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

No longer available
Intermediate-size Population
Treatment IND/Protocol
Coronavirus Disease 2019

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

Eligibility Criteria

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

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

Eligibility Gender
Eligibility Age
Minimum: N/A ~ Maximum: N/A
United States

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

Naval Medical Center Camp Lejeune
Camp Lejeune, North Carolina, 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

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
Agaña, Guam

Baghdad Diplomatic Support Center
Baghdad, Iraq

US Naval Hospital Okinawa
Okinawa, Japan

US Military Hospital Kuwait 411th Hospital Center
Kuwait, Kuwait

U.S. Army Medical Research and Development Command
NCT Number
MeSH Terms
Coronavirus Infections