Expanded Access Remdesivir (RDV; GS-5734™)

NO_LONGER_AVAILABLE

Conditions studied: Coronavirus Disease 2019

In brief

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

Key facts

Study ID

NCT04302766

Run by

U.S. Army Medical Research and Development Command

Last updated by the study team

2022-02-17

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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
• Walter Reed National Military Medical Center — Bethesda, Maryland, United States
• Womack Army Medical Center — Fort Bragg, North Carolina, United States
• Naval Medical Center Camp Lejeune — Marine Corps Base Camp Lejeune, 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
• Brooke Army Medical Center — Fort Sam Houston, Texas, United States
• Naval Medical Center Portsmouth — Portsmouth, Virginia, United States
• Madigan Army Medical Center — Tacoma, Washington, United States
• Craig Joint Theater Hospital — Bagrām, Afghanistan
• 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 — Hagåtña, Guam
• Baghdad Diplomatic Support Center — Baghdad, Iraq
• US Naval Hospital Okinawa — Okinawa, Japan
• US Military Hospital Kuwait 411th Hospital Center — Kuwait City, Kuwait

Full record on ClinicalTrials.gov

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