Clinical trial NCT04302766: 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
Overall status: NO_LONGER_AVAILABLE
Conditions: Coronavirus Disease 2019
Keywords: COVID-19
GS-5734
Remdesivir
SARS-CoV-2
Lead sponsor: U.S. Army Medical Research and Development Command
Sponsor class: FED
First posted: 2020-03-10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

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)

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
city: Jacksonville
country: United States
facility: Naval Hospital Jacksonville
state: Florida
city: Fort Benning
country: United States
facility: Benning Martin Army Community Hospital
state: Georgia
city: Fort Gordon
country: United States
facility: Eisenhower Army Medical Center
state: Georgia
city: Tripler AMC
country: United States
facility: Tripler Army Medical Center
state: Hawaii
city: Fort Campbell North
country: United States
facility: Blanchfield Army Community Hospital
state: Kentucky
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Camp Lejeune
country: United States
facility: Naval Medical Center Camp Lejeune
state: North Carolina
city: Fort Bragg
country: United States
facility: Womack Army Medical Center
state: North Carolina
city: El Paso
country: United States
facility: William Beaumont Army Medical Center
state: Texas
city: Fort Hood
country: United States
facility: Carl R. Darnall Army Medical Center
state: Texas
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
city: Portsmouth
country: United States
facility: Naval Medical Center Portsmouth
state: Virginia
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
city: Bagrām
country: Afghanistan
facility: Craig Joint Theater Hospital
city: Kandahar
country: Afghanistan
facility: NATO Role 3 Multinational Medical Unit Kandahar Air Field
city: Djibouti
country: Djibouti
facility: EMF Camp Lemonnier
city: Landstuhl
country: Germany
facility: Landstuhl Regional Medical Center
state: APO Ae
city: Agaña
country: Guam
facility: US Naval Hospital Guam
city: Baghdad
country: Iraq
facility: Baghdad Diplomatic Support Center
city: Okinawa
country: Japan
facility: US Naval Hospital Okinawa
city: Kuwait
country: Kuwait
facility: US Military Hospital Kuwait 411th Hospital Center
Study officials:
References: