Expanded Access Remdesivir (RDV; GS-5734™)

February 15, 2022 updated by: U.S. Army Medical Research and Development Command

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

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

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

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 Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population
  • Treatment IND/Protocol

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Afghanistan
      • Bagrām, Afghanistan, 09354
        • Craig Joint Theater Hospital
      • Kandahar, Afghanistan
        • NATO Role 3 Multinational Medical Unit Kandahar Air Field
  • Djibouti
      • Djibouti, Djibouti
        • EMF Camp Lemonnier
  • Germany
    • APO Ae
      • Landstuhl, APO Ae, Germany, 09180
        • Landstuhl Regional Medical Center
  • Guam
      • Agaña, Guam, 96910
        • US Naval Hospital Guam
  • Iraq
      • Baghdad, Iraq, 09305
        • Baghdad Diplomatic Support Center
  • Japan
      • Okinawa, Japan, 904-0103
        • US Naval Hospital Okinawa
  • Kuwait
      • Kuwait, Kuwait, 09366-9998
        • US Military Hospital Kuwait 411th Hospital Center
  • United States
    • California
      • San Diego, California, United States, 92134-5000
        • Naval Medical Center San Diego
    • Florida
      • Jacksonville, Florida, United States, 32214-5005
        • Naval Hospital Jacksonville
    • Georgia
      • Fort Benning, Georgia, United States, 31905
        • Benning Martin Army Community Hospital
      • Fort Gordon, Georgia, United States, 30905-5741
        • Eisenhower Army Medical Center
    • Hawaii
      • Tripler AMC, Hawaii, United States, 96859-5000
        • Tripler Army Medical Center
    • Kentucky
      • Fort Campbell North, Kentucky, United States, 42223-5318
        • Blanchfield Army Community Hospital
    • Maryland
      • Bethesda, Maryland, United States, 20889-0001
        • Walter Reed National Military Medical Center
    • North Carolina
      • Camp Lejeune, North Carolina, United States, 28547-2538
        • Naval Medical Center Camp Lejeune
      • Fort Bragg, North Carolina, United States, 28310-7324
        • Womack Army Medical Center
    • Texas
      • El Paso, Texas, United States, 79920-5001
        • William Beaumont Army Medical Center
      • Fort Hood, Texas, United States, 76544-5095
        • Carl R. Darnall Army Medical Center
      • Fort Sam Houston, Texas, United States, 78234-4504
        • Brooke Army Medical Center
    • Virginia
      • Portsmouth, Virginia, United States, 23708-2197
        • Naval Medical Center Portsmouth
    • Washington
      • Tacoma, Washington, United States, 98431-0001
        • Madigan Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

U.S. Army Medical Research and Development Command

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

March 2, 2020

First Submitted That Met QC Criteria

March 6, 2020

First Posted (Actual)

March 10, 2020

Study Record Updates

Last Update Posted (Actual)

February 17, 2022

Last Update Submitted That Met QC Criteria

February 15, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-20-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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