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

U.S. Army Medical Research and Development Command22 sites in 8 countriesMarch 10, 2020

ConditionsCoronavirus Disease 2019

DrugsRemdesivir

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronavirus Disease 2019
Sponsor: U.S. Army Medical Research and Development Command
Locations: 22
Status: No Longer Available
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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)

Registry

clinicaltrials.gov

Start Date

March 10, 2020

End Date

TBD

Last Updated

4 years ago

Study Type

Expanded Access

Sex

All

Investigators

Sponsor

U.S. Army Medical Research and Development Command

Responsible Party

Sponsor

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