Expanded Access Remdesivir (RDV; GS-5734™)

United States Army Medical Research and Development Command (USAMRDC)

Status

Conditions: Coronavirus Disease 2019

Treatments: Drug: Remdesivir

Study type: Expanded Access

Funder types: Other U.S. Federal agency

Identifiers

NCT04302766

S-20-01

Details and patient eligibility

About

Disease caused by 2019 Novel Coronavirus also known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

Full 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)

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design