Expanded Access Remdesivir (RDV; GS-5734™)

Coronavirus Disease 2019 Clinical Trial

Official title:

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

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT04302766
• Other study ID #: S-20-01
• Status: No longer available

Study information

• Verified date: February 2022
• Source: U.S. Army Medical Research and Development Command
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial Summary

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

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 information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: All
• Age group: N/A and older

Eligibility

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 ß-cyclodextrin sodium (SBECD) and hydrochloric acid and/or sodium hydroxide]
• Concomitant antiviral therapy (lopinavir/ritonavir [Kaletra])
• Pregnant or nursing

Related Conditions & MeSH terms

• Coronavirus Disease 2019
• Coronavirus Infections
• COVID-19

Intervention

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).

Locations

Country	Name	City	State
Afghanistan	Craig Joint Theater Hospital	Bagram
Afghanistan	NATO Role 3 Multinational Medical Unit Kandahar Air Field	Kandahar
Djibouti	EMF Camp Lemonnier	Djibouti
Germany	Landstuhl Regional Medical Center	Landstuhl	APO Ae
Guam	US Naval Hospital Guam	Agaña
Iraq	Baghdad Diplomatic Support Center	Baghdad
Japan	US Naval Hospital Okinawa	Okinawa
Kuwait	US Military Hospital Kuwait 411th Hospital Center	Kuwait
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	Naval Medical Center Camp Lejeune	Camp Lejeune	North Carolina
United States	William Beaumont Army Medical Center	El Paso	Texas
United States	Benning Martin Army Community Hospital	Fort Benning	Georgia
United States	Womack Army Medical Center	Fort Bragg	North Carolina
United States	Blanchfield Army Community Hospital	Fort Campbell North	Kentucky
United States	Eisenhower Army Medical Center	Fort Gordon	Georgia
United States	Carl R. Darnall Army Medical Center	Fort Hood	Texas
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	Naval Hospital Jacksonville	Jacksonville	Florida
United States	Naval Medical Center Portsmouth	Portsmouth	Virginia
United States	Naval Medical Center San Diego	San Diego	California
United States	Madigan Army Medical Center	Tacoma	Washington
United States	Tripler Army Medical Center	Tripler AMC	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
U.S. Army Medical Research and Development Command

Countries where clinical trial is conducted

United States,  Afghanistan,  Djibouti,  Germany,  Guam,  Iraq,  Japan,  Kuwait,