This is page 15 of 15. Use http://codebase.md/genomoncology/biomcp?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.json:
--------------------------------------------------------------------------------
```json
{
"studies": [
{
"protocolSection": {
"identificationModule": {
"nctId": "NCT04280705",
"orgStudyIdInfo": {
"id": "20-0006"
},
"organization": {
"fullName": "National Institute of Allergy and Infectious Diseases (NIAID)",
"class": "NIH"
},
"briefTitle": "Adaptive COVID-19 Treatment Trial (ACTT)",
"officialTitle": "A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults"
},
"statusModule": {
"statusVerifiedDate": "2020-04",
"overallStatus": "COMPLETED",
"expandedAccessInfo": {
"hasExpandedAccess": false
},
"startDateStruct": {
"date": "2020-02-21",
"type": "ACTUAL"
},
"primaryCompletionDateStruct": {
"date": "2020-05-21",
"type": "ACTUAL"
},
"completionDateStruct": {
"date": "2020-05-21",
"type": "ACTUAL"
},
"studyFirstSubmitDate": "2020-02-20",
"studyFirstSubmitQcDate": "2020-02-20",
"studyFirstPostDateStruct": {
"date": "2020-02-21",
"type": "ACTUAL"
},
"resultsFirstSubmitDate": "2020-09-16",
"resultsFirstSubmitQcDate": "2020-09-22",
"resultsFirstPostDateStruct": {
"date": "2020-09-25",
"type": "ACTUAL"
},
"lastUpdateSubmitDate": "2022-03-09",
"lastUpdatePostDateStruct": {
"date": "2022-03-14",
"type": "ACTUAL"
}
},
"sponsorCollaboratorsModule": {
"responsibleParty": {
"type": "SPONSOR"
},
"leadSponsor": {
"name": "National Institute of Allergy and Infectious Diseases (NIAID)",
"class": "NIH"
}
},
"oversightModule": {
"isFdaRegulatedDrug": true,
"isFdaRegulatedDevice": false,
"isUsExport": false
},
"descriptionModule": {
"briefSummary": "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.",
"detailedDescription": "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.\n\nThe 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.\n\nSubjects 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.\n\nAll 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).\n\nThe 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.\n\nContacts:\n\n20-0006 Central Contact\n\nTelephone: 1 (301) 7617948\n\nEmail: [email protected]"
},
"conditionsModule": {
"conditions": ["COVID-19"],
"keywords": [
"Adaptive",
"COVID-19",
"Efficacy",
"Multicenter",
"novel coronavirus",
"Safety",
"ACTT"
]
},
"designModule": {
"studyType": "INTERVENTIONAL",
"phases": ["PHASE3"],
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"primaryPurpose": "TREATMENT",
"maskingInfo": {
"masking": "DOUBLE",
"whoMasked": ["PARTICIPANT", "INVESTIGATOR"]
}
},
"enrollmentInfo": {
"count": 1062,
"type": "ACTUAL"
}
},
"armsInterventionsModule": {
"armGroups": [
{
"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.",
"interventionNames": ["Other: Placebo"]
},
{
"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.",
"interventionNames": ["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.",
"armGroupLabels": ["Placebo"]
},
{
"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.",
"armGroupLabels": ["Remdesivir"]
}
]
},
"outcomesModule": {
"primaryOutcomes": [
{
"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.",
"timeFrame": "Day 1 through Day 29"
},
{
"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.",
"timeFrame": "Day 1 through Day 29"
},
{
"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.",
"timeFrame": "Day 1 through Day 29"
},
{
"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.",
"timeFrame": "Day 1 through Day 29"
}
],
"secondaryOutcomes": [
{
"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.",
"timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29"
},
{
"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.",
"timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29"
},
{
"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.",
"timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29"
},
{
"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.",
"timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29"
},
{
"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.",
"timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29"
},
{
"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.",
"timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29"
},
{
"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.",
"timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29"
},
{
"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.",
"timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29"
},
{
"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.",
"timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29"
},
{
"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.",
"timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29"
},
{
"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.",
"timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29"
},
{
"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.",
"timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29"
},
{
"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.",
"timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29"
},
{
"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.",
"timeFrame": "Days 1, 3, 5, 8, 11, 15 and 29"
},
{
"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.",
"timeFrame": "Days 1, 3, 5, 8, 11, 15, 22, and 29"
},
{
"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.",
"timeFrame": "Day 1"
},
{
"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.",
"timeFrame": "Day 3"
},
{
"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.",
"timeFrame": "Day 5"
},
{
"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.",
"timeFrame": "Day 8"
},
{
"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.",
"timeFrame": "Day 11"
},
{
"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.",
"timeFrame": "Day 15"
},
{
"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.",
"timeFrame": "Day 22"
},
{
"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.",
"timeFrame": "Day 29"
},
{
"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.",
"timeFrame": "Day 1 through Day 29"
},
{
"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.",
"timeFrame": "Day 1 through Day 29"
},
{
"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.",
"timeFrame": "Day 1 through Day 10"
},
{
"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.",
"timeFrame": "Day 1 through Day 29"
},
{
"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",
"timeFrame": "Day 1 through Day 29"
},
{
"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\n\n.",
"timeFrame": "Day 1 through Day 29"
},
{
"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",
"timeFrame": "Day 1 through Day 29"
},
{
"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.",
"timeFrame": "Day 1 through Day 29"
},
{
"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",
"timeFrame": "Day 1 through Day 29"
},
{
"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",
"timeFrame": "Day 1 through Day 29"
},
{
"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.",
"timeFrame": "Day 1, 3, 5, 8, 11, 15, 22, and 29"
},
{
"measure": "14-day Participant Mortality",
"description": "The mortality rate was determined as the proportion of participants who died by study Day 15.",
"timeFrame": "Day 1 through Day 15"
},
{
"measure": "29-day Participant Mortality",
"description": "The mortality rate was determined as the proportion of participants who died by study Day 29.",
"timeFrame": "Day 1 through Day 29"
},
{
"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",
"timeFrame": "Day 1 through Day 29"
},
{
"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",
"timeFrame": "Day 1 through Day 29"
},
{
"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.",
"timeFrame": "Day 1 through Day 29"
}
]
},
"eligibilityModule": {
"eligibilityCriteria": "Inclusion Criteria:\n\n1. Admitted to a hospital with symptoms suggestive of COVID-19 infection.\n2. Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures.\n3. Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.\n4. Male or non-pregnant female adult \\> / = 18 years of age at time of enrollment.\n5. 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:\n\n 1. PCR positive in sample collected \\< 72 hours prior to randomization; OR\n\n Exclusion Criteria:\n 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.\n6. Illness of any duration, and at least one of the following:\n\n 1. Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR\n 2. SpO2 \\< / = 94% on room air, OR\n 3. Requiring supplemental oxygen, OR\n 4. Requiring mechanical ventilation.\n7. 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.\n8. Agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 through Day 29.\n\nExclusion Criteria:\n\n1. Alanine Transaminase (ALT) or Aspartate Transaminase (AST) \\> 5 times the upper limit of normal.\n2. Estimated glomerular filtration rate (eGFR) \\< 30 ml/min (including patients receiving hemodialysis or hemofiltration).\n3. Pregnancy or breast feeding.\n4. Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours.\n5. Allergy to any study medication.",
"healthyVolunteers": false,
"sex": "ALL",
"minimumAge": "18 Years",
"maximumAge": "99 Years",
"stdAges": ["ADULT", "OLDER_ADULT"]
},
"contactsLocationsModule": {
"locations": [
{
"facility": "University of Alabama at Birmingham School of Medicine - Infectious Disease",
"city": "Birmingham",
"state": "Alabama",
"zip": "35233",
"country": "United States",
"geoPoint": {
"lat": 33.52066,
"lon": -86.80249
}
},
{
"facility": "University of California San Diego Health - Jacobs Medical Center",
"city": "La Jolla",
"state": "California",
"zip": "29037",
"country": "United States",
"geoPoint": {
"lat": 32.84727,
"lon": -117.2742
}
},
{
"facility": "University of California Los Angeles Medical Center - Westwood Clinic",
"city": "Los Angeles",
"state": "California",
"zip": "90095",
"country": "United States",
"geoPoint": {
"lat": 34.05223,
"lon": -118.24368
}
},
{
"facility": "University of California Irvine Medical Center - Infectious Disease",
"city": "Orange",
"state": "California",
"zip": "92868-3298",
"country": "United States",
"geoPoint": {
"lat": 33.78779,
"lon": -117.85311
}
},
{
"facility": "VA Palo Alto Health Care System - Infectious Diseases",
"city": "Palo Alto",
"state": "California",
"zip": "94304-1207",
"country": "United States",
"geoPoint": {
"lat": 37.44188,
"lon": -122.14302
}
},
{
"facility": "University of California Davis Medical Center - Internal Medicine - Infectious Disease",
"city": "Sacramento",
"state": "California",
"zip": "95817-1460",
"country": "United States",
"geoPoint": {
"lat": 38.58157,
"lon": -121.4944
}
},
{
"facility": "Naval Medical Center San Diego - Infectious Disease Clinic",
"city": "San Diego",
"state": "California",
"zip": "92314",
"country": "United States",
"geoPoint": {
"lat": 32.71533,
"lon": -117.15726
}
},
{
"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",
"geoPoint": {
"lat": 37.77493,
"lon": -122.41942
}
},
{
"facility": "Stanford University - Stanford Hospital and Clinics - Pediatrics - Infectious Diseases",
"city": "Stanford",
"state": "California",
"zip": "94305-2200",
"country": "United States",
"geoPoint": {
"lat": 37.42411,
"lon": -122.16608
}
},
{
"facility": "Cedars Sinai Medical Center",
"city": "West Hollywood",
"state": "California",
"zip": "90048-1804",
"country": "United States",
"geoPoint": {
"lat": 34.09001,
"lon": -118.36174
}
},
{
"facility": "Denver Health Division of Hospital Medicine - Main Campus",
"city": "Denver",
"state": "Colorado",
"zip": "80204",
"country": "United States",
"geoPoint": {
"lat": 39.73915,
"lon": -104.9847
}
},
{
"facility": "Emory Vaccine Center - The Hope Clinic",
"city": "Decatur",
"state": "Georgia",
"zip": "30030-1705",
"country": "United States",
"geoPoint": {
"lat": 33.77483,
"lon": -84.29631
}
},
{
"facility": "Northwestern Hospital - Infectious Disease",
"city": "Chicago",
"state": "Illinois",
"zip": "60611-2908",
"country": "United States",
"geoPoint": {
"lat": 41.85003,
"lon": -87.65005
}
},
{
"facility": "University of Illinois at Chicago College of Medicine - Division of Infectious Diseases",
"city": "Chicago",
"state": "Illinois",
"zip": "60612",
"country": "United States",
"geoPoint": {
"lat": 41.85003,
"lon": -87.65005
}
},
{
"facility": "Southeast Louisiana Veterans Health Care System - Section of Infectious Diseases",
"city": "New Orleans",
"state": "Louisiana",
"zip": "70119",
"country": "United States",
"geoPoint": {
"lat": 29.95465,
"lon": -90.07507
}
},
{
"facility": "University of Maryland School of Medicine - Center for Vaccine Development - Baltimore",
"city": "Baltimore",
"state": "Maryland",
"zip": "21201-1509",
"country": "United States",
"geoPoint": {
"lat": 39.29038,
"lon": -76.61219
}
},
{
"facility": "Johns Hopkins Hospital - Medicine - Infectious Diseases",
"city": "Baltimore",
"state": "Maryland",
"zip": "21287-0005",
"country": "United States",
"geoPoint": {
"lat": 39.29038,
"lon": -76.61219
}
},
{
"facility": "Walter Reed National Military Medical Center",
"city": "Bethesda",
"state": "Maryland",
"zip": "20889",
"country": "United States",
"geoPoint": {
"lat": 38.98067,
"lon": -77.10026
}
},
{
"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",
"geoPoint": {
"lat": 38.98067,
"lon": -77.10026
}
},
{
"facility": "Massachusetts General Hospital - Infectious Diseases",
"city": "Boston",
"state": "Massachusetts",
"zip": "02114-2621",
"country": "United States",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
}
},
{
"facility": "University of Massachusetts Medical School - Infectious Diseases and Immunology",
"city": "Worcester",
"state": "Massachusetts",
"zip": "01655-0002",
"country": "United States",
"geoPoint": {
"lat": 42.26259,
"lon": -71.80229
}
},
{
"facility": "University of Minnesota Medical Center, Fairview - Infectious Diseases and International Medicine",
"city": "Minneapolis",
"state": "Minnesota",
"zip": "55455-0341",
"country": "United States",
"geoPoint": {
"lat": 44.97997,
"lon": -93.26384
}
},
{
"facility": "Saint Louis University - Center for Vaccine Development",
"city": "Saint Louis",
"state": "Missouri",
"zip": "63104-1015",
"country": "United States",
"geoPoint": {
"lat": 38.62727,
"lon": -90.19789
}
},
{
"facility": "University of Nebraska Medical Center - Infectious Diseases",
"city": "Omaha",
"state": "Nebraska",
"zip": "68105",
"country": "United States",
"geoPoint": {
"lat": 41.25626,
"lon": -95.94043
}
},
{
"facility": "Montefiore Medical Center - Infectious Diseases",
"city": "Bronx",
"state": "New York",
"zip": "10467-2401",
"country": "United States",
"geoPoint": {
"lat": 40.84985,
"lon": -73.86641
}
},
{
"facility": "New York University School of Medicine - Langone Medical Center - Microbiology - Parasitology",
"city": "New York",
"state": "New York",
"zip": "10016-6402",
"country": "United States",
"geoPoint": {
"lat": 40.71427,
"lon": -74.00597
}
},
{
"facility": "University of Rochester Medical Center - Vaccine Research Unit",
"city": "Rochester",
"state": "New York",
"zip": "14642-0001",
"country": "United States",
"geoPoint": {
"lat": 43.15478,
"lon": -77.61556
}
},
{
"facility": "Duke Human Vaccine Institute - Duke Vaccine and Trials Unit",
"city": "Durham",
"state": "North Carolina",
"zip": "27704",
"country": "United States",
"geoPoint": {
"lat": 35.99403,
"lon": -78.89862
}
},
{
"facility": "Penn State Health Milton S. Hershey Medical Center - Division of Infectious Diseases",
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},
{
"facility": "National Center for Global Health and Medicine Hospital - Disease Control and Prevention Center",
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},
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},
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},
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},
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},
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"facility": "Hospital Germans Trias i Pujol - Servei Malalties Infeccioses",
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},
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"facility": "Royal Sussex County Hospital - Department of Intensive Care Medicine",
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"zip": "BN2 5BE",
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},
{
"facility": "Saint Thomas' Hospital - Directorate of Infection",
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"state": "London, City Of",
"zip": "SE1 7EH",
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"geoPoint": {
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},
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"zip": "NE1 4LP",
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},
{
"facility": "St. James's University Hospital - Infectious Diseases",
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"state": "West Yorkshire",
"zip": "LS9 7TK",
"country": "United Kingdom",
"geoPoint": {
"lat": 53.79648,
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},
{
"facility": "John Radcliffe Hospital",
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"zip": "OX3 9DU",
"country": "United Kingdom"
}
]
},
"referencesModule": {
"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."
},
{
"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."
},
{
"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."
},
{
"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."
},
{
"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."
}
]
}
},
"resultsSection": {
"participantFlowModule": {
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"groups": [
{
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"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.\n\nPlacebo: 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."
},
{
"id": "FG001",
"title": "Remdesivir",
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}
],
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},
{
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}
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},
{
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{
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},
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}
],
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},
{
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},
{
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},
{
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},
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},
{
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},
{
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]
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},
"baselineCharacteristicsModule": {
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},
{
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},
{
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}
],
"denoms": [
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"counts": [
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},
{
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"value": "541"
},
{
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}
]
}
],
"measures": [
{
"title": "Age, Categorical",
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"unitOfMeasure": "Participants",
"classes": [
{
"categories": [
{
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"measurements": [
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},
{
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"value": "0"
},
{
"groupId": "BG002",
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},
{
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},
{
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},
{
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}
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},
{
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},
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},
{
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}
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}
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},
{
"title": "Age, Continuous",
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"dispersionType": "STANDARD_DEVIATION",
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"classes": [
{
"categories": [
{
"measurements": [
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"spread": "15.4"
},
{
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{
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}
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},
{
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},
{
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},
{
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}
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},
{
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},
{
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}
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}
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}
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},
{
"title": "Ethnicity (NIH/OMB)",
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"unitOfMeasure": "Participants",
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},
{
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},
{
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},
{
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},
{
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},
{
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},
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}
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},
{
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"unitOfMeasure": "Participants",
"classes": [
{
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{
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},
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{
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{
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},
{
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},
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{
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},
{
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},
{
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},
{
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},
{
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},
{
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},
{
"title": "Disease severity",
"description": "Mild-moderate disease: SpO2 \\> 94% and respiratory rate \\< 24 breaths/min without supplemental oxygen.\n\nSevere disease: requiring mechanical ventilation, requiring oxygen, a SpO2 = 94% on room air, or tachypnea (respiratory rate = 24 breaths/min).",
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants",
"classes": [
{
"title": "Mild-to-moderate disease severity",
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "50"
},
{
"groupId": "BG001",
"value": "55"
},
{
"groupId": "BG002",
"value": "105"
}
]
}
]
},
{
"title": "Severe disease severity",
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "471"
},
{
"groupId": "BG001",
"value": "486"
},
{
"groupId": "BG002",
"value": "957"
}
]
}
]
}
]
}
]
},
"outcomeMeasuresModule": {
"outcomeMeasures": [
{
"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.",
"populationDescription": "The intent-to-treat (ITT) population includes all participants who were randomized",
"reportingStatus": "POSTED",
"paramType": "MEDIAN",
"dispersionType": "95% Confidence Interval",
"unitOfMeasure": "Days",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "521"
},
{
"groupId": "OG001",
"value": "541"
}
]
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "15",
"lowerLimit": "13",
"upperLimit": "18"
},
{
"groupId": "OG001",
"value": "10",
"lowerLimit": "9",
"upperLimit": "11"
}
]
}
]
}
],
"analyses": [
{
"groupIds": ["OG000", "OG001"],
"nonInferiorityType": "SUPERIORITY",
"pValue": "<0.001",
"statisticalMethod": "Log Rank",
"paramType": "Cox Proportional Hazard",
"paramValue": "1.29",
"ciPctValue": "95",
"ciNumSides": "TWO_SIDED",
"ciLowerLimit": "1.12",
"ciUpperLimit": "1.49"
}
]
},
{
"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.",
"populationDescription": "The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.",
"reportingStatus": "POSTED",
"paramType": "MEAN",
"dispersionType": "Standard Deviation",
"unitOfMeasure": "Units/Liter (U/L)",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "463"
},
{
"groupId": "OG001",
"value": "465"
}
]
}
],
"classes": [
{
"title": "Day 3",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "463"
},
{
"groupId": "OG001",
"value": "465"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "14.3",
"spread": "88"
},
{
"groupId": "OG001",
"value": "2.9",
"spread": "31.5"
}
]
}
]
},
{
"title": "Day 5",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "403"
},
{
"groupId": "OG001",
"value": "398"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "23.1",
"spread": "70.6"
},
{
"groupId": "OG001",
"value": "10.8",
"spread": "55.8"
}
]
}
]
},
{
"title": "Day 8",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "327"
},
{
"groupId": "OG001",
"value": "296"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "24.2",
"spread": "79.7"
},
{
"groupId": "OG001",
"value": "8.9",
"spread": "54.2"
}
]
}
]
},
{
"title": "Day 11",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "257"
},
{
"groupId": "OG001",
"value": "227"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "27.7",
"spread": "89.8"
},
{
"groupId": "OG001",
"value": "3.4",
"spread": "48.4"
}
]
}
]
},
{
"title": "Day 15",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "242"
},
{
"groupId": "OG001",
"value": "257"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "28.1",
"spread": "110.1"
},
{
"groupId": "OG001",
"value": "1.7",
"spread": "47.4"
}
]
}
]
},
{
"title": "Day 29",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "180"
},
{
"groupId": "OG001",
"value": "220"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "-3.9",
"spread": "62.2"
},
{
"groupId": "OG001",
"value": "-6.8",
"spread": "43.7"
}
]
}
]
}
]
},
{
"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.",
"populationDescription": "The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.",
"reportingStatus": "POSTED",
"paramType": "MEAN",
"dispersionType": "Standard Deviation",
"unitOfMeasure": "Units/Liter (U/L)",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "438"
},
{
"groupId": "OG001",
"value": "445"
}
]
}
],
"classes": [
{
"title": "Day 3",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "438"
},
{
"groupId": "OG001",
"value": "445"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "13.7",
"spread": "90.7"
},
{
"groupId": "OG001",
"value": "-2.0",
"spread": "29.1"
}
]
}
]
},
{
"title": "Day 5",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "384"
},
{
"groupId": "OG001",
"value": "380"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "12.8",
"spread": "66.2"
},
{
"groupId": "OG001",
"value": "6.0",
"spread": "58.9"
}
]
}
]
},
{
"title": "Day 8",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "315"
},
{
"groupId": "OG001",
"value": "285"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "13.1",
"spread": "114.6"
},
{
"groupId": "OG001",
"value": "1.1",
"spread": "55.9"
}
]
}
]
},
{
"title": "Day 11",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "247"
},
{
"groupId": "OG001",
"value": "219"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "11.5",
"spread": "78.8"
},
{
"groupId": "OG001",
"value": "-0.3",
"spread": "51.7"
}
]
}
]
},
{
"title": "Day 15",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "236"
},
{
"groupId": "OG001",
"value": "248"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "4.2",
"spread": "73.0"
},
{
"groupId": "OG001",
"value": "-2.3",
"spread": "60.4"
}
]
}
]
},
{
"title": "Day 29",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "170"
},
{
"groupId": "OG001",
"value": "208"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "-18.4",
"spread": "47.2"
},
{
"groupId": "OG001",
"value": "-14.0",
"spread": "52.2"
}
]
}
]
}
]
},
{
"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.",
"populationDescription": "The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.",
"reportingStatus": "POSTED",
"paramType": "MEAN",
"dispersionType": "Standard Deviation",
"unitOfMeasure": "milligrams/deciliter (mg/dL)",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "475"
},
{
"groupId": "OG001",
"value": "482"
}
]
}
],
"classes": [
{
"title": "Day 3",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "475"
},
{
"groupId": "OG001",
"value": "482"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.037",
"spread": "0.517"
},
{
"groupId": "OG001",
"value": "0.038",
"spread": "0.569"
}
]
}
]
},
{
"title": "Day 5",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "418"
},
{
"groupId": "OG001",
"value": "411"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "-0.695",
"spread": "17.552"
},
{
"groupId": "OG001",
"value": "0.075",
"spread": "0.762"
}
]
}
]
},
{
"title": "Day 8",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "335"
},
{
"groupId": "OG001",
"value": "309"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "-0.882",
"spread": "19.637"
},
{
"groupId": "OG001",
"value": "0.158",
"spread": "0.951"
}
]
}
]
},
{
"title": "Day 11",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "269"
},
{
"groupId": "OG001",
"value": "234"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "1.173",
"spread": "15.440"
},
{
"groupId": "OG001",
"value": "0.236",
"spread": "1.057"
}
]
}
]
},
{
"title": "Day 15",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "249"
},
{
"groupId": "OG001",
"value": "262"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "-1.239",
"spread": "22.755"
},
{
"groupId": "OG001",
"value": "0.319",
"spread": "2.147"
}
]
}
]
},
{
"title": "Day 29",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "189"
},
{
"groupId": "OG001",
"value": "229"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "-1.863",
"spread": "26.093"
},
{
"groupId": "OG001",
"value": "0.075",
"spread": "0.644"
}
]
}
]
}
]
},
{
"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.",
"populationDescription": "The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.",
"reportingStatus": "POSTED",
"paramType": "MEAN",
"dispersionType": "Standard Deviation",
"unitOfMeasure": "mg/dL",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "456"
},
{
"groupId": "OG001",
"value": "459"
}
]
}
],
"classes": [
{
"title": "Day 3",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "456"
},
{
"groupId": "OG001",
"value": "459"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "-0.2",
"spread": "53.4"
},
{
"groupId": "OG001",
"value": "-3.0",
"spread": "49.4"
}
]
}
]
},
{
"title": "Day 5",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "407"
},
{
"groupId": "OG001",
"value": "395"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "6.3",
"spread": "60.2"
},
{
"groupId": "OG001",
"value": "2.1",
"spread": "63.8"
}
]
}
]
},
{
"title": "Day 8",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "323"
},
{
"groupId": "OG001",
"value": "301"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "2.2",
"spread": "73.3"
},
{
"groupId": "OG001",
"value": "3.2",
"spread": "68.0"
}
]
}
]
},
{
"title": "Day 11",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "260"
},
{
"groupId": "OG001",
"value": "228"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "1.0",
"spread": "70.1"
},
{
"groupId": "OG001",
"value": "-0.1",
"spread": "77.4"
}
]
}
]
},
{
"title": "Day 15",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "241"
},
{
"groupId": "OG001",
"value": "250"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "-2.8",
"spread": "64.4"
},
{
"groupId": "OG001",
"value": "-2.9",
"spread": "75.4"
}
]
}
]
},
{
"title": "Day 29",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "180"
},
{
"groupId": "OG001",
"value": "219"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "-13.5",
"spread": "96.8"
},
{
"groupId": "OG001",
"value": "-11.7",
"spread": "75.4"
}
]
}
]
}
]
},
{
"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.",
"populationDescription": "The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.",
"reportingStatus": "POSTED",
"paramType": "MEAN",
"dispersionType": "Standard Deviation",
"unitOfMeasure": "grams/deciliter (g/dL)",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "475"
},
{
"groupId": "OG001",
"value": "475"
}
]
}
],
"classes": [
{
"title": "Day 3",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "475"
},
{
"groupId": "OG001",
"value": "475"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "-0.52",
"spread": "1.10"
},
{
"groupId": "OG001",
"value": "-0.69",
"spread": "5.36"
}
]
}
]
},
{
"title": "Day 5",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "420"
},
{
"groupId": "OG001",
"value": "406"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "-0.83",
"spread": "1.22"
},
{
"groupId": "OG001",
"value": "-0.99",
"spread": "5.83"
}
]
}
]
},
{
"title": "Day 8",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "334"
},
{
"groupId": "OG001",
"value": "310"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "-1.22",
"spread": "1.42"
},
{
"groupId": "OG001",
"value": "-0.49",
"spread": "6.54"
}
]
}
]
},
{
"title": "Day 11",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "269"
},
{
"groupId": "OG001",
"value": "230"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "-1.66",
"spread": "1.67"
},
{
"groupId": "OG001",
"value": "-1.29",
"spread": "1.93"
}
]
}
]
},
{
"title": "Day 15",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "253"
},
{
"groupId": "OG001",
"value": "260"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "-1.51",
"spread": "2.02"
},
{
"groupId": "OG001",
"value": "-1.02",
"spread": "3.04"
}
]
}
]
},
{
"title": "Day 29",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "189"
},
{
"groupId": "OG001",
"value": "227"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "-1.02",
"spread": "2.38"
},
{
"groupId": "OG001",
"value": "-1.21",
"spread": "7.91"
}
]
}
]
}
]
},
{
"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.",
"populationDescription": "The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.",
"reportingStatus": "POSTED",
"paramType": "MEAN",
"dispersionType": "Standard Deviation",
"unitOfMeasure": "10^9 cells/liter",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "471"
},
{
"groupId": "OG001",
"value": "474"
}
]
}
],
"classes": [
{
"title": "Day 3",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "471"
},
{
"groupId": "OG001",
"value": "474"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "39.3",
"spread": "60.0"
},
{
"groupId": "OG001",
"value": "46.0",
"spread": "62.6"
}
]
}
]
},
{
"title": "Day 5",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "419"
},
{
"groupId": "OG001",
"value": "403"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "76.5",
"spread": "100.5"
},
{
"groupId": "OG001",
"value": "90.1",
"spread": "99.9"
}
]
}
]
},
{
"title": "Day 8",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "332"
},
{
"groupId": "OG001",
"value": "308"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "111.8",
"spread": "137.4"
},
{
"groupId": "OG001",
"value": "130.8",
"spread": "128.1"
}
]
}
]
},
{
"title": "Day 11",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "269"
},
{
"groupId": "OG001",
"value": "229"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "109.3",
"spread": "149.3"
},
{
"groupId": "OG001",
"value": "101.0",
"spread": "145.0"
}
]
}
]
},
{
"title": "Day 15",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "252"
},
{
"groupId": "OG001",
"value": "258"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "96.5",
"spread": "154.2"
},
{
"groupId": "OG001",
"value": "71.1",
"spread": "133.3"
}
]
}
]
},
{
"title": "Day 29",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "189"
},
{
"groupId": "OG001",
"value": "224"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "32.7",
"spread": "124.2"
},
{
"groupId": "OG001",
"value": "39.6",
"spread": "107.4"
}
]
}
]
}
]
},
{
"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.",
"populationDescription": "The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.",
"reportingStatus": "POSTED",
"paramType": "MEAN",
"dispersionType": "Standard Deviation",
"unitOfMeasure": "seconds",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "339"
},
{
"groupId": "OG001",
"value": "352"
}
]
}
],
"classes": [
{
"title": "Day 3",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "339"
},
{
"groupId": "OG001",
"value": "352"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "-0.18",
"spread": "4.28"
},
{
"groupId": "OG001",
"value": "0.44",
"spread": "5.22"
}
]
}
]
},
{
"title": "Day 5",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "296"
},
{
"groupId": "OG001",
"value": "306"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "-0.30",
"spread": "4.72"
},
{
"groupId": "OG001",
"value": "1.15",
"spread": "5.72"
}
]
}
]
},
{
"title": "Day 8",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "246"
},
{
"groupId": "OG001",
"value": "234"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.01",
"spread": "2.59"
},
{
"groupId": "OG001",
"value": "1.43",
"spread": "3.89"
}
]
}
]
},
{
"title": "Day 11",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "199"
},
{
"groupId": "OG001",
"value": "182"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.86",
"spread": "7.85"
},
{
"groupId": "OG001",
"value": "1.88",
"spread": "5.68"
}
]
}
]
},
{
"title": "Day 15",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "176"
},
{
"groupId": "OG001",
"value": "193"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.34",
"spread": "4.33"
},
{
"groupId": "OG001",
"value": "-0.03",
"spread": "4.25"
}
]
}
]
},
{
"title": "Day 29",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "134"
},
{
"groupId": "OG001",
"value": "163"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "-0.28",
"spread": "3.20"
},
{
"groupId": "OG001",
"value": "-0.63",
"spread": "3.37"
}
]
}
]
}
]
},
{
"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.",
"populationDescription": "The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.",
"reportingStatus": "POSTED",
"paramType": "MEAN",
"dispersionType": "Standard Deviation",
"unitOfMeasure": "mg/dL",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "451"
},
{
"groupId": "OG001",
"value": "456"
}
]
}
],
"classes": [
{
"title": "Day 3",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "451"
},
{
"groupId": "OG001",
"value": "456"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.08",
"spread": "1.25"
},
{
"groupId": "OG001",
"value": "-0.04",
"spread": "0.75"
}
]
}
]
},
{
"title": "Day 5",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "394"
},
{
"groupId": "OG001",
"value": "389"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.58",
"spread": "4.13"
},
{
"groupId": "OG001",
"value": "-0.03",
"spread": "1.03"
}
]
}
]
},
{
"title": "Day 8",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "315"
},
{
"groupId": "OG001",
"value": "288"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.22",
"spread": "2.56"
},
{
"groupId": "OG001",
"value": "0.01",
"spread": "1.38"
}
]
}
]
},
{
"title": "Day 11",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "247"
},
{
"groupId": "OG001",
"value": "220"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.23",
"spread": "2.79"
},
{
"groupId": "OG001",
"value": "0.07",
"spread": "1.48"
}
]
}
]
},
{
"title": "Day 15",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "237"
},
{
"groupId": "OG001",
"value": "254"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.00",
"spread": "1.80"
},
{
"groupId": "OG001",
"value": "0.09",
"spread": "1.54"
}
]
}
]
},
{
"title": "Day 29",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "178"
},
{
"groupId": "OG001",
"value": "216"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "-0.17",
"spread": "1.65"
},
{
"groupId": "OG001",
"value": "-0.12",
"spread": "1.77"
}
]
}
]
}
]
},
{
"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.",
"populationDescription": "The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.",
"reportingStatus": "POSTED",
"paramType": "MEAN",
"dispersionType": "Standard Deviation",
"unitOfMeasure": "10^9 cells/liter",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "474"
},
{
"groupId": "OG001",
"value": "475"
}
]
}
],
"classes": [
{
"title": "Day 3",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "474"
},
{
"groupId": "OG001",
"value": "475"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "18.691",
"spread": "424.837"
},
{
"groupId": "OG001",
"value": "-18.970",
"spread": "301.944"
}
]
}
]
},
{
"title": "Day 5",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "419"
},
{
"groupId": "OG001",
"value": "405"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "9.886",
"spread": "566.175"
},
{
"groupId": "OG001",
"value": "-28.209",
"spread": "412.615"
}
]
}
]
},
{
"title": "Day 8",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "333"
},
{
"groupId": "OG001",
"value": "310"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "27.223",
"spread": "479.095"
},
{
"groupId": "OG001",
"value": "-45.997",
"spread": "602.461"
}
]
}
]
},
{
"title": "Day 11",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "268"
},
{
"groupId": "OG001",
"value": "230"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "1.967",
"spread": "16.042"
},
{
"groupId": "OG001",
"value": "-34.702",
"spread": "574.065"
}
]
}
]
},
{
"title": "Day 15",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "252"
},
{
"groupId": "OG001",
"value": "260"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "56.311",
"spread": "620.551"
},
{
"groupId": "OG001",
"value": "-70.884",
"spread": "600.011"
}
]
}
]
},
{
"title": "Day 29",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "189"
},
{
"groupId": "OG001",
"value": "226"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "-0.898",
"spread": "17.801"
},
{
"groupId": "OG001",
"value": "0.251",
"spread": "3.987"
}
]
}
]
}
]
},
{
"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.",
"populationDescription": "The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.",
"reportingStatus": "POSTED",
"paramType": "MEAN",
"dispersionType": "Standard Deviation",
"unitOfMeasure": "10^9 cells/liter",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "463"
},
{
"groupId": "OG001",
"value": "459"
}
]
}
],
"classes": [
{
"title": "Day 3",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "463"
},
{
"groupId": "OG001",
"value": "459"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "9.429",
"spread": "260.345"
},
{
"groupId": "OG001",
"value": "-8.093",
"spread": "135.068"
}
]
}
]
},
{
"title": "Day 5",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "406"
},
{
"groupId": "OG001",
"value": "389"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "4.177",
"spread": "362.782"
},
{
"groupId": "OG001",
"value": "-15.067",
"spread": "216.532"
}
]
}
]
},
{
"title": "Day 8",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "317"
},
{
"groupId": "OG001",
"value": "298"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "17.916",
"spread": "305.321"
},
{
"groupId": "OG001",
"value": "-28.179",
"spread": "365.099"
}
]
}
]
},
{
"title": "Day 11",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "257"
},
{
"groupId": "OG001",
"value": "220"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "3.010",
"spread": "27.502"
},
{
"groupId": "OG001",
"value": "-21.773",
"spread": "354.025"
}
]
}
]
},
{
"title": "Day 15",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "241"
},
{
"groupId": "OG001",
"value": "253"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "36.024",
"spread": "389.093"
},
{
"groupId": "OG001",
"value": "-39.988",
"spread": "333.088"
}
]
}
]
},
{
"title": "Day 29",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "177"
},
{
"groupId": "OG001",
"value": "218"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "-1.269",
"spread": "7.160"
},
{
"groupId": "OG001",
"value": "-0.840",
"spread": "3.666"
}
]
}
]
}
]
},
{
"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.",
"populationDescription": "The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.",
"reportingStatus": "POSTED",
"paramType": "MEAN",
"dispersionType": "Standard Deviation",
"unitOfMeasure": "10^9 cells/liter",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "463"
},
{
"groupId": "OG001",
"value": "459"
}
]
}
],
"classes": [
{
"title": "Day 3",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "463"
},
{
"groupId": "OG001",
"value": "459"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "5.883",
"spread": "118.740"
},
{
"groupId": "OG001",
"value": "-7.847",
"spread": "131.548"
}
]
}
]
},
{
"title": "Day 5",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "406"
},
{
"groupId": "OG001",
"value": "389"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "4.064",
"spread": "141.580"
},
{
"groupId": "OG001",
"value": "-11.723",
"spread": "167.428"
}
]
}
]
},
{
"title": "Day 8",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "317"
},
{
"groupId": "OG001",
"value": "299"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "8.006",
"spread": "137.149"
},
{
"groupId": "OG001",
"value": "-15.455",
"spread": "194.111"
}
]
}
]
},
{
"title": "Day 11",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "257"
},
{
"groupId": "OG001",
"value": "220"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.393",
"spread": "1.371"
},
{
"groupId": "OG001",
"value": "-12.016",
"spread": "183.060"
}
]
}
]
},
{
"title": "Day 15",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "241"
},
{
"groupId": "OG001",
"value": "253"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "14.793",
"spread": "159.583"
},
{
"groupId": "OG001",
"value": "-23.836",
"spread": "218.653"
}
]
}
]
},
{
"title": "Day 29",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "177"
},
{
"groupId": "OG001",
"value": "218"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.668",
"spread": "1.406"
},
{
"groupId": "OG001",
"value": "0.743",
"spread": "0.664"
}
]
}
]
}
]
},
{
"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.",
"populationDescription": "The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.",
"reportingStatus": "POSTED",
"paramType": "MEAN",
"dispersionType": "Standard Deviation",
"unitOfMeasure": "10^9 cells/liter",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "463"
},
{
"groupId": "OG001",
"value": "458"
}
]
}
],
"classes": [
{
"title": "Day 3",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "463"
},
{
"groupId": "OG001",
"value": "458"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "2.448",
"spread": "41.304"
},
{
"groupId": "OG001",
"value": "-2.940",
"spread": "46.752"
}
]
}
]
},
{
"title": "Day 5",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "406"
},
{
"groupId": "OG001",
"value": "388"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "1.498",
"spread": "57.686"
},
{
"groupId": "OG001",
"value": "-2.628",
"spread": "39.329"
}
]
}
]
},
{
"title": "Day 8",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "316"
},
{
"groupId": "OG001",
"value": "299"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "2.324",
"spread": "36.626"
},
{
"groupId": "OG001",
"value": "-3.645",
"spread": "48.636"
}
]
}
]
},
{
"title": "Day 11",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "257"
},
{
"groupId": "OG001",
"value": "220"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.383",
"spread": "0.744"
},
{
"groupId": "OG001",
"value": "-2.539",
"spread": "43.454"
}
]
}
]
},
{
"title": "Day 15",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "241"
},
{
"groupId": "OG001",
"value": "253"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "6.475",
"spread": "69.019"
},
{
"groupId": "OG001",
"value": "-8.738",
"spread": "74.365"
}
]
}
]
},
{
"title": "Day 29",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "177"
},
{
"groupId": "OG001",
"value": "218"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.125",
"spread": "0.485"
},
{
"groupId": "OG001",
"value": "0.117",
"spread": "0.340"
}
]
}
]
}
]
},
{
"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.",
"populationDescription": "The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.",
"reportingStatus": "POSTED",
"paramType": "MEAN",
"dispersionType": "Standard Deviation",
"unitOfMeasure": "10^9 cells/liter",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "455"
},
{
"groupId": "OG001",
"value": "452"
}
]
}
],
"classes": [
{
"title": "Day 3",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "455"
},
{
"groupId": "OG001",
"value": "452"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.020",
"spread": "0.257"
},
{
"groupId": "OG001",
"value": "0.005",
"spread": "0.043"
}
]
}
]
},
{
"title": "Day 5",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "394"
},
{
"groupId": "OG001",
"value": "380"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.038",
"spread": "0.501"
},
{
"groupId": "OG001",
"value": "0.005",
"spread": "0.370"
}
]
}
]
},
{
"title": "Day 8",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "309"
},
{
"groupId": "OG001",
"value": "293"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.196",
"spread": "3.132"
},
{
"groupId": "OG001",
"value": "0.005",
"spread": "0.368"
}
]
}
]
},
{
"title": "Day 11",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "253"
},
{
"groupId": "OG001",
"value": "218"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.024",
"spread": "0.042"
},
{
"groupId": "OG001",
"value": "0.028",
"spread": "0.053"
}
]
}
]
},
{
"title": "Day 15",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "235"
},
{
"groupId": "OG001",
"value": "248"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.158",
"spread": "1.913"
},
{
"groupId": "OG001",
"value": "-0.058",
"spread": "1.028"
}
]
}
]
},
{
"title": "Day 29",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "176"
},
{
"groupId": "OG001",
"value": "216"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.040",
"spread": "0.073"
},
{
"groupId": "OG001",
"value": "0.029",
"spread": "0.054"
}
]
}
]
}
]
},
{
"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.",
"populationDescription": "The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.",
"reportingStatus": "POSTED",
"paramType": "MEAN",
"dispersionType": "Standard Deviation",
"unitOfMeasure": "10^9 cells/liter",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "456"
},
{
"groupId": "OG001",
"value": "455"
}
]
}
],
"classes": [
{
"title": "Day 3",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "456"
},
{
"groupId": "OG001",
"value": "455"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.634",
"spread": "10.614"
},
{
"groupId": "OG001",
"value": "0.016",
"spread": "0.727"
}
]
}
]
},
{
"title": "Day 5",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "397"
},
{
"groupId": "OG001",
"value": "387"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.666",
"spread": "11.977"
},
{
"groupId": "OG001",
"value": "-0.066",
"spread": "2.807"
}
]
}
]
},
{
"title": "Day 8",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "311"
},
{
"groupId": "OG001",
"value": "293"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.596",
"spread": "8.875"
},
{
"groupId": "OG001",
"value": "-0.221",
"spread": "4.108"
}
]
}
]
},
{
"title": "Day 11",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "254"
},
{
"groupId": "OG001",
"value": "218"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.093",
"spread": "0.190"
},
{
"groupId": "OG001",
"value": "-0.088",
"spread": "2.973"
}
]
}
]
},
{
"title": "Day 15",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "237"
},
{
"groupId": "OG001",
"value": "251"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "1.992",
"spread": "20.365"
},
{
"groupId": "OG001",
"value": "-0.420",
"spread": "5.378"
}
]
}
]
},
{
"title": "Day 29",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "176"
},
{
"groupId": "OG001",
"value": "217"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.241",
"spread": "0.324"
},
{
"groupId": "OG001",
"value": "0.211",
"spread": "0.267"
}
]
}
]
}
]
},
{
"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.",
"populationDescription": "The intent-to-treat (ITT) population includes all participants who were randomized with data at baseline and at each timepoint.",
"reportingStatus": "POSTED",
"paramType": "MEAN",
"dispersionType": "Standard Deviation",
"unitOfMeasure": "units on a scale",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "499"
},
{
"groupId": "OG001",
"value": "502"
}
]
}
],
"classes": [
{
"title": "Day 3",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "499"
},
{
"groupId": "OG001",
"value": "502"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.1",
"spread": "2.8"
},
{
"groupId": "OG001",
"value": "-0.3",
"spread": "2.6"
}
]
}
]
},
{
"title": "Day 5",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "447"
},
{
"groupId": "OG001",
"value": "438"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.3",
"spread": "3.3"
},
{
"groupId": "OG001",
"value": "-0.4",
"spread": "2.9"
}
]
}
]
},
{
"title": "Day 8",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "348"
},
{
"groupId": "OG001",
"value": "321"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "-0.3",
"spread": "3.8"
},
{
"groupId": "OG001",
"value": "-0.5",
"spread": "3.2"
}
]
}
]
},
{
"title": "Day 11",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "291"
},
{
"groupId": "OG001",
"value": "254"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "-0.3",
"spread": "4.1"
},
{
"groupId": "OG001",
"value": "-0.5",
"spread": "3.5"
}
]
}
]
},
{
"title": "Day 15",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "290"
},
{
"groupId": "OG001",
"value": "301"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "-1.4",
"spread": "4.2"
},
{
"groupId": "OG001",
"value": "-1.7",
"spread": "3.6"
}
]
}
]
},
{
"title": "Day 22",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "151"
},
{
"groupId": "OG001",
"value": "120"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "-1.4",
"spread": "4.0"
},
{
"groupId": "OG001",
"value": "-1.7",
"spread": "4.1"
}
]
}
]
},
{
"title": "Day 29",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "221"
},
{
"groupId": "OG001",
"value": "251"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "-3.2",
"spread": "4.0"
},
{
"groupId": "OG001",
"value": "-3.3",
"spread": "3.2"
}
]
}
]
}
]
},
{
"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.",
"populationDescription": "The intent-to-treat (ITT) population includes all participants who were randomized",
"reportingStatus": "POSTED",
"paramType": "NUMBER",
"dispersionType": "95% Confidence Interval",
"unitOfMeasure": "percentage of participants",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "521"
},
{
"groupId": "OG001",
"value": "541"
}
]
}
],
"classes": [
{
"title": "Death at or before study Visit",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0",
"lowerLimit": "0",
"upperLimit": "1"
},
{
"groupId": "OG001",
"value": "0",
"lowerLimit": "0",
"upperLimit": "1"
}
]
}
]
},
{
"title": "Hospitalized, on invasive mech. vent. or ECMO",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "30",
"lowerLimit": "26",
"upperLimit": "34"
},
{
"groupId": "OG001",
"value": "24",
"lowerLimit": "21",
"upperLimit": "28"
}
]
}
]
},
{
"title": "Hospitalized, on non-invasive vent./high flow O2",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "19",
"lowerLimit": "16",
"upperLimit": "22"
},
{
"groupId": "OG001",
"value": "18",
"lowerLimit": "15",
"upperLimit": "21"
}
]
}
]
},
{
"title": "Hospitalized, requiring supplemental oxygen",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "39",
"lowerLimit": "35",
"upperLimit": "43"
},
{
"groupId": "OG001",
"value": "43",
"lowerLimit": "39",
"upperLimit": "47"
}
]
}
]
},
{
"title": "Hospitalized, not on O2, requiring ongoing care",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "12",
"lowerLimit": "10",
"upperLimit": "15"
},
{
"groupId": "OG001",
"value": "14",
"lowerLimit": "11",
"upperLimit": "17"
}
]
}
]
},
{
"title": "Hospitalized, not requiring O2, no longer req care",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0",
"lowerLimit": "0",
"upperLimit": "1"
},
{
"groupId": "OG001",
"value": "0",
"lowerLimit": "0",
"upperLimit": "1"
}
]
}
]
},
{
"title": "Not hospitalized, limit on activities/req home O2",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0",
"lowerLimit": "0",
"upperLimit": "1"
},
{
"groupId": "OG001",
"value": "0",
"lowerLimit": "0",
"upperLimit": "1"
}
]
}
]
},
{
"title": "Not hospitalized, no limitations on activities",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0",
"lowerLimit": "0",
"upperLimit": "1"
},
{
"groupId": "OG001",
"value": "0",
"lowerLimit": "0",
"upperLimit": "1"
}
]
}
]
},
{
"title": "No clinical status score reported - Hospitalized",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0",
"lowerLimit": "0",
"upperLimit": "1"
},
{
"groupId": "OG001",
"value": "1",
"lowerLimit": "0",
"upperLimit": "2"
}
]
}
]
},
{
"title": "No clinical status score reported - Discharged",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0",
"lowerLimit": "0",
"upperLimit": "1"
},
{
"groupId": "OG001",
"value": "0",
"lowerLimit": "0",
"upperLimit": "1"
}
]
}
]
},
{
"title": "No clinical status score reported - Discontinued",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "1",
"lowerLimit": "0",
"upperLimit": "2"
},
{
"groupId": "OG001",
"value": "1",
"lowerLimit": "0",
"upperLimit": "2"
}
]
}
]
}
]
},
{
"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.",
"populationDescription": "The intent-to-treat (ITT) population includes all participants who were randomized",
"reportingStatus": "POSTED",
"paramType": "NUMBER",
"dispersionType": "95% Confidence Interval",
"unitOfMeasure": "percentage of participants",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "521"
},
{
"groupId": "OG001",
"value": "541"
}
]
}
],
"classes": [
{
"title": "Death at or before study Visit",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "1",
"lowerLimit": "1",
"upperLimit": "3"
},
{
"groupId": "OG001",
"value": "1",
"lowerLimit": "0",
"upperLimit": "2"
}
]
}
]
},
{
"title": "Hospitalized, on invasive mech. vent. or ECMO",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "36",
"lowerLimit": "32",
"upperLimit": "40"
},
{
"groupId": "OG001",
"value": "28",
"lowerLimit": "25",
"upperLimit": "32"
}
]
}
]
},
{
"title": "Hospitalized, on non-invasive vent./high flow O2",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "17",
"lowerLimit": "14",
"upperLimit": "21"
},
{
"groupId": "OG001",
"value": "16",
"lowerLimit": "13",
"upperLimit": "19"
}
]
}
]
},
{
"title": "Hospitalized, requiring supplemental oxygen",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "32",
"lowerLimit": "29",
"upperLimit": "37"
},
{
"groupId": "OG001",
"value": "37",
"lowerLimit": "33",
"upperLimit": "41"
}
]
}
]
},
{
"title": "Hospitalized, not on O2, requiring ongoing care",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "12",
"lowerLimit": "9",
"upperLimit": "15"
},
{
"groupId": "OG001",
"value": "13",
"lowerLimit": "10",
"upperLimit": "16"
}
]
}
]
},
{
"title": "Hospitalized, not requiring O2, no longer req care",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.4",
"lowerLimit": "0",
"upperLimit": "1"
},
{
"groupId": "OG001",
"value": "0.2",
"lowerLimit": "0",
"upperLimit": "1"
}
]
}
]
},
{
"title": "Not hospitalized, limit on activities/req home O2",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0",
"lowerLimit": "0",
"upperLimit": "1"
},
{
"groupId": "OG001",
"value": "0",
"lowerLimit": "0",
"upperLimit": "1"
}
]
}
]
},
{
"title": "Not hospitalized, no limitations on activities",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0",
"lowerLimit": "0",
"upperLimit": "1"
},
{
"groupId": "OG001",
"value": "0.4",
"lowerLimit": "0",
"upperLimit": "1"
}
]
}
]
},
{
"title": "No clinical status score reported - Hospitalized",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0",
"lowerLimit": "0",
"upperLimit": "1"
},
{
"groupId": "OG001",
"value": "0",
"lowerLimit": "0",
"upperLimit": "1"
}
]
}
]
},
{
"title": "No clinical status score reported - Discharged",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.2",
"lowerLimit": "0",
"upperLimit": "1"
},
{
"groupId": "OG001",
"value": "2",
"lowerLimit": "1",
"upperLimit": "4"
}
]
}
]
},
{
"title": "No clinical status score reported - Discontinued",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "1",
"lowerLimit": "0",
"upperLimit": "2"
},
{
"groupId": "OG001",
"value": "2",
"lowerLimit": "1",
"upperLimit": "4"
}
]
}
]
}
]
},
{
"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.",
"populationDescription": "The intent-to-treat (ITT) population includes all participants who were randomized",
"reportingStatus": "POSTED",
"paramType": "NUMBER",
"dispersionType": "95% Confidence Interval",
"unitOfMeasure": "percentage of participants",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "521"
},
{
"groupId": "OG001",
"value": "541"
}
]
}
],
"classes": [
{
"title": "Death at or before study Visit",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "2",
"lowerLimit": "1",
"upperLimit": "4"
},
{
"groupId": "OG001",
"value": "2",
"lowerLimit": "1",
"upperLimit": "4"
}
]
}
]
},
{
"title": "Hospitalized, on invasive mech. vent. or ECMO",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "37",
"lowerLimit": "33",
"upperLimit": "41"
},
{
"groupId": "OG001",
"value": "28",
"lowerLimit": "24",
"upperLimit": "32"
}
]
}
]
},
{
"title": "Hospitalized, on non-invasive vent./high flow O2",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "14",
"lowerLimit": "12",
"upperLimit": "18"
},
{
"groupId": "OG001",
"value": "12",
"lowerLimit": "9",
"upperLimit": "15"
}
]
}
]
},
{
"title": "Hospitalized, requiring supplemental oxygen",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "26",
"lowerLimit": "23",
"upperLimit": "30"
},
{
"groupId": "OG001",
"value": "28",
"lowerLimit": "24",
"upperLimit": "31"
}
]
}
]
},
{
"title": "Hospitalized, not on O2, requiring ongoing care",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "11",
"lowerLimit": "8",
"upperLimit": "13"
},
{
"groupId": "OG001",
"value": "15",
"lowerLimit": "12",
"upperLimit": "18"
}
]
}
]
},
{
"title": "Hospitalized, not requiring O2, no longer req care",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "1",
"lowerLimit": "0",
"upperLimit": "2"
},
{
"groupId": "OG001",
"value": "1",
"lowerLimit": "0",
"upperLimit": "2"
}
]
}
]
},
{
"title": "Not hospitalized, limit on activities/req home O2",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0",
"lowerLimit": "0",
"upperLimit": "1"
},
{
"groupId": "OG001",
"value": "0.2",
"lowerLimit": "0",
"upperLimit": "1"
}
]
}
]
},
{
"title": "Not hospitalized, no limitations on activities",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.2",
"lowerLimit": "0",
"upperLimit": "1"
},
{
"groupId": "OG001",
"value": "0",
"lowerLimit": "0",
"upperLimit": "1"
}
]
}
]
},
{
"title": "No clinical status score reported - Hospitalized",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0",
"lowerLimit": "0",
"upperLimit": "1"
},
{
"groupId": "OG001",
"value": "0",
"lowerLimit": "0",
"upperLimit": "1"
}
]
}
]
},
{
"title": "No clinical status score reported - Discharged",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "7",
"lowerLimit": "5",
"upperLimit": "9"
},
{
"groupId": "OG001",
"value": "12",
"lowerLimit": "9",
"upperLimit": "15"
}
]
}
]
},
{
"title": "No clinical status score reported - Discontinued",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "2",
"lowerLimit": "1",
"upperLimit": "3"
},
{
"groupId": "OG001",
"value": "3",
"lowerLimit": "2",
"upperLimit": "5"
}
]
}
]
}
]
},
{
"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.",
"populationDescription": "The intent-to-treat (ITT) population includes all participants who were randomized",
"reportingStatus": "POSTED",
"paramType": "NUMBER",
"dispersionType": "95% Confidence Interval",
"unitOfMeasure": "percentage of participants",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "521"
},
{
"groupId": "OG001",
"value": "541"
}
]
}
],
"classes": [
{
"title": "Death at or before study Visit",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "7",
"lowerLimit": "5",
"upperLimit": "9"
},
{
"groupId": "OG001",
"value": "3",
"lowerLimit": "2",
"upperLimit": "5"
}
]
}
]
},
{
"title": "Hospitalized, on invasive mech. vent. or ECMO",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "33",
"lowerLimit": "29",
"upperLimit": "37"
},
{
"groupId": "OG001",
"value": "24",
"lowerLimit": "21",
"upperLimit": "28"
}
]
}
]
},
{
"title": "Hospitalized, on non-invasive vent./high flow O2",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "9",
"lowerLimit": "7",
"upperLimit": "12"
},
{
"groupId": "OG001",
"value": "9",
"lowerLimit": "7",
"upperLimit": "12"
}
]
}
]
},
{
"title": "Hospitalized, requiring supplemental oxygen",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "15",
"lowerLimit": "13",
"upperLimit": "19"
},
{
"groupId": "OG001",
"value": "17",
"lowerLimit": "14",
"upperLimit": "21"
}
]
}
]
},
{
"title": "Hospitalized, not on O2, requiring ongoing care",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "10",
"lowerLimit": "8",
"upperLimit": "13"
},
{
"groupId": "OG001",
"value": "11",
"lowerLimit": "9",
"upperLimit": "14"
}
]
}
]
},
{
"title": "Hospitalized, not requiring O2, no longer req care",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "1",
"lowerLimit": "1",
"upperLimit": "3"
},
{
"groupId": "OG001",
"value": "1",
"lowerLimit": "1",
"upperLimit": "3"
}
]
}
]
},
{
"title": "Not hospitalized, limit on activities/req home O2",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0",
"lowerLimit": "0",
"upperLimit": "1"
},
{
"groupId": "OG001",
"value": "0.2",
"lowerLimit": "0",
"upperLimit": "1"
}
]
}
]
},
{
"title": "Not hospitalized, no limitations on activities",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.2",
"lowerLimit": "0",
"upperLimit": "1"
},
{
"groupId": "OG001",
"value": "0",
"lowerLimit": "0",
"upperLimit": "1"
}
]
}
]
},
{
"title": "No clinical status score reported - Hospitalized",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0",
"lowerLimit": "0",
"upperLimit": "1"
},
{
"groupId": "OG001",
"value": "0.4",
"lowerLimit": "0",
"upperLimit": "1"
}
]
}
]
},
{
"title": "No clinical status score reported - Discharged",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "22",
"lowerLimit": "19",
"upperLimit": "26"
},
{
"groupId": "OG001",
"value": "30",
"lowerLimit": "27",
"upperLimit": "34"
}
]
}
]
},
{
"title": "No clinical status score reported - Discontinued",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "2",
"lowerLimit": "1",
"upperLimit": "3"
},
{
"groupId": "OG001",
"value": "4",
"lowerLimit": "2",
"upperLimit": "5"
}
]
}
]
}
]
},
{
"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.",
"populationDescription": "The intent-to-treat (ITT) population includes all participants who were randomized",
"reportingStatus": "POSTED",
"paramType": "NUMBER",
"dispersionType": "95% Confidence Interval",
"unitOfMeasure": "percentage of participants",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "521"
},
{
"groupId": "OG001",
"value": "541"
}
]
}
],
"classes": [
{
"title": "Death at or before study Visit",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "8",
"lowerLimit": "6",
"upperLimit": "11"
},
{
"groupId": "OG001",
"value": "4",
"lowerLimit": "3",
"upperLimit": "6"
}
]
}
]
},
{
"title": "Hospitalized, on invasive mech. vent. or ECMO",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "28",
"lowerLimit": "25",
"upperLimit": "32"
},
{
"groupId": "OG001",
"value": "22",
"lowerLimit": "19",
"upperLimit": "26"
}
]
}
]
},
{
"title": "Hospitalized, on non-invasive vent./high flow O2",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "7",
"lowerLimit": "5",
"upperLimit": "10"
},
{
"groupId": "OG001",
"value": "6",
"lowerLimit": "4",
"upperLimit": "8"
}
]
}
]
},
{
"title": "Hospitalized, requiring supplemental oxygen",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "13",
"lowerLimit": "10",
"upperLimit": "16"
},
{
"groupId": "OG001",
"value": "11",
"lowerLimit": "9",
"upperLimit": "14"
}
]
}
]
},
{
"title": "Hospitalized, not on O2, requiring ongoing care",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "6",
"lowerLimit": "5",
"upperLimit": "9"
},
{
"groupId": "OG001",
"value": "7",
"lowerLimit": "5",
"upperLimit": "9"
}
]
}
]
},
{
"title": "Hospitalized, not requiring O2, no longer req care",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "2",
"lowerLimit": "1",
"upperLimit": "4"
},
{
"groupId": "OG001",
"value": "2",
"lowerLimit": "1",
"upperLimit": "4"
}
]
}
]
},
{
"title": "Not hospitalized, limit on activities/req home O2",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.4",
"lowerLimit": "0",
"upperLimit": "1"
},
{
"groupId": "OG001",
"value": "0.4",
"lowerLimit": "0",
"upperLimit": "1"
}
]
}
]
},
{
"title": "Not hospitalized, no limitations on activities",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.2",
"lowerLimit": "0",
"upperLimit": "1"
},
{
"groupId": "OG001",
"value": "0",
"lowerLimit": "0",
"upperLimit": "1"
}
]
}
]
},
{
"title": "No clinical status score reported - Hospitalized",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0",
"lowerLimit": "0",
"upperLimit": "1"
},
{
"groupId": "OG001",
"value": "0",
"lowerLimit": "0",
"upperLimit": "1"
}
]
}
]
},
{
"title": "No clinical status score reported - Discharged",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "33",
"lowerLimit": "29",
"upperLimit": "37"
},
{
"groupId": "OG001",
"value": "44",
"lowerLimit": "40",
"upperLimit": "48"
}
]
}
]
},
{
"title": "No clinical status score reported - Discontinued",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "2",
"lowerLimit": "1",
"upperLimit": "4"
},
{
"groupId": "OG001",
"value": "4",
"lowerLimit": "3",
"upperLimit": "6"
}
]
}
]
}
]
},
{
"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.",
"populationDescription": "The intent-to-treat (ITT) population includes all participants who were randomized",
"reportingStatus": "POSTED",
"paramType": "NUMBER",
"dispersionType": "95% Confidence Interval",
"unitOfMeasure": "percentage of participants",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "521"
},
{
"groupId": "OG001",
"value": "541"
}
]
}
],
"classes": [
{
"title": "Death at or before study Visit",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "11",
"lowerLimit": "9",
"upperLimit": "14"
},
{
"groupId": "OG001",
"value": "6",
"lowerLimit": "5",
"upperLimit": "9"
}
]
}
]
},
{
"title": "Hospitalized, on invasive mech. vent. or ECMO",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "22",
"lowerLimit": "19",
"upperLimit": "26"
},
{
"groupId": "OG001",
"value": "15",
"lowerLimit": "13",
"upperLimit": "19"
}
]
}
]
},
{
"title": "Hospitalized, on non-invasive vent./high flow O2",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "4",
"lowerLimit": "3",
"upperLimit": "6"
},
{
"groupId": "OG001",
"value": "4",
"lowerLimit": "3",
"upperLimit": "6"
}
]
}
]
},
{
"title": "Hospitalized, requiring supplemental oxygen",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "11",
"lowerLimit": "9",
"upperLimit": "14"
},
{
"groupId": "OG001",
"value": "10",
"lowerLimit": "8",
"upperLimit": "13"
}
]
}
]
},
{
"title": "Hospitalized, not on O2, requiring ongoing care",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "6",
"lowerLimit": "5",
"upperLimit": "9"
},
{
"groupId": "OG001",
"value": "7",
"lowerLimit": "5",
"upperLimit": "9"
}
]
}
]
},
{
"title": "Hospitalized, not requiring O2, no longer req care",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "2",
"lowerLimit": "1",
"upperLimit": "3"
},
{
"groupId": "OG001",
"value": "3",
"lowerLimit": "2",
"upperLimit": "4"
}
]
}
]
},
{
"title": "Not hospitalized, limit on activities/req home O2",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "17",
"lowerLimit": "14",
"upperLimit": "21"
},
{
"groupId": "OG001",
"value": "19",
"lowerLimit": "16",
"upperLimit": "22"
}
]
}
]
},
{
"title": "Not hospitalized, no limitations on activities",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "22",
"lowerLimit": "19",
"upperLimit": "26"
},
{
"groupId": "OG001",
"value": "29",
"lowerLimit": "25",
"upperLimit": "33"
}
]
}
]
},
{
"title": "No clinical status score reported - Hospitalized",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0",
"lowerLimit": "0",
"upperLimit": "1"
},
{
"groupId": "OG001",
"value": "0",
"lowerLimit": "0",
"upperLimit": "1"
}
]
}
]
},
{
"title": "No clinical status score reported - Discharged",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "2",
"lowerLimit": "1",
"upperLimit": "3"
},
{
"groupId": "OG001",
"value": "2",
"lowerLimit": "1",
"upperLimit": "4"
}
]
}
]
},
{
"title": "No clinical status score reported - Discontinued",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "3",
"lowerLimit": "2",
"upperLimit": "4"
},
{
"groupId": "OG001",
"value": "5",
"lowerLimit": "3",
"upperLimit": "7"
}
]
}
]
}
]
},
{
"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.",
"populationDescription": "The intent-to-treat (ITT) population includes all participants who were randomized",
"reportingStatus": "POSTED",
"paramType": "NUMBER",
"dispersionType": "95% Confidence Interval",
"unitOfMeasure": "percentage of participants",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "521"
},
{
"groupId": "OG001",
"value": "541"
}
]
}
],
"classes": [
{
"title": "Death at or before study Visit",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "13",
"lowerLimit": "10",
"upperLimit": "16"
},
{
"groupId": "OG001",
"value": "9",
"lowerLimit": "7",
"upperLimit": "12"
}
]
}
]
},
{
"title": "Hospitalized, on invasive mech. vent. or ECMO",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "14",
"lowerLimit": "12",
"upperLimit": "18"
},
{
"groupId": "OG001",
"value": "9",
"lowerLimit": "7",
"upperLimit": "12"
}
]
}
]
},
{
"title": "Hospitalized, on non-invasive vent./high flow O2",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "2",
"lowerLimit": "1",
"upperLimit": "4"
},
{
"groupId": "OG001",
"value": "2",
"lowerLimit": "1",
"upperLimit": "4"
}
]
}
]
},
{
"title": "Hospitalized, requiring supplemental oxygen",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "8",
"lowerLimit": "6",
"upperLimit": "11"
},
{
"groupId": "OG001",
"value": "5",
"lowerLimit": "4",
"upperLimit": "8"
}
]
}
]
},
{
"title": "Hospitalized, not on O2, requiring ongoing care",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "5",
"lowerLimit": "4",
"upperLimit": "8"
},
{
"groupId": "OG001",
"value": "6",
"lowerLimit": "4",
"upperLimit": "8"
}
]
}
]
},
{
"title": "Hospitalized, not requiring O2, no longer req care",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "1",
"lowerLimit": "0",
"upperLimit": "2"
},
{
"groupId": "OG001",
"value": "1",
"lowerLimit": "1",
"upperLimit": "3"
}
]
}
]
},
{
"title": "Not hospitalized, limit on activities/req home O2",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "18",
"lowerLimit": "15",
"upperLimit": "22"
},
{
"groupId": "OG001",
"value": "19",
"lowerLimit": "16",
"upperLimit": "23"
}
]
}
]
},
{
"title": "Not hospitalized, no limitations on activities",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "32",
"lowerLimit": "29",
"upperLimit": "37"
},
{
"groupId": "OG001",
"value": "39",
"lowerLimit": "35",
"upperLimit": "43"
}
]
}
]
},
{
"title": "No clinical status score reported - Hospitalized",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0",
"lowerLimit": "0",
"upperLimit": "1"
},
{
"groupId": "OG001",
"value": "0",
"lowerLimit": "0",
"upperLimit": "1"
}
]
}
]
},
{
"title": "No clinical status score reported - Discharged",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "2",
"lowerLimit": "1",
"upperLimit": "4"
},
{
"groupId": "OG001",
"value": "3",
"lowerLimit": "2",
"upperLimit": "5"
}
]
}
]
},
{
"title": "No clinical status score reported - Discontinued",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "4",
"lowerLimit": "2",
"upperLimit": "6"
},
{
"groupId": "OG001",
"value": "6",
"lowerLimit": "4",
"upperLimit": "8"
}
]
}
]
},
{
"title": "Completed study without reporting score",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0",
"lowerLimit": "0",
"upperLimit": "1"
},
{
"groupId": "OG001",
"value": "0.2",
"lowerLimit": "0",
"upperLimit": "1"
}
]
}
]
}
]
},
{
"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.",
"populationDescription": "The intent-to-treat (ITT) population includes all participants who were randomized",
"reportingStatus": "POSTED",
"paramType": "NUMBER",
"dispersionType": "95% Confidence Interval",
"unitOfMeasure": "percentage of participants",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "521"
},
{
"groupId": "OG001",
"value": "541"
}
]
}
],
"classes": [
{
"title": "Death at or before study Visit",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "15",
"lowerLimit": "12",
"upperLimit": "18"
},
{
"groupId": "OG001",
"value": "11",
"lowerLimit": "8",
"upperLimit": "14"
}
]
}
]
},
{
"title": "Hospitalized, on invasive mech. vent. or ECMO",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "9",
"lowerLimit": "7",
"upperLimit": "11"
},
{
"groupId": "OG001",
"value": "6",
"lowerLimit": "4",
"upperLimit": "8"
}
]
}
]
},
{
"title": "Hospitalized, on non-invasive vent./high flow O2",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "2",
"lowerLimit": "1",
"upperLimit": "3"
},
{
"groupId": "OG001",
"value": "1",
"lowerLimit": "0",
"upperLimit": "2"
}
]
}
]
},
{
"title": "Hospitalized, requiring supplemental oxygen",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "4",
"lowerLimit": "3",
"upperLimit": "6"
},
{
"groupId": "OG001",
"value": "4",
"lowerLimit": "3",
"upperLimit": "6"
}
]
}
]
},
{
"title": "Hospitalized, not on O2, requiring ongoing care",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "3",
"lowerLimit": "2",
"upperLimit": "5"
},
{
"groupId": "OG001",
"value": "3",
"lowerLimit": "2",
"upperLimit": "5"
}
]
}
]
},
{
"title": "Hospitalized, not requiring O2, no longer req care",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "1",
"lowerLimit": "0",
"upperLimit": "2"
},
{
"groupId": "OG001",
"value": "1",
"lowerLimit": "0",
"upperLimit": "2"
}
]
}
]
},
{
"title": "Not hospitalized, limit on activities/req home O2",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "19",
"lowerLimit": "16",
"upperLimit": "23"
},
{
"groupId": "OG001",
"value": "20",
"lowerLimit": "17",
"upperLimit": "23"
}
]
}
]
},
{
"title": "Not hospitalized, no limitations on activities",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "36",
"lowerLimit": "32",
"upperLimit": "41"
},
{
"groupId": "OG001",
"value": "46",
"lowerLimit": "42",
"upperLimit": "50"
}
]
}
]
},
{
"title": "No clinical status score reported - Hospitalized",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.2",
"lowerLimit": "0",
"upperLimit": "1"
},
{
"groupId": "OG001",
"value": "0",
"lowerLimit": "0",
"upperLimit": "1"
}
]
}
]
},
{
"title": "No clinical status score reported - Discharged",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "3",
"lowerLimit": "2",
"upperLimit": "5"
},
{
"groupId": "OG001",
"value": "1",
"lowerLimit": "1",
"upperLimit": "3"
}
]
}
]
},
{
"title": "No clinical status score reported - Discontinued",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "5",
"lowerLimit": "3",
"upperLimit": "7"
},
{
"groupId": "OG001",
"value": "7",
"lowerLimit": "5",
"upperLimit": "9"
}
]
}
]
},
{
"title": "Completed study without reporting score",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "3",
"lowerLimit": "2",
"upperLimit": "4"
},
{
"groupId": "OG001",
"value": "2",
"lowerLimit": "1",
"upperLimit": "4"
}
]
}
]
}
]
},
{
"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.",
"populationDescription": "The safety population includes all participants with available data post baseline, analyzed as treated.",
"reportingStatus": "POSTED",
"paramType": "NUMBER",
"dispersionType": "95% Confidence Interval",
"unitOfMeasure": "percentage of participants",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "516"
},
{
"groupId": "OG001",
"value": "532"
}
]
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "57",
"lowerLimit": "52.8",
"upperLimit": "61.5"
},
{
"groupId": "OG001",
"value": "51",
"lowerLimit": "47.0",
"upperLimit": "55.6"
}
]
}
]
}
],
"analyses": [
{
"groupIds": ["OG000", "OG001"],
"nonInferiorityType": "SUPERIORITY",
"pValue": "0.058",
"statisticalMethod": "Barnard's Exact Test"
}
]
},
{
"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.",
"populationDescription": "The safety population includes all participants with available data post baseline, analyzed as treated.",
"reportingStatus": "POSTED",
"paramType": "NUMBER",
"dispersionType": "95% Confidence Interval",
"unitOfMeasure": "percentage of participants",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "516"
},
{
"groupId": "OG001",
"value": "532"
}
]
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "32",
"lowerLimit": "27.7",
"upperLimit": "35.7"
},
{
"groupId": "OG001",
"value": "24",
"lowerLimit": "20.9",
"upperLimit": "28.3"
}
]
}
]
}
],
"analyses": [
{
"groupIds": ["OG000", "OG001"],
"nonInferiorityType": "SUPERIORITY",
"pValue": "0.010",
"statisticalMethod": "Barnard's Exact Test"
}
]
},
{
"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.",
"populationDescription": "The intent-to-treat (ITT) population includes all participants who were randomized",
"reportingStatus": "POSTED",
"paramType": "NUMBER",
"dispersionType": "95% Confidence Interval",
"unitOfMeasure": "percentage of participants",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "521"
},
{
"groupId": "OG001",
"value": "541"
}
]
}
],
"classes": [
{
"title": "Discontinued due to discharge",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "30",
"lowerLimit": "26",
"upperLimit": "34"
},
{
"groupId": "OG001",
"value": "41",
"lowerLimit": "37",
"upperLimit": "45"
}
]
}
]
},
{
"title": "Discontinued due to death",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "4",
"lowerLimit": "2",
"upperLimit": "6"
},
{
"groupId": "OG001",
"value": "3",
"lowerLimit": "2",
"upperLimit": "5"
}
]
}
]
},
{
"title": "Any infusions halted or slowed",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "2",
"lowerLimit": "1",
"upperLimit": "4"
},
{
"groupId": "OG001",
"value": "2",
"lowerLimit": "1",
"upperLimit": "4"
}
]
}
]
},
{
"title": "Missed any maintenance dose",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "21",
"lowerLimit": "18",
"upperLimit": "25"
},
{
"groupId": "OG001",
"value": "16",
"lowerLimit": "13",
"upperLimit": "19"
}
]
}
]
}
]
},
{
"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.",
"populationDescription": "The intent-to-treat (ITT) population includes all participants who were randomized",
"reportingStatus": "POSTED",
"paramType": "MEDIAN",
"dispersionType": "Inter-Quartile Range",
"unitOfMeasure": "Days",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "521"
},
{
"groupId": "OG001",
"value": "541"
}
]
}
],
"classes": [
{
"title": "Including imputation for participants who died",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "521"
},
{
"groupId": "OG001",
"value": "541"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "17",
"lowerLimit": "8",
"upperLimit": "28"
},
{
"groupId": "OG001",
"value": "12",
"lowerLimit": "6",
"upperLimit": "28"
}
]
}
]
},
{
"title": "Restricted to participants who did not die",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "443"
},
{
"groupId": "OG001",
"value": "480"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "14",
"lowerLimit": "7",
"upperLimit": "27"
},
{
"groupId": "OG001",
"value": "10",
"lowerLimit": "5",
"upperLimit": "21"
}
]
}
]
}
]
},
{
"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",
"populationDescription": "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.",
"reportingStatus": "POSTED",
"paramType": "MEDIAN",
"dispersionType": "Inter-Quartile Range",
"unitOfMeasure": "Days",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "64"
},
{
"groupId": "OG001",
"value": "52"
}
]
}
],
"classes": [
{
"title": "Including imputations for participants who died",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "64"
},
{
"groupId": "OG001",
"value": "52"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "4",
"lowerLimit": "2",
"upperLimit": "23.5"
},
{
"groupId": "OG001",
"value": "3",
"lowerLimit": "1",
"upperLimit": "10.5"
}
]
}
]
},
{
"title": "Among participants who did not die",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "50"
},
{
"groupId": "OG001",
"value": "43"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "3",
"lowerLimit": "2",
"upperLimit": "6"
},
{
"groupId": "OG001",
"value": "3",
"lowerLimit": "1",
"upperLimit": "6"
}
]
}
]
}
]
},
{
"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\n\n.",
"populationDescription": "The analysis population is restricted to randomized participants who were not on oxygen at baseline but who subsequently required oxygen.",
"reportingStatus": "POSTED",
"paramType": "MEDIAN",
"dispersionType": "Inter-Quartile Range",
"unitOfMeasure": "Days",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "28"
},
{
"groupId": "OG001",
"value": "27"
}
]
}
],
"classes": [
{
"title": "Including imputations for participants who died",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "28"
},
{
"groupId": "OG001",
"value": "27"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "5.5",
"lowerLimit": "1",
"upperLimit": "15"
},
{
"groupId": "OG001",
"value": "4",
"lowerLimit": "2",
"upperLimit": "12"
}
]
}
]
},
{
"title": "Among participants who did not die",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "25"
},
{
"groupId": "OG001",
"value": "24"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "3",
"lowerLimit": "1",
"upperLimit": "13"
},
{
"groupId": "OG001",
"value": "3.5",
"lowerLimit": "2",
"upperLimit": "5.5"
}
]
}
]
}
]
},
{
"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",
"populationDescription": "The analysis population is restricted to randomized participants not on a ventilator or ECMO at baseline but who subsequently required a ventilator or ECMO.",
"reportingStatus": "POSTED",
"paramType": "MEDIAN",
"dispersionType": "Inter-Quartile Range",
"unitOfMeasure": "Days",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "82"
},
{
"groupId": "OG001",
"value": "52"
}
]
}
],
"classes": [
{
"title": "Including imputations for participants who died",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "82"
},
{
"groupId": "OG001",
"value": "52"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "23",
"lowerLimit": "12",
"upperLimit": "28"
},
{
"groupId": "OG001",
"value": "21.5",
"lowerLimit": "9",
"upperLimit": "28"
}
]
}
]
},
{
"title": "Among participants who did not die",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "57"
},
{
"groupId": "OG001",
"value": "39"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "16",
"lowerLimit": "9",
"upperLimit": "24"
},
{
"groupId": "OG001",
"value": "14",
"lowerLimit": "5",
"upperLimit": "26"
}
]
}
]
}
]
},
{
"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.",
"populationDescription": "The analysis population is restricted to randomized participants who were not on non-invasive or high-flow oxygen at baseline.",
"reportingStatus": "POSTED",
"paramType": "NUMBER",
"dispersionType": "95% Confidence Interval",
"unitOfMeasure": "percentage of participants",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "266"
},
{
"groupId": "OG001",
"value": "307"
}
]
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "24",
"lowerLimit": "19",
"upperLimit": "30"
},
{
"groupId": "OG001",
"value": "17",
"lowerLimit": "13",
"upperLimit": "22"
}
]
}
]
}
]
},
{
"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",
"populationDescription": "The analysis population is restricted to randomized participants not requiring oxygen at baseline.",
"reportingStatus": "POSTED",
"paramType": "NUMBER",
"dispersionType": "95% Confidence Interval",
"unitOfMeasure": "percentage of participants",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "63"
},
{
"groupId": "OG001",
"value": "75"
}
]
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "44",
"lowerLimit": "33",
"upperLimit": "57"
},
{
"groupId": "OG001",
"value": "36",
"lowerLimit": "26",
"upperLimit": "47"
}
]
}
]
}
]
},
{
"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",
"populationDescription": "The analysis population is restricted to randomized participants not on a ventilator or ECMO at baseline.",
"reportingStatus": "POSTED",
"paramType": "NUMBER",
"dispersionType": "95% Confidence Interval",
"unitOfMeasure": "percentage of participants",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "364"
},
{
"groupId": "OG001",
"value": "402"
}
]
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "23",
"lowerLimit": "19",
"upperLimit": "27"
},
{
"groupId": "OG001",
"value": "13",
"lowerLimit": "10",
"upperLimit": "17"
}
]
}
]
}
]
},
{
"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.",
"populationDescription": "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.",
"reportingStatus": "POSTED",
"paramType": "MEAN",
"dispersionType": "Standard Deviation",
"unitOfMeasure": "units on a scale",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "518"
},
{
"groupId": "OG001",
"value": "533"
}
]
}
],
"classes": [
{
"title": "Day 3",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.2",
"spread": "0.6"
},
{
"groupId": "OG001",
"value": "0.1",
"spread": "0.6"
}
]
}
]
},
{
"title": "Day 5",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.1",
"spread": "0.9"
},
{
"groupId": "OG001",
"value": "0.0",
"spread": "0.8"
}
]
}
]
},
{
"title": "Day 8",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.0",
"spread": "0.1"
},
{
"groupId": "OG001",
"value": "-0.2",
"spread": "1.0"
}
]
}
]
},
{
"title": "Day 11",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "-0.1",
"spread": "1.3"
},
{
"groupId": "OG001",
"value": "-0.3",
"spread": "1.1"
}
]
}
]
},
{
"title": "Day 15",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "-1.4",
"spread": "2.3"
},
{
"groupId": "OG001",
"value": "-1.9",
"spread": "2.1"
}
]
}
]
},
{
"title": "Day 22",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "-1.9",
"spread": "2.5"
},
{
"groupId": "OG001",
"value": "-2.4",
"spread": "2.2"
}
]
}
]
},
{
"title": "Day 29",
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "-2.3",
"spread": "2.6"
},
{
"groupId": "OG001",
"value": "-2.7",
"spread": "2.3"
}
]
}
]
}
]
},
{
"type": "SECONDARY",
"title": "14-day Participant Mortality",
"description": "The mortality rate was determined as the proportion of participants who died by study Day 15.",
"populationDescription": "The ITT population consists of all participants as randomized.",
"reportingStatus": "POSTED",
"paramType": "NUMBER",
"dispersionType": "95% Confidence Interval",
"unitOfMeasure": "Proportion of participants",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "521"
},
{
"groupId": "OG001",
"value": "541"
}
]
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.12",
"lowerLimit": "0.09",
"upperLimit": "0.15"
},
{
"groupId": "OG001",
"value": "0.07",
"lowerLimit": "0.05",
"upperLimit": "0.09"
}
]
}
]
}
]
},
{
"type": "SECONDARY",
"title": "29-day Participant Mortality",
"description": "The mortality rate was determined as the proportion of participants who died by study Day 29.",
"populationDescription": "The ITT population includes all participants as randomized",
"reportingStatus": "POSTED",
"paramType": "NUMBER",
"dispersionType": "95% Confidence Interval",
"unitOfMeasure": "Proportion of participants",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "521"
},
{
"groupId": "OG001",
"value": "541"
}
]
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0.15",
"lowerLimit": "0.12",
"upperLimit": "0.19"
},
{
"groupId": "OG001",
"value": "0.11",
"lowerLimit": "0.09",
"upperLimit": "0.15"
}
]
}
]
}
]
},
{
"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",
"populationDescription": "The ITT population includes all participants as randomized",
"reportingStatus": "POSTED",
"paramType": "MEDIAN",
"dispersionType": "95% Confidence Interval",
"unitOfMeasure": "Days",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "521"
},
{
"groupId": "OG001",
"value": "541"
}
]
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "9",
"lowerLimit": "8",
"upperLimit": "11"
},
{
"groupId": "OG001",
"value": "7",
"lowerLimit": "6",
"upperLimit": "8"
}
]
}
]
}
],
"analyses": [
{
"groupIds": ["OG000", "OG001"],
"nonInferiorityType": "SUPERIORITY",
"pValue": "0.002",
"statisticalMethod": "Log Rank",
"paramType": "Cox Proportional Hazard",
"paramValue": "1.23",
"ciPctValue": "95",
"ciNumSides": "TWO_SIDED",
"ciLowerLimit": "1.08",
"ciUpperLimit": "1.41"
}
]
},
{
"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",
"populationDescription": "The ITT population includes all participants as randomized",
"reportingStatus": "POSTED",
"paramType": "MEDIAN",
"dispersionType": "95% Confidence Interval",
"unitOfMeasure": "Days",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "521"
},
{
"groupId": "OG001",
"value": "541"
}
]
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "14",
"lowerLimit": "13",
"upperLimit": "15"
},
{
"groupId": "OG001",
"value": "11",
"lowerLimit": "10",
"upperLimit": "13"
}
]
}
]
}
],
"analyses": [
{
"groupIds": ["OG000", "OG001"],
"nonInferiorityType": "SUPERIORITY",
"pValue": "<0.001",
"statisticalMethod": "Log Rank",
"paramType": "Cox Proportional Hazard",
"paramValue": "1.29",
"ciPctValue": "95",
"ciNumSides": "TWO_SIDED",
"ciLowerLimit": "1.12",
"ciUpperLimit": "1.48"
}
]
},
{
"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.",
"populationDescription": "The ITT population includes all participants as randomized.",
"reportingStatus": "POSTED",
"paramType": "MEDIAN",
"dispersionType": "95% Confidence Interval",
"unitOfMeasure": "Days",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "521"
},
{
"groupId": "OG001",
"value": "541"
}
]
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "12",
"lowerLimit": "10",
"upperLimit": "15"
},
{
"groupId": "OG001",
"value": "8",
"lowerLimit": "7",
"upperLimit": "9"
}
]
}
]
}
],
"analyses": [
{
"groupIds": ["OG000", "OG001"],
"nonInferiorityType": "SUPERIORITY",
"pValue": "<0.001",
"statisticalMethod": "Log Rank",
"paramType": "Cox Proportional Hazard",
"paramValue": "1.27",
"ciPctValue": "95",
"ciNumSides": "TWO_SIDED",
"ciLowerLimit": "1.10",
"ciUpperLimit": "1.46"
}
]
},
{
"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.",
"populationDescription": "The intent-to-treat (ITT) population includes all participants who were randomized",
"reportingStatus": "POSTED",
"paramType": "MEDIAN",
"dispersionType": "95% Confidence Interval",
"unitOfMeasure": "Days",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "521"
},
{
"groupId": "OG001",
"value": "541"
}
]
}
],
"classes": [
{
"title": "Asian",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "56"
},
{
"groupId": "OG001",
"value": "79"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "12.0",
"lowerLimit": "9.0",
"upperLimit": "15.0"
},
{
"groupId": "OG001",
"value": "11.0",
"lowerLimit": "9.0",
"upperLimit": "15.0"
}
]
}
]
},
{
"title": "Black or African American",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "117"
},
{
"groupId": "OG001",
"value": "109"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "15.0",
"lowerLimit": "10.0",
"upperLimit": "21.0"
},
{
"groupId": "OG001",
"value": "10.0",
"lowerLimit": "7.0",
"upperLimit": "16.0"
}
]
}
]
},
{
"title": "White",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "287"
},
{
"groupId": "OG001",
"value": "279"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "15.0",
"lowerLimit": "12.0",
"upperLimit": "19.0"
},
{
"groupId": "OG001",
"value": "9.0",
"lowerLimit": "8.0",
"upperLimit": "12.0"
}
]
}
]
},
{
"title": "Other",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "61"
},
{
"groupId": "OG001",
"value": "74"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "24.0",
"lowerLimit": "15.0",
"upperLimit": "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."
},
{
"groupId": "OG001",
"value": "9.0",
"lowerLimit": "6.0",
"upperLimit": "14.0"
}
]
}
]
}
],
"analyses": [
{
"groupIds": ["OG000", "OG001"],
"groupDescription": "This analysis is for Asian participants",
"nonInferiorityType": "SUPERIORITY",
"paramType": "Cox Proportional Hazard",
"paramValue": "1.07",
"ciPctValue": "95",
"ciNumSides": "TWO_SIDED",
"ciLowerLimit": "0.73",
"ciUpperLimit": "1.58"
},
{
"groupIds": ["OG000", "OG001"],
"groupDescription": "This analysis is for Black or African American participants",
"nonInferiorityType": "SUPERIORITY",
"paramType": "Cox Proportional Hazard",
"paramValue": "1.25",
"ciPctValue": "95",
"ciNumSides": "TWO_SIDED",
"ciLowerLimit": "0.91",
"ciUpperLimit": "1.72"
},
{
"groupIds": ["OG000", "OG001"],
"groupDescription": "This analysis is for White participants",
"nonInferiorityType": "SUPERIORITY",
"paramType": "Cox Proportional Hazard",
"paramValue": "1.29",
"ciPctValue": "95",
"ciNumSides": "TWO_SIDED",
"ciLowerLimit": "1.06",
"ciUpperLimit": "1.57"
},
{
"groupIds": ["OG000", "OG001"],
"groupDescription": "This analysis is for Race of Other participants",
"nonInferiorityType": "SUPERIORITY",
"paramType": "Cox Proportional Hazard",
"paramValue": "1.68",
"ciPctValue": "95",
"ciNumSides": "TWO_SIDED",
"ciLowerLimit": "1.10",
"ciUpperLimit": "2.58"
}
]
},
{
"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.",
"populationDescription": "The intent-to-treat (ITT) population includes all participants who were randomized and for whom Ethnicity was reported",
"reportingStatus": "POSTED",
"paramType": "MEDIAN",
"dispersionType": "95% Confidence Interval",
"unitOfMeasure": "Days",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "489"
},
{
"groupId": "OG001",
"value": "516"
}
]
}
],
"classes": [
{
"title": "Not Hispanic or Latino",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "373"
},
{
"groupId": "OG001",
"value": "382"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "15.0",
"lowerLimit": "13.0",
"upperLimit": "18.0"
},
{
"groupId": "OG001",
"value": "10.0",
"lowerLimit": "8.0",
"upperLimit": "12.0"
}
]
}
]
},
{
"title": "Hispanic or Latino",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "116"
},
{
"groupId": "OG001",
"value": "134"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "12.5",
"lowerLimit": "9.0",
"upperLimit": "22.0"
},
{
"groupId": "OG001",
"value": "10.0",
"lowerLimit": "7.0",
"upperLimit": "14.0"
}
]
}
]
}
],
"analyses": [
{
"groupIds": ["OG000", "OG001"],
"groupDescription": "This analysis is for Not Hispanic or Latino participants",
"nonInferiorityType": "SUPERIORITY",
"paramType": "Cox Proportional Hazard",
"paramValue": "1.31",
"ciPctValue": "95",
"ciNumSides": "TWO_SIDED",
"ciLowerLimit": "1.10",
"ciUpperLimit": "1.55"
},
{
"groupIds": ["OG000", "OG001"],
"groupDescription": "This analysis is for Hispanic or Latino participants",
"nonInferiorityType": "SUPERIORITY",
"paramType": "Cox Proportional Hazard",
"paramValue": "1.28",
"ciPctValue": "95",
"ciNumSides": "TWO_SIDED",
"ciLowerLimit": "0.94",
"ciUpperLimit": "1.73"
}
]
},
{
"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.",
"populationDescription": "The intent-to-treat (ITT) population includes all participants who were randomized",
"reportingStatus": "POSTED",
"paramType": "MEDIAN",
"dispersionType": "95% Confidence Interval",
"unitOfMeasure": "Days",
"timeFrame": "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."
},
{
"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": [
{
"groupId": "OG000",
"value": "521"
},
{
"groupId": "OG001",
"value": "541"
}
]
}
],
"classes": [
{
"title": "Male",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "332"
},
{
"groupId": "OG001",
"value": "352"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "15.0",
"lowerLimit": "12.0",
"upperLimit": "19.0"
},
{
"groupId": "OG001",
"value": "9.0",
"lowerLimit": "8.0",
"upperLimit": "12.0"
}
]
}
]
},
{
"title": "Female",
"denoms": [
{
"units": "Participants",
"counts": [
{
"groupId": "OG000",
"value": "189"
},
{
"groupId": "OG001",
"value": "189"
}
]
}
],
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "15.0",
"lowerLimit": "12.0",
"upperLimit": "19.0"
},
{
"groupId": "OG001",
"value": "10.0",
"lowerLimit": "8.0",
"upperLimit": "13.0"
}
]
}
]
}
],
"analyses": [
{
"groupIds": ["OG000", "OG001"],
"groupDescription": "This analysis is for Male participants",
"nonInferiorityType": "SUPERIORITY",
"paramType": "Cox Proportional Hazard",
"paramValue": "1.30",
"ciPctValue": "95",
"ciNumSides": "TWO_SIDED",
"ciLowerLimit": "1.09",
"ciUpperLimit": "1.56"
},
{
"groupIds": ["OG000", "OG001"],
"groupDescription": "This analysis is for Female participants",
"nonInferiorityType": "SUPERIORITY",
"paramType": "Cox Proportional Hazard",
"paramValue": "1.31",
"ciPctValue": "95",
"ciNumSides": "TWO_SIDED",
"ciLowerLimit": "1.03",
"ciUpperLimit": "1.66"
}
]
}
]
},
"adverseEventsModule": {
"frequencyThreshold": "5",
"timeFrame": "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.",
"eventGroups": [
{
"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.",
"deathsNumAffected": 77,
"deathsNumAtRisk": 521,
"seriousNumAffected": 163,
"seriousNumAtRisk": 516,
"otherNumAffected": 295,
"otherNumAtRisk": 516
},
{
"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.",
"deathsNumAffected": 59,
"deathsNumAtRisk": 541,
"seriousNumAffected": 131,
"seriousNumAtRisk": 532,
"otherNumAffected": 276,
"otherNumAtRisk": 532
}
],
"seriousEvents": [
{
"term": "Coagulopathy",
"organSystem": "Blood and lymphatic system disorders",
"sourceVocabulary": "MedDRA (23.0)",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"stats": [
{
"groupId": "EG000",
"numEvents": 0,
"numAffected": 0,
"numAtRisk": 516
},
{
"groupId": "EG001",
"numEvents": 1,
"numAffected": 1,
"numAtRisk": 532
}
]
},
{
"term": "Febrile neutropenia",
"organSystem": "Blood and lymphatic system disorders",
"sourceVocabulary": "MedDRA (23.0)",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"stats": [
{
"groupId": "EG000",
"numEvents": 0,
"numAffected": 0,
"numAtRisk": 516
},
{
"groupId": "EG001",
"numEvents": 1,
"numAffected": 1,
"numAtRisk": 532
}
]
},
{
"term": "Anaemia",
"organSystem": "Blood and lymphatic system disorders",
"sourceVocabulary": "MedDRA (23.0)",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"stats": [
{
"groupId": "EG000",
"numEvents": 1,
"numAffected": 1,
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