Expanded Access Remdesivir (RDV; GS-5734™)
Status:
Available
Sponsors
U.S. Army Medical Research and Development Command
Abstract:
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)
Condition or disease:Coronavirus Disease 2019
Intervention/treatment:
Drug:
Phase:-
Eligibility Criteria:
Sexes Eligible for Study:All
Accepts Healthy Volunteers:No
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

Relations:
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