Expanded Access Remdesivir (RDV; GS-5734™)
- Conditions
- Coronavirus Disease 2019
- Registration Number
- NCT04302766
- Lead Sponsor
- U.S. Army Medical Research and Development Command
- Brief Summary
Disease caused by 2019 Novel Coronavirus also known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
- 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)
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
-
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
- 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
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (22)
Naval Medical Center San Diego
🇺🇸San Diego, California, United States
Naval Hospital Jacksonville
🇺🇸Jacksonville, Florida, United States
Benning Martin Army Community Hospital
🇺🇸Fort Benning, Georgia, United States
Eisenhower Army Medical Center
🇺🇸Fort Gordon, Georgia, United States
Tripler Army Medical Center
🇺🇸Tripler AMC, Hawaii, United States
Blanchfield Army Community Hospital
🇺🇸Fort Campbell North, Kentucky, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
Walter Reed National Military Medical Center
🇺🇸Bethesda, Maryland, United States
Womack Army Medical Center
🇺🇸Fort Bragg, North Carolina, United States
William Beaumont Army Medical Center
🇺🇸El Paso, Texas, United States
Carl R. Darnall Army Medical Center
🇺🇸Fort Hood, Texas, United States
Naval Medical Center Camp Lejeune
🇺🇸Camp Lejeune, North Carolina, United States
Naval Medical Center Portsmouth
🇺🇸Portsmouth, Virginia, United States
Craig Joint Theater Hospital
🇦🇫Bagrām, Afghanistan
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
NATO Role 3 Multinational Medical Unit Kandahar Air Field
🇦🇫Kandahar, Afghanistan
EMF Camp Lemonnier
🇩🇯Djibouti, Djibouti
Landstuhl Regional Medical Center
🇩🇪Landstuhl, APO Ae, Germany
US Naval Hospital Guam
🇬🇺Agaña, Guam
Baghdad Diplomatic Support Center
🇮🇶Baghdad, Iraq
US Naval Hospital Okinawa
🇯🇵Okinawa, Japan
US Military Hospital Kuwait 411th Hospital Center
🇰🇼Kuwait, Kuwait