Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-24 @ 4:34 PM
NCT ID:
NCT04302766
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
Sex:
ALL
Study:
NCT04302766
Study Brief:
Protocol Section:
NCT04302766