Expanded Access Remdesivir (RDV; GS-5734™)


Study First Submitted Date 2020-03-02
Study First Posted Date 2020-03-10
Last Update Posted Date 2022-02-17
Verification Month Year February 2022
Verification Date 2022-02-28
Last Update Posted Date 2022-02-17

Detailed Descriptions

Sequence: 20759055
Description The treatment of communicable Novel Coronavirus (CODIV-19) of 2019 with Remdesivir (RDV; GS-5734™) also known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)


Sequence: 200423860 Sequence: 200423861 Sequence: 200423862 Sequence: 200423863 Sequence: 200423864 Sequence: 200423865 Sequence: 200423866 Sequence: 200423867 Sequence: 200423868 Sequence: 200423869 Sequence: 200423870 Sequence: 200423871 Sequence: 200423872 Sequence: 200423873 Sequence: 200423874 Sequence: 200423875 Sequence: 200423876 Sequence: 200423877 Sequence: 200423878 Sequence: 200423879 Sequence: 200423880 Sequence: 200423881
Name Naval Medical Center San Diego Name Naval Hospital Jacksonville Name Benning Martin Army Community Hospital Name Eisenhower Army Medical Center Name Tripler Army Medical Center Name Blanchfield Army Community Hospital Name Walter Reed National Military Medical Center Name Naval Medical Center Camp Lejeune Name Womack Army Medical Center Name William Beaumont Army Medical Center Name Carl R. Darnall Army Medical Center Name Brooke Army Medical Center Name Naval Medical Center Portsmouth Name Madigan Army Medical Center Name Craig Joint Theater Hospital Name NATO Role 3 Multinational Medical Unit Kandahar Air Field Name EMF Camp Lemonnier Name Landstuhl Regional Medical Center Name US Naval Hospital Guam Name Baghdad Diplomatic Support Center Name US Naval Hospital Okinawa Name US Military Hospital Kuwait 411th Hospital Center
City San Diego City Jacksonville City Fort Benning City Fort Gordon City Tripler AMC City Fort Campbell North City Bethesda City Camp Lejeune City Fort Bragg City El Paso City Fort Hood City Fort Sam Houston City Portsmouth City Tacoma City Bagrām City Kandahar City Djibouti City Landstuhl City Agaña City Baghdad City Okinawa City Kuwait
State California State Florida State Georgia State Georgia State Hawaii State Kentucky State Maryland State North Carolina State North Carolina State Texas State Texas State Texas State Virginia State Washington State APO Ae
Zip 92134-5000 Zip 32214-5005 Zip 31905 Zip 30905-5741 Zip 96859-5000 Zip 42223-5318 Zip 20889-0001 Zip 28547-2538 Zip 28310-7324 Zip 79920-5001 Zip 76544-5095 Zip 78234-4504 Zip 23708-2197 Zip 98431-0001 Zip 09354 Zip 09180 Zip 96910 Zip 09305 Zip 904-0103 Zip 09366-9998
Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country Afghanistan Country Afghanistan Country Djibouti Country Germany Country Guam Country Iraq Country Japan Country Kuwait

Browse Interventions

Sequence: 96205231 Sequence: 96205232 Sequence: 96205233 Sequence: 96205234 Sequence: 96205235
Mesh Term Remdesivir Mesh Term Antimetabolites Mesh Term Molecular Mechanisms of Pharmacological Action Mesh Term Antiviral Agents Mesh Term Anti-Infective Agents
Downcase Mesh Term remdesivir Downcase Mesh Term antimetabolites Downcase Mesh Term molecular mechanisms of pharmacological action Downcase Mesh Term antiviral agents Downcase Mesh Term anti-infective agents
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor


Sequence: 52267332
Name Coronavirus Disease 2019
Downcase Name coronavirus disease 2019

Id Information

Sequence: 40228412
Id Source org_study_id
Id Value S-20-01


Sequence: 42644999 Sequence: 42645000 Sequence: 42645001 Sequence: 42645002 Sequence: 42645003 Sequence: 42645004 Sequence: 42645005 Sequence: 42645006
Name United States Name Afghanistan Name Djibouti Name Germany Name Guam Name Iraq Name Japan Name Kuwait
Removed False Removed False Removed False Removed False Removed False Removed False Removed False Removed False


Sequence: 52579897
Intervention Type Drug
Name Remdesivir
Description Remdesivir (RDV,GS-5734) is a monophosphoramidate prodrug of an adenosine analog with potent activity against an array of RNA virus families including Filoviridae, Paramyxoviridae, Pneumoviridae, and Orthocoronavirinae, through the targeting of the viral RNA dependent RNA polymerase (RdRp).


Sequence: 80005371 Sequence: 80005372 Sequence: 80005373 Sequence: 80005374
Name COVID-19 Name GS-5734 Name Remdesivir Name SARS-CoV-2
Downcase Name covid-19 Downcase Name gs-5734 Downcase Name remdesivir Downcase Name sars-cov-2

Browse Conditions

Sequence: 193854066 Sequence: 193854065 Sequence: 193854067 Sequence: 193854068 Sequence: 193854069 Sequence: 193854070 Sequence: 193854071 Sequence: 193854072 Sequence: 193854073 Sequence: 193854074 Sequence: 193854075 Sequence: 193854076
Mesh Term COVID-19 Mesh Term Coronavirus Infections Mesh Term Coronaviridae Infections Mesh Term Nidovirales Infections Mesh Term RNA Virus Infections Mesh Term Virus Diseases Mesh Term Infections Mesh Term Pneumonia, Viral Mesh Term Pneumonia Mesh Term Respiratory Tract Infections Mesh Term Lung Diseases Mesh Term Respiratory Tract Diseases
Downcase Mesh Term covid-19 Downcase Mesh Term coronavirus infections Downcase Mesh Term coronaviridae infections Downcase Mesh Term nidovirales infections Downcase Mesh Term rna virus infections Downcase Mesh Term virus diseases Downcase Mesh Term infections Downcase Mesh Term pneumonia, viral Downcase Mesh Term pneumonia Downcase Mesh Term respiratory tract infections Downcase Mesh Term lung diseases Downcase Mesh Term respiratory tract diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor


Sequence: 48409019
Agency Class FED
Lead Or Collaborator lead
Name U.S. Army Medical Research and Development Command


Sequence: 30821218
Gender All
Minimum Age N/A
Maximum Age N/A
Criteria Inclusion Criteria: DoD-affiliated personnel as defined in DoDI 6200.02, which includes emergency-essential civilian employees and/or contractor personnel accompanying the Armed Forces who are subject to the same health risk as military personnel Have a laboratory-confirmed COVID-19 diagnosis with moderate to severe disease presentation as determined by the principal investigator Patient or legally authorized representative (LAR) provides written informed consent, except as noted in 21 CFR 50.23 Understands and agrees to comply with planned study procedures Available for clinical follow-up for duration of the treatment and follow-up period Woman of childbearing potential must Have a negative pregnancy test within 24 hours before starting treatment Agree not to become pregnant during treatment and for 1 months after receiving remdesivir (Treatment will be a maximum of 10 doses given over a 10-day interval) Use at least 2 reliable forms of effective contraception, including 1 barrier method, during treatment and for 1 month after the treatment period Exclusion Criteria: ALT/AST ≥ 5 times the upper limit of normal Stage 4 severe kidney disease or requiring dialysis (i.e. eGFR <30) Anticipated transfer to another hospital that is not a study site within 72 hours Allergy to any components of the study medication [GS-5734, sulfobutylether β-cyclodextrin sodium (SBECD) and hydrochloric acid and/or sodium hydroxide] Concomitant antiviral therapy (lopinavir/ritonavir [Kaletra]) Pregnant or nursing
Adult True
Child True
Older Adult True

Calculated Values

Sequence: 254109091
Number Of Facilities 22
Registered In Calendar Year 2020
Were Results Reported False
Has Us Facility True
Has Single Facility False

Intervention Other Names

Sequence: 26718381
Intervention Id 52579897
Name GS-5734

Provided Documents

Sequence: 2588480
Document Type Informed Consent Form
Has Protocol False
Has Icf True
Has Sap False
Document Date 2020-06-23
Url https://ClinicalTrials.gov/ProvidedDocs/66/NCT04302766/ICF_000.pdf

Responsible Parties

Sequence: 28933559
Responsible Party Type Sponsor