Safety and Efficacy of AT-527 in Subjects With Moderate Coronavirus Disease (COVID-19) in a Hospital Setting
Status:
Recruiting
Trial end date:
2022-08-01
Target enrollment:
Participant gender:
Summary
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 (Dose B). 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.