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Intermediate-Size Patient Population Expanded Access Treatment Protocol for Coronavirus Disease 2019 (COVID-19) Remdesivir (RDV; GS-5734™)

Trial Profile

Intermediate-Size Patient Population Expanded Access Treatment Protocol for Coronavirus Disease 2019 (COVID-19) Remdesivir (RDV; GS-5734™)

Status: Recruiting
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 13 Apr 2020

At a glance

  • Drugs Remdesivir (Primary)
  • Indications COVID 2019 infections
  • Focus Expanded access; Therapeutic Use
  • Most Recent Events

    • 19 Mar 2020 The U.S. Food and Drug Administration media release,to date, the agency has already granted about 250 patients access to this product.
    • 12 Mar 2020 New trial record

Trial Overview

Purpose

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)

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Sex male & female
  • Age Group ≥ 18 years; Adult

Patient 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

Patient 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 Details

Identifiers

Identifier Owner
NCT04302766 ClinicalTrials.gov: US National Institutes of Health
S20-01 -

Trial Dates

Other Details

  • Design prospective
  • Phase of Trial Clinical Phase Unknown
  • Location USA
  • Focus Expanded access; Therapeutic Use

Interventions

Drugs Route Formulation
RemdesivirPrimary Drug Intravenous Injection

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).) Other Name: GS-5734

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Sandi K Parriott
301-619-6824
sandi.k.parriott.mil@mail.mil
show details
-

Centres

Centre Name Location Trial Centre Country
-
-
-
U.S. Army Medical Research and Development Command
-
-

Trial History

Event Date Event Type Comment
13 Apr 2020 Other trial event Last checked against Clinicaltrials.gov record. Updated 13 Apr 2020
19 Mar 2020 Other trial event The U.S. Food and Drug Administration media release,to date, the agency has already granted about 250 patients access to this product. Updated 20 Mar 2020
12 Mar 2020 New trial record New trial record Updated 12 Mar 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. Food and Drug Administration. Coronavirus (COVID-19) Update: FDA Continues to Facilitate Development of Treatments. Media-Rel 2020;.

    Media Release
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