Last Verified: | March/31/2020 |
First Submitted: | March/1/2020 |
Estimated Enrollment Submitted: | March/5/2020 |
First Posted: | March/9/2020 |
Last Update Submitted: | April/7/2020 |
Last Update Posted: | April/9/2020 |
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 |