Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
U.S. Army Medical Research and Development Command
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)
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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 \[GS-5734, sulfobutylether β-cyclodextrin sodium (SBECD) and hydrochloric acid and/or sodium hydroxide\]
