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.
Drug: AT-527
One 550 mg tablet of AT-527 administered every ~12 hours (twice a day) for a total of 5 days
Other: Placebo
One placebo tablet administered every ~12 hours (twice a day) for a total of 5 days
Drug: AT-527
Two 550 mg tablets of AT-527 administered every ~12 hours (twice a day) for a total of 5 days
Other: Placebo
Two placebo tablets administered every ~12 hours (twice a day) for a total of 5 days
Key Inclusion Criteria:
- Hospitalized or in a hospital-affiliated confinement facility
- 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.
Key Exclusion Criteria:
- Severe or critical COVID-19 illness: RR ≥30, HR ≥125, SpO2 <93% on room air or
requires >2L/min oxygen by nasal cannula or mask to maintain SpO2 ≥93%, systolic blood
pressure < 90 mm Hg, diastolic blood pressure < 60 mm Hg or PaO2/FiO2 <300
- 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).
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, 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 Lopez, 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, Republic of
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