Coronavirus Disease 2019NCT04302766
Expanded Access Remdesivir (RDV; GS-5734™)
A study testing Remdesivir in people with Coronavirus Disease 2019, run by U.S. Army Medical Research and Development Command at 22 sites in 8 countries.
Trial summary
Disease caused by 2019 Novel Coronavirus also known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronavirus Disease 2019
- What is being tested?
- Remdesivir
- How many people
- Not given
- Where
- 22 sitesin 8 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
22 sites in 8 countries.
22 sites in 8 countries
United States14 sites
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-0001
William Beaumont Army Medical Center
El Paso, Texas, 79920-5001
Benning Martin Army Community Hospital
Fort Benning, Georgia, 31905
Womack Army Medical Center
Fort Bragg, North Carolina, 28310-7324
Blanchfield Army Community Hospital
Fort Campbell North, Kentucky, 42223-5318
Eisenhower Army Medical Center
Fort Gordon, Georgia, 30905-5741
Carl R. Darnall Army Medical Center
Fort Hood, Texas, 76544-5095
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234-4504
Naval Hospital Jacksonville
Jacksonville, Florida, 32214-5005
Naval Medical Center Camp Lejeune
Marine Corps Base Camp Lejeune, North Carolina, 28547-2538
Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708-2197
Naval Medical Center San Diego
San Diego, California, 92134-5000
Madigan Army Medical Center
Tacoma, Washington, 98431-0001
Tripler Army Medical Center
Tripler AMC, Hawaii, 96859-5000
Afghanistan2 sites
Craig Joint Theater Hospital
Bagrām, 09354
NATO Role 3 Multinational Medical Unit Kandahar Air Field
Kandahar
Djibouti1 site
EMF Camp Lemonnier
Djibouti
Kuwait1 site
US Military Hospital Kuwait 411th Hospital Center
Kuwait City, 09366-9998
About this study
Official title: 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)
Read the 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)
- Conditions
- Coronavirus Disease 2019
- Being tested
- Remdesivir
- Keywords
- COVID-19, GS-5734, Remdesivir, SARS-CoV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemdesivirDrug
Also called GS-5734
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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Disease 2019Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302766
- Sponsor's protocol ID
- S-20-01
- Status last verified
- Feb 2022
- First submitted
- 2 Mar 2020
- Last updated
- 17 Feb 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermediate-Size Patient Population Expanded Access Treatment Protocol for Coronavirus Disease 2019 (COVID-19) Remdesivir (RDV; GS-5734™)
- ClinicalTrials.gov ID
- NCT04302766
- Acronym / sponsor ID
- S-20-01
- Conditions
- Coronavirus Disease 2019
- Keywords
- COVID-19, GS-5734, Remdesivir, SARS-CoV-2
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- First posted
- 10 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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])
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemdesivirAlso: GS-5734Remdesivir (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). | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remdesivir in people with Coronavirus Disease 2019, run by U.S. Army Medical Research and Development Command at 22 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Afghanistan, Djibouti, Germany, Guam and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022.