Expanded Access Remdesivir (RDV; GS-5734™)
Intermediate-Size Patient Population Expanded Access Treatment Protocol for Coronavirus Disease 2019 (COVID-19) Remdesivir (RDV; GS-5734™)
1 other identifier
expanded_access
N/A
8 countries
22
Brief Summary
Disease caused by 2019 Novel Coronavirus also known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2020
CompletedFirst Posted
Study publicly available on registry
March 10, 2020
CompletedFebruary 17, 2022
February 1, 2022
March 2, 2020
February 15, 2022
Conditions
Keywords
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
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
Womack Army Medical Center
Fort Bragg, North Carolina, 28310-7324, United States
Naval Medical Center Camp Lejeune
Marine Corps Base Camp Lejeune, North Carolina, 28547-2538, 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
Hagåtña, 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 City, 09366-9998, Kuwait