, 3, 5, 8, 11, 15, 22, and 29
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 518
##### Counts
Group Id: OG001
Value: 533
##### Classes
Title: Day 3
##### Categories
##### Measurements
Group Id: OG000
Value: 0.2
Spread: 0.6
##### Measurements
Group Id: OG001
Value: 0.1
Spread: 0.6
##### Classes
Title: Day 5
##### Categories
##### Measurements
Group Id: OG000
Value: 0.1
Spread: 0.9
##### Measurements
Group Id: OG001
Value: 0.0
Spread: 0.8
##### Classes
Title: Day 8
##### Categories
##### Measurements
Group Id: OG000
Value: 0.0
Spread: 0.1
##### Measurements
Group Id: OG001
Value: -0.2
Spread: 1.0
##### Classes
Title: Day 11
##### Categories
##### Measurements
Group Id: OG000
Value: -0.1
Spread: 1.3
##### Measurements
Group Id: OG001
Value: -0.3
Spread: 1.1
##### Classes
Title: Day 15
##### Categories
##### Measurements
Group Id: OG000
Value: -1.4
Spread: 2.3
##### Measurements
Group Id: OG001
Value: -1.9
Spread: 2.1
##### Classes
Title: Day 22
##### Categories
##### Measurements
Group Id: OG000
Value: -1.9
Spread: 2.5
##### Measurements
Group Id: OG001
Value: -2.4
Spread: 2.2
##### Classes
Title: Day 29
##### Categories
##### Measurements
Group Id: OG000
Value: -2.3
Spread: 2.6
##### Measurements
Group Id: OG001
Value: -2.7
Spread: 2.3
#### Outcome Measures
Type: SECONDARY
Title: 14-day Participant Mortality
Description:
The mortality rate was determined as the proportion of participants who
died by study Day 15.
Population Description: The ITT population consists of all participants as randomized.
Reporting Status: POSTED
Param Type: NUMBER
Dispersion Type: 95% Confidence Interval
Unit Of Measure: Proportion of participants
Time Frame: Day 1 through Day 15
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 521
##### Counts
Group Id: OG001
Value: 541
##### Classes
##### Categories
##### Measurements
Group Id: OG000
Value: 0.12
Lower Limit: 0.09
Upper Limit: 0.15
##### Measurements
Group Id: OG001
Value: 0.07
Lower Limit: 0.05
Upper Limit: 0.09
#### Outcome Measures
Type: SECONDARY
Title: 29-day Participant Mortality
Description:
The mortality rate was determined as the proportion of participants who
died by study Day 29.
Population Description: The ITT population includes all participants as randomized
Reporting Status: POSTED
Param Type: NUMBER
Dispersion Type: 95% Confidence Interval
Unit Of Measure: Proportion of participants
Time Frame: Day 1 through Day 29
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 521
##### Counts
Group Id: OG001
Value: 541
##### Classes
##### Categories
##### Measurements
Group Id: OG000
Value: 0.15
Lower Limit: 0.12
Upper Limit: 0.19
##### Measurements
Group Id: OG001
Value: 0.11
Lower Limit: 0.09
Upper Limit: 0.15
#### Outcome Measures
Type: SECONDARY
Title: Time to an Improvement by at Least One Category Using an Ordinal Scale
Description:
The ordinal scale is an assessment of the clinical status at the first
assessment of a given study day. The scale is as follows: 8) Death; 7)
Hospitalized, on invasive mechanical ventilation or extracorporeal
membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive
ventilation or high flow oxygen devices; 5) Hospitalized, requiring
supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen
- requiring ongoing medical care (COVID-19 related or otherwise); 3)
Hospitalized, not requiring supplemental oxygen - no longer requires
ongoing medical care; 2) Not hospitalized, limitation on activities
and/or requiring home oxygen; 1) Not hospitalized, no limitations on
activities. Time to improvement by at least one category was determined
for each participant
Population Description: The ITT population includes all participants as randomized
Reporting Status: POSTED
Param Type: MEDIAN
Dispersion Type: 95% Confidence Interval
Unit Of Measure: Days
Time Frame: Day 1 through Day 29
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 521
##### Counts
Group Id: OG001
Value: 541
##### Classes
##### Categories
##### Measurements
Group Id: OG000
Value: 9
Lower Limit: 8
Upper Limit: 11
##### Measurements
Group Id: OG001
Value: 7
Lower Limit: 6
Upper Limit: 8
##### Analyses
Non Inferiority Type: SUPERIORITY
P Value: 0.002
Statistical Method: Log Rank
Param Type: Cox Proportional Hazard
Param Value: 1.23
Ci Pct Value: 95
Ci Num Sides: TWO_SIDED
Ci Lower Limit: 1.08
Ci Upper Limit: 1.41
Group Ids: OG000, OG001
#### Outcome Measures
Type: SECONDARY
Title: Time to an Improvement of at Least Two Categories Using an Ordinal Scale
Description:
The ordinal scale is an assessment of the clinical status at the first
assessment of a given study day. The scale is as follows: 1) Death; 2)
Hospitalized, on invasive mechanical ventilation or extracorporeal
membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive
ventilation or high flow oxygen devices; 4) Hospitalized, requiring
supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen
- requiring ongoing medical care (COVID-19 related or otherwise); 6)
Hospitalized, not requiring supplemental oxygen - no longer requires
ongoing medical care; 7) Not hospitalized, limitation on activities
and/or requiring home oxygen; 8) Not hospitalized, no limitations on
activities. Time to improvement by at least two categories was
determined for each participant
Population Description: The ITT population includes all participants as randomized
Reporting Status: POSTED
Param Type: MEDIAN
Dispersion Type: 95% Confidence Interval
Unit Of Measure: Days
Time Frame: Day 1 through Day 29
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 521
##### Counts
Group Id: OG001
Value: 541
##### Classes
##### Categories
##### Measurements
Group Id: OG000
Value: 14
Lower Limit: 13
Upper Limit: 15
##### Measurements
Group Id: OG001
Value: 11
Lower Limit: 10
Upper Limit: 13
##### Analyses
Non Inferiority Type: SUPERIORITY
P Value: <0.001
Statistical Method: Log Rank
Param Type: Cox Proportional Hazard
Param Value: 1.29
Ci Pct Value: 95
Ci Num Sides: TWO_SIDED
Ci Lower Limit: 1.12
Ci Upper Limit: 1.48
Group Ids: OG000, OG001
#### Outcome Measures
Type: SECONDARY
Title:
Time to Discharge or to a NEWS of 2 or Less and Maintained for 24 Hours,
Whichever Occurs First
Description:
The NEW score has demonstrated an ability to discriminate patients at
risk of poor outcomes. This score is based on 7 clinical parameters
(respiration rate, oxygen saturation, any supplemental oxygen,
temperature, systolic blood pressure, heart rate, level of
consciousness). The NEW Score is being used as an efficacy measure. The
minimum score is 0, representing the better outcome, and the maximum
value is 19, representing the worse outcome. The time to discharge or a
NEWS of less than or equal to 2 was determined for each participant.
Population Description: The ITT population includes all participants as randomized.
Reporting Status: POSTED
Param Type: MEDIAN
Dispersion Type: 95% Confidence Interval
Unit Of Measure: Days
Time Frame: Day 1 through Day 29
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 521
##### Counts
Group Id: OG001
Value: 541
##### Classes
##### Categories
##### Measurements
Group Id: OG000
Value: 12
Lower Limit: 10
Upper Limit: 15
##### Measurements
Group Id: OG001
Value: 8
Lower Limit: 7
Upper Limit: 9
##### Analyses
Non Inferiority Type: SUPERIORITY
P Value: <0.001
Statistical Method: Log Rank
Param Type: Cox Proportional Hazard
Param Value: 1.27
Ci Pct Value: 95
Ci Num Sides: TWO_SIDED
Ci Lower Limit: 1.10
Ci Upper Limit: 1.46
Group Ids: OG000, OG001
#### Outcome Measures
Type: PRIMARY
Title: Time to Recovery by Race
Description:
Day of recovery is defined as the first day on which the subject
satisfies one of the following three categories from the ordinal scale:
1) Hospitalized, not requiring supplemental oxygen - no longer requires
ongoing medical care; 2) Not hospitalized, limitation on activities
and/or requiring home oxygen; 3) Not hospitalized, no limitations on
activities.
Population Description:
The intent-to-treat (ITT) population includes all participants who were
randomized
Reporting Status: POSTED
Param Type: MEDIAN
Dispersion Type: 95% Confidence Interval
Unit Of Measure: Days
Time Frame: Day 1 through Day 29
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 521
##### Counts
Group Id: OG001
Value: 541
##### Classes
Title: Asian
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 56
##### Counts
Group Id: OG001
Value: 79
##### Categories
##### Measurements
Group Id: OG000
Value: 12.0
Lower Limit: 9.0
Upper Limit: 15.0
##### Measurements
Group Id: OG001
Value: 11.0
Lower Limit: 9.0
Upper Limit: 15.0
##### Classes
Title: Black or African American
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 117
##### Counts
Group Id: OG001
Value: 109
##### Categories
##### Measurements
Group Id: OG000
Value: 15.0
Lower Limit: 10.0
Upper Limit: 21.0
##### Measurements
Group Id: OG001
Value: 10.0
Lower Limit: 7.0
Upper Limit: 16.0
##### Classes
Title: White
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 287
##### Counts
Group Id: OG001
Value: 279
##### Categories
##### Measurements
Group Id: OG000
Value: 15.0
Lower Limit: 12.0
Upper Limit: 19.0
##### Measurements
Group Id: OG001
Value: 9.0
Lower Limit: 8.0
Upper Limit: 12.0
##### Classes
Title: Other
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 61
##### Counts
Group Id: OG001
Value: 74
##### Categories
##### Measurements
Group Id: OG000
Value: 24.0
Lower Limit: 15.0
Upper Limit: NA
Comment:
A large number of participants at the median estimate resulted in little
variability at the 50th percentile and the methodology described by
Klein and Moeschberger (1997) was unable to compute an upper confidence
limit.
##### Measurements
Group Id: OG001
Value: 9.0
Lower Limit: 6.0
Upper Limit: 14.0
##### Analyses
Group Description: This analysis is for Asian participants
Non Inferiority Type: SUPERIORITY
Param Type: Cox Proportional Hazard
Param Value: 1.07
Ci Pct Value: 95
Ci Num Sides: TWO_SIDED
Ci Lower Limit: 0.73
Ci Upper Limit: 1.58
Group Ids: OG000, OG001
##### Analyses
Group Description: This analysis is for Black or African American participants
Non Inferiority Type: SUPERIORITY
Param Type: Cox Proportional Hazard
Param Value: 1.25
Ci Pct Value: 95
Ci Num Sides: TWO_SIDED
Ci Lower Limit: 0.91
Ci Upper Limit: 1.72
Group Ids: OG000, OG001
##### Analyses
Group Description: This analysis is for White participants
Non Inferiority Type: SUPERIORITY
Param Type: Cox Proportional Hazard
Param Value: 1.29
Ci Pct Value: 95
Ci Num Sides: TWO_SIDED
Ci Lower Limit: 1.06
Ci Upper Limit: 1.57
Group Ids: OG000, OG001
##### Analyses
Group Description: This analysis is for Race of Other participants
Non Inferiority Type: SUPERIORITY
Param Type: Cox Proportional Hazard
Param Value: 1.68
Ci Pct Value: 95
Ci Num Sides: TWO_SIDED
Ci Lower Limit: 1.10
Ci Upper Limit: 2.58
Group Ids: OG000, OG001
#### Outcome Measures
Type: PRIMARY
Title: Time to Recovery by Ethnicity
Description:
Day of recovery is defined as the first day on which the subject
satisfies one of the following three categories from the ordinal scale:
1) Hospitalized, not requiring supplemental oxygen - no longer requires
ongoing medical care; 2) Not hospitalized, limitation on activities
and/or requiring home oxygen; 3) Not hospitalized, no limitations on
activities.
Population Description:
The intent-to-treat (ITT) population includes all participants who were
randomized and for whom Ethnicity was reported
Reporting Status: POSTED
Param Type: MEDIAN
Dispersion Type: 95% Confidence Interval
Unit Of Measure: Days
Time Frame: Day 1 through Day 29
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 489
##### Counts
Group Id: OG001
Value: 516
##### Classes
Title: Not Hispanic or Latino
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 373
##### Counts
Group Id: OG001
Value: 382
##### Categories
##### Measurements
Group Id: OG000
Value: 15.0
Lower Limit: 13.0
Upper Limit: 18.0
##### Measurements
Group Id: OG001
Value: 10.0
Lower Limit: 8.0
Upper Limit: 12.0
##### Classes
Title: Hispanic or Latino
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 116
##### Counts
Group Id: OG001
Value: 134
##### Categories
##### Measurements
Group Id: OG000
Value: 12.5
Lower Limit: 9.0
Upper Limit: 22.0
##### Measurements
Group Id: OG001
Value: 10.0
Lower Limit: 7.0
Upper Limit: 14.0
##### Analyses
Group Description: This analysis is for Not Hispanic or Latino participants
Non Inferiority Type: SUPERIORITY
Param Type: Cox Proportional Hazard
Param Value: 1.31
Ci Pct Value: 95
Ci Num Sides: TWO_SIDED
Ci Lower Limit: 1.10
Ci Upper Limit: 1.55
Group Ids: OG000, OG001
##### Analyses
Group Description: This analysis is for Hispanic or Latino participants
Non Inferiority Type: SUPERIORITY
Param Type: Cox Proportional Hazard
Param Value: 1.28
Ci Pct Value: 95
Ci Num Sides: TWO_SIDED
Ci Lower Limit: 0.94
Ci Upper Limit: 1.73
Group Ids: OG000, OG001
#### Outcome Measures
Type: PRIMARY
Title: Time to Recovery by Sex
Description:
Day of recovery is defined as the first day on which the subject
satisfies one of the following three categories from the ordinal scale:
1) Hospitalized, not requiring supplemental oxygen - no longer requires
ongoing medical care; 2) Not hospitalized, limitation on activities
and/or requiring home oxygen; 3) Not hospitalized, no limitations on
activities.
Population Description:
The intent-to-treat (ITT) population includes all participants who were
randomized
Reporting Status: POSTED
Param Type: MEDIAN
Dispersion Type: 95% Confidence Interval
Unit Of Measure: Days
Time Frame: Day 1 through Day 29
##### Groups
Id: OG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
##### Groups
Id: OG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 521
##### Counts
Group Id: OG001
Value: 541
##### Classes
Title: Male
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 332
##### Counts
Group Id: OG001
Value: 352
##### Categories
##### Measurements
Group Id: OG000
Value: 15.0
Lower Limit: 12.0
Upper Limit: 19.0
##### Measurements
Group Id: OG001
Value: 9.0
Lower Limit: 8.0
Upper Limit: 12.0
##### Classes
Title: Female
##### Denoms
Units: Participants
##### Counts
Group Id: OG000
Value: 189
##### Counts
Group Id: OG001
Value: 189
##### Categories
##### Measurements
Group Id: OG000
Value: 15.0
Lower Limit: 12.0
Upper Limit: 19.0
##### Measurements
Group Id: OG001
Value: 10.0
Lower Limit: 8.0
Upper Limit: 13.0
##### Analyses
Group Description: This analysis is for Male participants
Non Inferiority Type: SUPERIORITY
Param Type: Cox Proportional Hazard
Param Value: 1.30
Ci Pct Value: 95
Ci Num Sides: TWO_SIDED
Ci Lower Limit: 1.09
Ci Upper Limit: 1.56
Group Ids: OG000, OG001
##### Analyses
Group Description: This analysis is for Female participants
Non Inferiority Type: SUPERIORITY
Param Type: Cox Proportional Hazard
Param Value: 1.31
Ci Pct Value: 95
Ci Num Sides: TWO_SIDED
Ci Lower Limit: 1.03
Ci Upper Limit: 1.66
Group Ids: OG000, OG001
### Adverse Events Module
Frequency Threshold: 5
Time Frame:
Grade 3 and 4 serious and non-serious adverse events were collected for
29 days after the first dose. Laboratory values were systematically
assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient,
and at Days 15 and 29.
Description:
Given the nature of severity of the underlying illness, participants
were expected to have many symptoms and abnormalities in vital signs and
laboratory values. All Grade 3 and 4 AEs were captured as AEs in this
trial. In addition, any Grade 2 or higher, suspected drug-related
hypersensitivity reaction was to be reported as an AE in this trial. All
cause mortality was calculated for the ITT population, while SAEs and
AEs reflect the as treated population.
#### Event Groups
Id: EG000
Title: Placebo
Description:
200 mg of Remdesivir placebo administered intravenously on Day 1,
followed by a 100 mg once-daily maintenance dose of Remdesivir placebo
while hospitalized for up to a 10 days total course.
Deaths Num Affected: 77
Deaths Num At Risk: 521
Serious Num Affected: 163
Serious Num At Risk: 516
Other Num Affected: 295
Other Num At Risk: 516
#### Event Groups
Id: EG001
Title: Remdesivir
Description:
200 mg of Remdesivir administered intravenously on Day 1, followed by a
100 mg once-daily maintenance dose of Remdesivir while hospitalized for
up to a 10 days total course.
Deaths Num Affected: 59
Deaths Num At Risk: 541
Serious Num Affected: 131
Serious Num At Risk: 532
Other Num Affected: 276
Other Num At Risk: 532
#### Serious Events
Term: Coagulopathy
Organ System: Blood and lymphatic system disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Febrile neutropenia
Organ System: Blood and lymphatic system disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Anaemia
Organ System: Blood and lymphatic system disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 1
Num Affected: 1
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 0
Num Affected: 0
Num At Risk: 532
#### Serious Events
Term: Cardiac arrest
Organ System: Cardiac disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 7
Num Affected: 7
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 10
Num Affected: 10
Num At Risk: 532
#### Serious Events
Term: Atrial fibrillation
Organ System: Cardiac disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 2
Num Affected: 1
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 6
Num Affected: 5
Num At Risk: 532
#### Serious Events
Term: Cardio-respiratory arrest
Organ System: Cardiac disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 3
Num Affected: 3
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Myocardial infarction
Organ System: Cardiac disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 4
Num Affected: 4
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 0
Num Affected: 0
Num At Risk: 532
#### Serious Events
Term: Supraventricular tachycardia
Organ System: Cardiac disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 3
Num Affected: 3
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 0
Num Affected: 0
Num At Risk: 532
#### Serious Events
Term: Ventricular tachycardia
Organ System: Cardiac disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 2
Num Affected: 2
Num At Risk: 532
#### Serious Events
Term: Acute myocardial infarction
Organ System: Cardiac disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 1
Num Affected: 1
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Cardiac failure
Organ System: Cardiac disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 1
Num Affected: 1
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Cardiogenic shock
Organ System: Cardiac disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 2
Num Affected: 2
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 0
Num Affected: 0
Num At Risk: 532
#### Serious Events
Term: Acute coronary syndrome
Organ System: Cardiac disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Arrhythmia
Organ System: Cardiac disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Palpitations
Organ System: Cardiac disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Pulseless electrical activity
Organ System: Cardiac disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Ventricular fibrillation
Organ System: Cardiac disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Cardiac tamponade
Organ System: Cardiac disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 1
Num Affected: 1
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 0
Num Affected: 0
Num At Risk: 532
#### Serious Events
Term: Intestinal ischaemia
Organ System: Gastrointestinal disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 3
Num Affected: 3
Num At Risk: 532
#### Serious Events
Term: Diarrhoea
Organ System: Gastrointestinal disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Duodenal perforation
Organ System: Gastrointestinal disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Gastrointestinal haemorrhage
Organ System: Gastrointestinal disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Small intestinal perforation
Organ System: Gastrointestinal disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Haematemesis
Organ System: Gastrointestinal disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 1
Num Affected: 1
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 0
Num Affected: 0
Num At Risk: 532
#### Serious Events
Term: Peptic ulcer haemorrhage
Organ System: Gastrointestinal disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 1
Num Affected: 1
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 0
Num Affected: 0
Num At Risk: 532
#### Serious Events
Term: Small intestinal obstruction
Organ System: Gastrointestinal disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 1
Num Affected: 1
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 0
Num Affected: 0
Num At Risk: 532
#### Serious Events
Term: Multiple organ dysfunction syndrome
Organ System: General disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 3
Num Affected: 3
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 5
Num Affected: 5
Num At Risk: 532
#### Serious Events
Term: Pyrexia
Organ System: General disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 2
Num Affected: 2
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Chest pain
Organ System: General disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Death
Organ System: General disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 1
Num Affected: 1
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 0
Num Affected: 0
Num At Risk: 532
#### Serious Events
Term: Hepatitis
Organ System: Hepatobiliary disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 1
Num Affected: 1
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 0
Num Affected: 0
Num At Risk: 532
#### Serious Events
Term: Ischaemic hepatitis
Organ System: Hepatobiliary disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 1
Num Affected: 1
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 0
Num Affected: 0
Num At Risk: 532
#### Serious Events
Term: Drug hypersensitivity
Organ System: Immune system disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 1
Num Affected: 1
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 0
Num Affected: 0
Num At Risk: 532
#### Serious Events
Term: Septic shock
Organ System: Infections and infestations
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 15
Num Affected: 15
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 8
Num Affected: 8
Num At Risk: 532
#### Serious Events
Term: COVID-19
Organ System: Infections and infestations
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 5
Num Affected: 5
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 2
Num Affected: 2
Num At Risk: 532
#### Serious Events
Term: Bacteraemia
Organ System: Infections and infestations
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 2
Num Affected: 2
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: COVID-19 pneumonia
Organ System: Infections and infestations
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 2
Num Affected: 2
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Sepsis
Organ System: Infections and infestations
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 2
Num Affected: 2
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Pneumonia
Organ System: Infections and infestations
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 2
Num Affected: 2
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 0
Num Affected: 0
Num At Risk: 532
#### Serious Events
Term: Catheter bacteraemia
Organ System: Infections and infestations
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Gangrene
Organ System: Infections and infestations
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Infectious pleural effusion
Organ System: Infections and infestations
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Staphylococcal bacteraemia
Organ System: Infections and infestations
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Urinary tract infection
Organ System: Infections and infestations
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Bacterial sepsis
Organ System: Infections and infestations
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 1
Num Affected: 1
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 0
Num Affected: 0
Num At Risk: 532
#### Serious Events
Term: Endocarditis bacterial
Organ System: Infections and infestations
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 1
Num Affected: 1
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 0
Num Affected: 0
Num At Risk: 532
#### Serious Events
Term: Hip fracture
Organ System: Injury, poisoning and procedural complications
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Infusion related reaction
Organ System: Injury, poisoning and procedural complications
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Procedural pneumothorax
Organ System: Injury, poisoning and procedural complications
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 1
Num Affected: 1
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 0
Num Affected: 0
Num At Risk: 532
#### Serious Events
Term: Glomerular filtration rate decreased
Organ System: Investigations
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 3
Num Affected: 2
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 5
Num Affected: 5
Num At Risk: 532
#### Serious Events
Term: Haemoglobin decreased
Organ System: Investigations
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 2
Num Affected: 2
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Oxygen saturation decreased
Organ System: Investigations
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 1
Num Affected: 1
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Blood creatinine increased
Organ System: Investigations
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Lymphocyte count decreased
Organ System: Investigations
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Acidosis
Organ System: Metabolism and nutrition disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 1
Num Affected: 1
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Dehydration
Organ System: Metabolism and nutrition disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Hypernatraemia
Organ System: Metabolism and nutrition disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Hyponatraemia
Organ System: Metabolism and nutrition disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Decreased appetite
Organ System: Metabolism and nutrition disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 1
Num Affected: 1
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 0
Num Affected: 0
Num At Risk: 532
#### Serious Events
Term: Pain in extremity
Organ System: Musculoskeletal and connective tissue disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Myalgia
Organ System: Musculoskeletal and connective tissue disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 1
Num Affected: 1
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 0
Num Affected: 0
Num At Risk: 532
#### Serious Events
Term: Myopathy
Organ System: Musculoskeletal and connective tissue disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 1
Num Affected: 1
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 0
Num Affected: 0
Num At Risk: 532
#### Serious Events
Term: Cerebrovascular accident
Organ System: Nervous system disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 1
Num Affected: 1
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 3
Num Affected: 3
Num At Risk: 532
#### Serious Events
Term: Seizure
Organ System: Nervous system disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 1
Num Affected: 1
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 2
Num Affected: 2
Num At Risk: 532
#### Serious Events
Term: Cerebellar infarction
Organ System: Nervous system disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Cerebral haemorrhage
Organ System: Nervous system disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Encephalopathy
Organ System: Nervous system disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Subarachnoid haemorrhage
Organ System: Nervous system disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Depressed level of consciousness
Organ System: Nervous system disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 1
Num Affected: 1
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 0
Num Affected: 0
Num At Risk: 532
#### Serious Events
Term: Haemorrhagic transformation stroke
Organ System: Nervous system disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 1
Num Affected: 1
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 0
Num Affected: 0
Num At Risk: 532
#### Serious Events
Term: Hemiparesis
Organ System: Nervous system disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 1
Num Affected: 1
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 0
Num Affected: 0
Num At Risk: 532
#### Serious Events
Term: Intensive care unit acquired weakness
Organ System: Nervous system disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 1
Num Affected: 1
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 0
Num Affected: 0
Num At Risk: 532
#### Serious Events
Term: Ischaemic stroke
Organ System: Nervous system disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 1
Num Affected: 1
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 0
Num Affected: 0
Num At Risk: 532
#### Serious Events
Term: Mental status changes
Organ System: Psychiatric disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Psychotic disorder
Organ System: Psychiatric disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 1
Num Affected: 1
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 0
Num Affected: 0
Num At Risk: 532
#### Serious Events
Term: Acute kidney injury
Organ System: Renal and urinary disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 12
Num Affected: 12
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 7
Num Affected: 7
Num At Risk: 532
#### Serious Events
Term: Renal failure
Organ System: Renal and urinary disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 5
Num Affected: 5
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 2
Num Affected: 2
Num At Risk: 532
#### Serious Events
Term: Renal impairment
Organ System: Renal and urinary disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 3
Num Affected: 3
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Respiratory failure
Organ System: Respiratory, thoracic and mediastinal disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 59
Num Affected: 58
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 36
Num Affected: 35
Num At Risk: 532
#### Serious Events
Term: Acute respiratory failure
Organ System: Respiratory, thoracic and mediastinal disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 14
Num Affected: 14
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 8
Num Affected: 8
Num At Risk: 532
#### Serious Events
Term: Respiratory distress
Organ System: Respiratory, thoracic and mediastinal disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 11
Num Affected: 11
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 6
Num Affected: 6
Num At Risk: 532
#### Serious Events
Term: Acute respiratory distress syndrome
Organ System: Respiratory, thoracic and mediastinal disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 5
Num Affected: 5
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 7
Num Affected: 7
Num At Risk: 532
#### Serious Events
Term: Pneumothorax
Organ System: Respiratory, thoracic and mediastinal disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 5
Num Affected: 5
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 5
Num Affected: 5
Num At Risk: 532
#### Serious Events
Term: Pulmonary embolism
Organ System: Respiratory, thoracic and mediastinal disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 4
Num Affected: 4
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 5
Num Affected: 5
Num At Risk: 532
#### Serious Events
Term: Hypoxia
Organ System: Respiratory, thoracic and mediastinal disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 4
Num Affected: 4
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 4
Num Affected: 4
Num At Risk: 532
#### Serious Events
Term: Pneumonia aspiration
Organ System: Respiratory, thoracic and mediastinal disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 2
Num Affected: 2
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 4
Num Affected: 4
Num At Risk: 532
#### Serious Events
Term: Dyspnoea
Organ System: Respiratory, thoracic and mediastinal disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 1
Num Affected: 1
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 3
Num Affected: 3
Num At Risk: 532
#### Serious Events
Term: Respiratory disorder
Organ System: Respiratory, thoracic and mediastinal disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 2
Num Affected: 2
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 0
Num Affected: 0
Num At Risk: 532
#### Serious Events
Term: Chronic respiratory failure
Organ System: Respiratory, thoracic and mediastinal disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Haemoptysis
Organ System: Respiratory, thoracic and mediastinal disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Pulmonary haemorrhage
Organ System: Respiratory, thoracic and mediastinal disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Subcutaneous emphysema
Organ System: Skin and subcutaneous tissue disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Endotracheal intubation
Organ System: Surgical and medical procedures
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 9
Num Affected: 9
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 6
Num Affected: 6
Num At Risk: 532
#### Serious Events
Term: Mechanical ventilation
Organ System: Surgical and medical procedures
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 3
Num Affected: 3
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Hypotension
Organ System: Vascular disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 7
Num Affected: 7
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 4
Num Affected: 4
Num At Risk: 532
#### Serious Events
Term: Shock
Organ System: Vascular disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 4
Num Affected: 4
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 5
Num Affected: 5
Num At Risk: 532
#### Serious Events
Term: Deep vein thrombosis
Organ System: Vascular disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 1
Num Affected: 1
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Embolism venous
Organ System: Vascular disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Peripheral artery occlusion
Organ System: Vascular disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Serious Events
Term: Shock haemorrhagic
Organ System: Vascular disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 0
Num Affected: 0
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 1
Num Affected: 1
Num At Risk: 532
#### Other Events
Term: Glomerular filtration rate decreased
Organ System: Investigations
Source Vocabulary: MedDRA (23.0)
Assessment Type: SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 81
Num Affected: 74
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 59
Num Affected: 55
Num At Risk: 532
#### Other Events
Term: Haemoglobin decreased
Organ System: Investigations
Source Vocabulary: MedDRA (23.0)
Assessment Type: SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 69
Num Affected: 62
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 51
Num Affected: 48
Num At Risk: 532
#### Other Events
Term: Lymphocyte count decreased
Organ System: Investigations
Source Vocabulary: MedDRA (23.0)
Assessment Type: SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 63
Num Affected: 54
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 56
Num Affected: 44
Num At Risk: 532
#### Other Events
Term: Anaemia
Organ System: Blood and lymphatic system disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 58
Num Affected: 52
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 52
Num Affected: 42
Num At Risk: 532
#### Other Events
Term: Pyrexia
Organ System: General disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 37
Num Affected: 32
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 52
Num Affected: 38
Num At Risk: 532
#### Other Events
Term: Hyperglycaemia
Organ System: Metabolism and nutrition disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 43
Num Affected: 34
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 36
Num Affected: 34
Num At Risk: 532
#### Other Events
Term: Blood creatinine increased
Organ System: Investigations
Source Vocabulary: MedDRA (23.0)
Assessment Type: SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 41
Num Affected: 36
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 33
Num Affected: 31
Num At Risk: 532
#### Other Events
Term: Blood glucose increased
Organ System: Investigations
Source Vocabulary: MedDRA (23.0)
Assessment Type: SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 31
Num Affected: 27
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 45
Num Affected: 39
Num At Risk: 532
#### Other Events
Term: Aspartate aminotransferase increased
Organ System: Investigations
Source Vocabulary: MedDRA (23.0)
Assessment Type: SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 35
Num Affected: 33
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 19
Num Affected: 18
Num At Risk: 532
#### Other Events
Term: Lymphopenia
Organ System: Blood and lymphatic system disorders
Source Vocabulary: MedDRA (23.0)
Assessment Type: SYSTEMATIC_ASSESSMENT
##### Stats
Group Id: EG000
Num Events: 34
Num Affected: 30
Num At Risk: 516
##### Stats
Group Id: EG001
Num Events: 15
Num Affected: 13
Num At Risk: 532
### More Info Module
#### Certain Agreement
Pi Sponsor Employee: False
Restriction Type: LTE60
Restrictive Agreement: True
#### Point Of Contact
Title: John Beigel, MD
Organization: Organization:NIAID
Email: [email protected]
Phone: 3014519881
## Document Section
### Large Document Module
#### Large Docs
Type Abbrev: Prot
Has Protocol: True
Has Sap: False
Has Icf: False
Label: Study Protocol
Date: 2020-04-02
Upload Date: 2020-09-16T16:07
Filename: Prot_001.pdf
Size: 846604
#### Large Docs
Type Abbrev: SAP
Has Protocol: False
Has Sap: True
Has Icf: False
Label: Statistical Analysis Plan
Date: 2020-05-29
Upload Date: 2020-09-16T16:08
Filename: SAP_002.pdf
Size: 2793155
#### Large Docs
Type Abbrev: ICF
Has Protocol: False
Has Sap: False
Has Icf: True
Label: Informed Consent Form
Date: 2020-03-04
Upload Date: 2020-07-20T15:36
Filename: ICF_000.pdf
Size: 281581
## Derived Section
### Misc Info Module
Version Holder: 2025-03-21
### Condition Browse Module
#### Meshes
Id: D000086382
Term: COVID-19
#### Ancestors
Id: D011024
Term: Pneumonia, Viral
#### Ancestors
Id: D011014
Term: Pneumonia
#### Ancestors
Id: D012141
Term: Respiratory Tract Infections
#### Ancestors
Id: D007239
Term: Infections
#### Ancestors
Id: D014777
Term: Virus Diseases
#### Ancestors
Id: D018352
Term: Coronavirus Infections
#### Ancestors
Id: D003333
Term: Coronaviridae Infections
#### Ancestors
Id: D030341
Term: Nidovirales Infections
#### Ancestors
Id: D012327
Term: RNA Virus Infections
#### Ancestors
Id: D008171
Term: Lung Diseases
#### Ancestors
Id: D012140
Term: Respiratory Tract Diseases
#### Browse Leaves
Id: M2561
Name: COVID-19
As Found: COVID-19
Relevance: HIGH
#### Browse Leaves
Id: M20490
Name: Coronavirus Infections
Relevance: LOW
#### Browse Leaves
Id: M13904
Name: Pneumonia
Relevance: LOW
#### Browse Leaves
Id: M13914
Name: Pneumonia, Viral
Relevance: LOW
#### Browse Leaves
Id: M10283
Name: Infections
Relevance: LOW
#### Browse Leaves
Id: M6368
Name: Communicable Diseases
Relevance: LOW
#### Browse Leaves
Id: M14978
Name: Respiratory Tract Infections
Relevance: LOW
#### Browse Leaves
Id: M17522
Name: Virus Diseases
Relevance: LOW
#### Browse Leaves
Id: M6555
Name: Coronaviridae Infections
Relevance: LOW
#### Browse Leaves
Id: M23685
Name: Nidovirales Infections
Relevance: LOW
#### Browse Leaves
Id: M15149
Name: RNA Virus Infections
Relevance: LOW
#### Browse Leaves
Id: M11168
Name: Lung Diseases
Relevance: LOW
#### Browse Leaves
Id: M14977
Name: Respiratory Tract Diseases
Relevance: LOW
#### Browse Branches
Abbrev: BC01
Name: Infections
#### Browse Branches
Abbrev: BC08
Name: Respiratory Tract (Lung and Bronchial) Diseases
#### Browse Branches
Abbrev: All
Name: All Conditions
#### Browse Branches
Abbrev: BC23
Name: Symptoms and General Pathology
### Intervention Browse Module
#### Meshes
Id: C000606551
Term: Remdesivir
#### Ancestors
Id: D000963
Term: Antimetabolites
#### Ancestors
Id: D045504
Term: Molecular Mechanisms of Pharmacological Action
#### Ancestors
Id: D000998
Term: Antiviral Agents
#### Ancestors
Id: D000890
Term: Anti-Infective Agents
#### Browse Leaves
Id: M6263
Name: Coal Tar
Relevance: LOW
#### Browse Leaves
Id: M341627
Name: Remdesivir
As Found: Isoniazid
Relevance: HIGH
#### Browse Leaves
Id: M341633
Name: GS-441524
Relevance: LOW
#### Browse Leaves
Id: M107438
Name: Betadex
Relevance: LOW
#### Browse Leaves
Id: M4281
Name: Antimetabolites
Relevance: LOW
#### Browse Leaves
Id: M4314
Name: Antiviral Agents
Relevance: LOW
#### Browse Leaves
Id: M4214
Name: Anti-Infective Agents
Relevance: LOW
#### Browse Branches
Abbrev: Derm
Name: Dermatologic Agents
#### Browse Branches
Abbrev: All
Name: All Drugs and Chemicals
#### Browse Branches
Abbrev: Infe
Name: Anti-Infective Agents
```