Intermediate-Size Patient Population Expanded Access Treatment Protocol for Coronavirus Disease 2019 (COVID-19) Remdesivir (RDV; GS-5734™)
Latest Information Update: 04 Nov 2021
At a glance
- Drugs Remdesivir (Primary)
- Indications COVID 2019 infections; SARS-CoV-2 acute respiratory disease
- Focus Expanded access; Therapeutic Use
- 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
Most Recent Events
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 | - |
Biomarker
NCT Number | Biomarker Name | Biomarker Function |
---|---|---|
NCT04302766 | protein tyrosine phosphatase, receptor type F | Eligibility Criteria |
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 |
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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 |
01 Apr 2021 | Biomarker Update | Biomarkers information updated Updated 04 Nov 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
-
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
Food and Drug Administration. Coronavirus (COVID-19) Update: FDA Continues to Facilitate Development of Treatments. Media-Rel 2020;.
Media Release
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