Safety and Efficacy of AT-527 in Subjects With Moderate Coronavirus Disease (COVID-19) in a Hospital Setting
NCT ID: NCT04396106
Last Updated: 2023-03-09
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
83 participants
INTERVENTIONAL
2020-05-26
2022-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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AT-527 - 550 mg BID
Part A
AT-527
One 550 mg tablet of AT-527 administered every \~12 hours (twice a day) for a total of 5 days
Placebo for 550 mg BID
Part A
Placebo
One placebo tablet administered every \~12 hours (twice a day) for a total of 5 days
AT-527 - 1100 mg BID
Part B
AT-527
Two 550 mg tablets of AT-527 administered every \~12 hours (twice a day) for a total of 5 days
Placebo for 1100 mg BID
Part B
Placebo
Two placebo tablets administered every \~12 hours (twice a day) for a total of 5 days
Interventions
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AT-527
One 550 mg tablet of AT-527 administered every \~12 hours (twice a day) for a total of 5 days
Placebo
One placebo tablet administered every \~12 hours (twice a day) for a total of 5 days
AT-527
Two 550 mg tablets of AT-527 administered every \~12 hours (twice a day) for a total of 5 days
Placebo
Two placebo tablets administered every \~12 hours (twice a day) for a total of 5 days
Eligibility Criteria
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Inclusion Criteria
* SARS-CoV-2 positive
* Initial COVID-19 symptom onset within 5 days prior to Screening
* SpO2 ≥ 93% on room air or requires ≤ 2L/min oxygen by nasal cannula or mask to maintain SpO2 ≥ 93%
* Must also have a history of at least one of the following known risk factors for poor outcomes: obesity (BMI\>30), hypertension, diabetes or asthma.
Exclusion Criteria
* Requires mechanical ventilation
* Lobar or segmental consolidation on chest imaging.
* Treatment with other drugs thought to possibly have activity against SARS-CoV-2
* ALT or AST \> 5 x upper limit of normal (ULN)
* Female subject is pregnant or breastfeeding
* Has received or is expected to receive any dose of a SARS-CoV-2 vaccine before the Day 14 visit (Part B).
18 Years
ALL
No
Sponsors
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Atea Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Atea Study Site
Scottsdale, Arizona, United States
Atea Study Site
Davis, California, United States
Atea Study Site
Los Angeles, California, United States
Atea Study Site
Washington D.C., District of Columbia, United States
Atea Study Site
Orlando, Florida, United States
Atea Study Site
Atlanta, Georgia, United States
Atea Study Site
Chicago, Illinois, United States
Atea Study Site
Chicago, Illinois, United States
Atea Study Site
Boston, Massachusetts, United States
Atea Study Site
Butte, Montana, United States
Atea Study Site
Charlotte, North Carolina, United States
Atea Study Site
Cincinnati, Ohio, United States
Atea Study Site
Columbus, Ohio, United States
Atea Study Site
Charleston, South Carolina, United States
Atea Study Site
Columbia, South Carolina, United States
Atea Study Site
Rosario, , Argentina
Atea Study Site
Vicente López, , Argentina
Atea Study Site
Brussels, , Belgium
Atea Study Site
Mechelen, , Belgium
Atea Study Site
Belo Horizonte, , Brazil
Atea Study Site
Brasília, , Brazil
Atea Study Site
Campo Largo, , Brazil
Atea Study Site
Porto Alegre, , Brazil
Atea Study Site
São Paulo, , Brazil
Atea Study Site
Cairo, , Egypt
Atea Study Site
Chisinau, , Moldova
Atea Study Site
Bucharest, , Romania
Atea Study Site
Bloemfontein, , South Africa
Atea Study Site
Cape Town, , South Africa
Atea Study Site
Centurion, , South Africa
Atea Study Site
George, , South Africa
Atea Study Site
Worcester, , South Africa
Atea Study Site
Barcelona, , Spain
Atea Study Site
Madrid, , Spain
Atea Study Site
Pozuelo de Alarcón, , Spain
Atea Study Site
Brovary, , Ukraine
Atea Study Site
Kyiv, , Ukraine
Countries
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References
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Horga A, Kuritzkes DR, Kowalczyk JJ, Pietropaolo K, Belanger B, Lin K, Perkins K, Hammond J. Phase II study of bemnifosbuvir in high-risk participants in a hospital setting with moderate COVID-19. Future Virol. 2023 Jun;18(8):489-500. doi: 10.2217/fvl-2023-0064. Epub 2023 Jun 23.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AT-03A-001
Identifier Type: -
Identifier Source: org_study_id
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