Safety and Efficacy of AT-527 in Subjects With Moderate Coronavirus Disease (COVID-19) in a Hospital Setting
Stopped early · Phase 2 · Has a placebo group
Conditions studied: COVID-19
In brief
The objectives of this study are to evaluate the safety, tolerability, antiviral activity and efficacy of AT-527 in adult subjects ≥18 years of age with moderate COVID-19 and risk factors for poor outcomes (such as obesity (BMI\>30), hypertension, diabetes or asthma). Eligible subjects will be randomized to blinded AT-527 (nucleotide analog) tablets or matching placebo tablets to be administered orally for 5 days. Part A will evaluate an AT-527 dose of 550 mg BID and Part B will evaluate a second dose of AT-527 (1100 mg BID). Local supportive standard of care (SOC) will be allowed for all subjects. Efficacy, antiviral activity and safety observations will be compared for treatment with active AT-527 tablets vs. placebo tablets.
Key facts
- Study ID
- NCT04396106
- Run by
- Atea Pharmaceuticals, Inc.
- People needed
- 83
- Starts
- 2020-05-26
- Expected to finish
- 2022-02-28
- Last updated by the study team
- 2023-03-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
Full record on ClinicalTrials.gov
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