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Expanded Access Remdesivir (RDV; GS-5734™)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04302766
Expanded Access Status : No longer available
First Posted : March 10, 2020
Last Update Posted : February 17, 2022
Sponsor:
Information provided by (Responsible Party):
U.S. Army Medical Research and Development Command

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

Condition or disease Intervention/treatment
Coronavirus Disease 2019 Drug: Remdesivir

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)
Study Design
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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population, Treatment IND/Protocol
Official Title: Intermediate-Size Patient Population Expanded Access Treatment Protocol for Coronavirus Disease 2019 (COVID-19) Remdesivir (RDV; GS-5734™)

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • 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
Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04302766


Locations
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Sponsors and Collaborators
U.S. Army Medical Research and Development Command
  Study Documents (Full-Text)

Documents provided by U.S. Army Medical Research and Development Command:
Informed Consent Form  [PDF] June 23, 2020

More Information
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Responsible Party: U.S. Army Medical Research and Development Command
ClinicalTrials.gov Identifier: NCT04302766    
Other Study ID Numbers: S-20-01
First Posted: March 10, 2020    Key Record Dates
Last Update Posted: February 17, 2022
Last Verified: February 2022
Keywords provided by U.S. Army Medical Research and Development Command:
COVID-19
GS-5734
Remdesivir
SARS-CoV-2
Additional relevant MeSH terms:
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Coronavirus Infections
COVID-19
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Infections
Pneumonia, Viral
Pneumonia
 Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Remdesivir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents