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.
One 550 mg tablet of AT-527 administered every \~12 hours (twice a day) for a total of 5 days
One placebo tablet administered every \~12 hours (twice a day) for a total of 5 days
Two 550 mg tablets of AT-527 administered every \~12 hours (twice a day) for a total of 5 days
Two placebo tablets administered every \~12 hours (twice a day) for a total of 5 days
Rosario, Argentina
Vicente López, Argentina