ClinicalTrials.gg
No longer availableNCT04302766Updated Feb 17, 2022

Expanded Access Remdesivir (RDV; GS-5734™)

An expanded access record providing Remdesivir in Coronavirus Disease 2019, sponsored by U.S. Army Medical Research and Development Command. No longer available at 22 sites in 8 countries. Per ClinicalTrials.gov, last updated 2022-02-17.

Sponsored by U.S. Army Medical Research and Development Command · Expanded access

Study type
Expanded access
Access type
Intermediate-size population · Treatment IND/protocol
Sex
All
01

Study summary

Disease caused by 2019 Novel Coronavirus also known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

Read the detailed 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)

02

Conditions studied

  • Coronavirus Disease 2019

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Keywords

  • COVID-19
  • GS-5734
  • Remdesivir
  • SARS-CoV-2
03

In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

Browse COVID-19 studies →

Lead sponsor

U.S. Army Medical Research and Development Command is the lead sponsor of 153 studies on the registry; 8 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 , 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 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 , including 1 barrier method, during treatment and for 1 month after the treatment period

Exclusion criteria

Exclusion Criteria:

  • /AST ≥ 5 times the
  • Stage 4 severe kidney disease or requiring dialysis (i.e. \<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
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Access details

Study type
Expanded access
Access type
Intermediate-size population · Treatment IND/protocol

Available treatment

  • 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).

    Also known as: GS-5734

06

Where to request access

22 sites
  • Naval Medical Center San Diego
    San Diego, California 92134-5000, United States
  • Naval Hospital Jacksonville
    Jacksonville, Florida 32214-5005, United States
  • Benning Martin Army Community Hospital
    Fort Benning, Georgia 31905, United States
  • Eisenhower Army Medical Center
    Fort Gordon, Georgia 30905-5741, United States
  • Tripler Army Medical Center
    Tripler AMC, Hawaii 96859-5000, United States
  • Blanchfield Army Community Hospital
    Fort Campbell North, Kentucky 42223-5318, United States
  • Walter Reed National Military Medical Center
    Bethesda, Maryland 20889-0001, United States
  • Naval Medical Center Camp Lejeune
    Camp Lejeune, North Carolina 28547-2538, United States
  • Womack Army Medical Center
    Fort Bragg, North Carolina 28310-7324, United States
  • William Beaumont Army Medical Center
    El Paso, Texas 79920-5001, United States
  • Carl R. Darnall Army Medical Center
    Fort Hood, Texas 76544-5095, United States
  • Brooke Army Medical Center
    Fort Sam Houston, Texas 78234-4504, United States
  • Naval Medical Center Portsmouth
    Portsmouth, Virginia 23708-2197, United States
  • Madigan Army Medical Center
    Tacoma, Washington 98431-0001, United States
  • Craig Joint Theater Hospital
    Bagrām, 09354, Afghanistan
  • NATO Role 3 Multinational Medical Unit Kandahar Air Field
    Kandahar, Afghanistan
  • EMF Camp Lemonnier
    Djibouti, Djibouti
  • Landstuhl Regional Medical Center
    Landstuhl, APO Ae 09180, Germany
  • US Naval Hospital Guam
    Agaña, 96910, Guam
  • Baghdad Diplomatic Support Center
    Baghdad, 09305, Iraq
  • US Naval Hospital Okinawa
    Okinawa, 904-0103, Japan
  • US Military Hospital Kuwait 411th Hospital Center
    Kuwait, 09366-9998, Kuwait
07

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04302766
Responsible party
Sponsor
First posted
Mar 10, 2020
Last update
Feb 17, 2022
View the source record on ClinicalTrials.gov ↗

Requesting access

Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.

No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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