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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).
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Layout table for eligibility information
Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
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
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]