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Expanded Access Remdesivir (RDV; GS-5734™)

Sponsor
U.S. Army Medical Research and Development Command (U.S. Fed)
Overall Status
No longer available
CT.gov ID
NCT04302766
Collaborator
(none)
22
Locations

Study Details

Study Description

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 Phase

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

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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    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

    Locations

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

    Sponsors and Collaborators

    • U.S. Army Medical Research and Development Command

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    U.S. Army Medical Research and Development Command
    ClinicalTrials.gov Identifier:
    NCT04302766
    Other Study ID Numbers:
    • S-20-01
    First Posted:
    Mar 10, 2020
    Last Update Posted:
    Feb 17, 2022
    Last Verified:
    Feb 1, 2022
    Keywords provided by U.S. Army Medical Research and Development Command
    COVID-19
    GS-5734
    Remdesivir
    SARS-CoV-2
    Additional relevant MeSH terms:
    Coronavirus Infections
    COVID-19
    Remdesivir

    Study Results

    No Results Posted as of Feb 17, 2022