Expanded Access Remdesivir (RDV; GS-5734™)

Status:

NO_LONGER_AVAILABLE

Expanded Access Remdesivir (RDV; GS-5734™)

Lead Sponsor:

U.S. Army Medical Research and Development Command

Conditions:

Coronavirus Disease 2019

Eligibility:

All Genders

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)

Eligibility Criteria

Inclusion

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

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

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04302766

Last Update

February 17 2022

Active Locations (22)

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Page 1 of 6 (22 locations)

Naval Medical Center San Diego

San Diego, California, United States, 92134-5000

Naval Hospital Jacksonville

Jacksonville, Florida, United States, 32214-5005

Benning Martin Army Community Hospital

Fort Benning, Georgia, United States, 31905