Expanded Access Remdesivir (RDV; GS-5734™)

Overview

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

Full Title of Study: “Intermediate-Size Patient Population Expanded Access Treatment Protocol for Coronavirus Disease 2019 (COVID-19) Remdesivir (RDV; GS-5734™)”

Study Type

  • Study Type: Expanded Access

Detailed 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)

Interventions

  • Drug: Remdesivir
    • 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • U.S. Army Medical Research and Development Command
  • Provider of Information About this Clinical Study
    • Sponsor

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