Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NO_LONGER_AVAILABLE
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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Conditions
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Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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U.S. Army Medical Research and Development Command
FED
Responsible Party
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Locations
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Naval Medical Center San Diego
San Diego, California, United States
Naval Hospital Jacksonville
Jacksonville, Florida, United States
Benning Martin Army Community Hospital
Fort Benning, Georgia, United States
Eisenhower Army Medical Center
Fort Gordon, Georgia, United States
Tripler Army Medical Center
Tripler AMC, Hawaii, United States
Blanchfield Army Community Hospital
Fort Campbell North, Kentucky, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Womack Army Medical Center
Fort Bragg, North Carolina, United States
Naval Medical Center Camp Lejeune
Marine Corps Base Camp Lejeune, North Carolina, United States
William Beaumont Army Medical Center
El Paso, Texas, United States
Carl R. Darnall Army Medical Center
Fort Hood, Texas, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
Naval Medical Center Portsmouth
Portsmouth, Virginia, United States
Madigan Army Medical Center
Tacoma, Washington, United States
Craig Joint Theater Hospital
Bagrām, , Afghanistan
NATO Role 3 Multinational Medical Unit Kandahar Air Field
Kandahar, , Afghanistan
EMF Camp Lemonnier
Djibouti, , Djibouti
Landstuhl Regional Medical Center
Landstuhl, APO AE, Germany
US Naval Hospital Guam
Hagåtña, , Guam
Baghdad Diplomatic Support Center
Baghdad, , Iraq
US Naval Hospital Okinawa
Okinawa, , Japan
US Military Hospital Kuwait 411th Hospital Center
Kuwait City, , Kuwait
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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S-20-01
Identifier Type: -
Identifier Source: org_study_id
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