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Intermediate-Size Patient Population Expanded Access Treatment Protocol for Coronavirus Disease 2019 (COVID-19) Remdesivir (RDV; GS-5734™)

Trial Profile

Intermediate-Size Patient Population Expanded Access Treatment Protocol for Coronavirus Disease 2019 (COVID-19) Remdesivir (RDV; GS-5734™)

Status: Completed
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 06 Apr 2021

At a glance

  • Drugs Remdesivir (Primary)
  • Indications COVID 2019 infections; SARS-CoV-2 acute respiratory disease
  • Focus Expanded access; Therapeutic Use
  • Most Recent Events

    • 05 Mar 2021 Status changed from recruiting to completed.
    • 19 Mar 2020 The U.S. Food and Drug Administration media release,to date, the agency has already granted about 250 patients access to this product.
    • 12 Mar 2020 New trial record

Trial Overview

Purpose

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)

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -
SARS-CoV-2 acute respiratory disease treatment -

Subjects

  • Subject Type patients
  • Sex male & female
  • Age Group ≥ 18 years; Adult

Patient 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

Patient 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

Trial Details

Identifiers

Identifier Owner
NCT04302766 ClinicalTrials.gov: US National Institutes of Health
S20-01 -

Trial Dates

Other Details

  • Design multicentre; prospective
  • Phase of Trial Clinical Phase Unknown
  • Location Afghanistan; Djibouti; Germany; Guam; Iraq; Japan; Kuwait; USA
  • Focus Expanded access; Therapeutic Use

Interventions

Drugs Route Formulation
RemdesivirPrimary Drug Intravenous Injection

Drug: Remdesivir (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).) Other Name: GS-5734

Trial Centres

Centres

Centre Name Location Trial Centre Country
Baghdad Diplomatic Support Center Baghdad Iraq
Benning Martin Army Community Hospital Fort Benning, Georgia USA
Blanchfield Army Community Hospital Fort Campbell North, Kentucky USA
Brooke Army Medical Center Fort Sam Houston, Texas USA
Carl R. Darnall Army Medical Center Fort Hood, Texas USA
Craig Joint Theater Hospital Bagrām Afghanistan
Eisenhower Army Medical Center Fort Gordon, Georgia USA
EMF Camp Lemonnier Djibouti Djibouti
Landstuhl Regional Medical Center Landstuhl, APO Ae Germany
Madigan Army Medical Center Tacoma, Washington USA
NATO Role 3 Multinational Medical Unit Kandahar Air Field Kandahar Afghanistan
Naval Hospital Jacksonville Jacksonville, Florida USA
Naval Medical Center Camp Lejeune Camp Lejeune, North Carolina USA
Naval Medical Center Portsmouth Portsmouth, Virginia USA
Naval Medical Center San Diego San Diego, California USA
Tripler Army Medical Center Tripler AMC, Hawaii USA
U.S. Army Medical Research and Development Command
-
-
US Military Hospital Kuwait 411th Hospital Center Kuwait Kuwait
US Naval Hospital Guam Agaña Guam
US Naval Hospital Okinawa Okinawa Japan
Walter Reed National Military Medical Center Bethesda, Maryland USA
William Beaumont Army Medical Center El Paso, Texas USA
Womack Army Medical Center Fort Bragg, North Carolina USA

Trial History

Event Date Event Type Comment
06 Apr 2021 Other trial event Last checked against Clinicaltrials.gov record. Updated 06 Apr 2021
05 Mar 2021 Status change - completed Status changed from recruiting to completed. Updated 15 Mar 2021
19 Mar 2020 Other trial event The U.S. Food and Drug Administration media release,to date, the agency has already granted about 250 patients access to this product. Updated 20 Mar 2020
12 Mar 2020 New trial record New trial record Updated 12 Mar 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. Food and Drug Administration. Coronavirus (COVID-19) Update: FDA Continues to Facilitate Development of Treatments. Media-Rel 2020;.

    Media Release
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