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Expanded Access Remdesivir (RDV; GS-5734™)

Primary Purpose

Coronavirus Disease 2019

Status
No longer available
Phase
Locations
International
Study Type
Expanded Access
Intervention
Remdesivir
Sponsored by
U.S. Army Medical Research and Development Command
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Coronavirus Disease 2019 focused on measuring COVID-19, GS-5734, Remdesivir, SARS-CoV-2

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All Sexes

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

Sites / Locations

  • Naval Medical Center San Diego
  • Naval Hospital Jacksonville
  • Benning Martin Army Community Hospital
  • Eisenhower Army Medical Center
  • Tripler Army Medical Center
  • Blanchfield Army Community Hospital
  • Walter Reed National Military Medical Center
  • Naval Medical Center Camp Lejeune
  • Womack Army Medical Center
  • William Beaumont Army Medical Center
  • Carl R. Darnall Army Medical Center
  • Brooke Army Medical Center
  • Naval Medical Center Portsmouth
  • Madigan Army Medical Center
  • Craig Joint Theater Hospital
  • NATO Role 3 Multinational Medical Unit Kandahar Air Field
  • EMF Camp Lemonnier
  • Landstuhl Regional Medical Center
  • US Naval Hospital Guam
  • Baghdad Diplomatic Support Center
  • US Naval Hospital Okinawa
  • US Military Hospital Kuwait 411th Hospital Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 2, 2020
Last Updated
February 15, 2022
Sponsor
U.S. Army Medical Research and Development Command
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1. Study Identification

Unique Protocol Identification Number
NCT04302766
Brief Title
Expanded Access Remdesivir (RDV; GS-5734™)
Official Title
Intermediate-Size Patient Population Expanded Access Treatment Protocol for Coronavirus Disease 2019 (COVID-19) Remdesivir (RDV; GS-5734™)
Study Type
Expanded Access

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
U.S. Army Medical Research and Development Command

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Disease 2019
Keywords
COVID-19, GS-5734, Remdesivir, SARS-CoV-2

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Remdesivir
Other Intervention Name(s)
GS-5734
Intervention Description
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).

10. Eligibility

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

12. IPD Sharing Statement

Learn more about this trial

Expanded Access Remdesivir (RDV; GS-5734™)

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