Safety and Efficacy of AT-527 in Subjects With Moderate Coronavirus Disease (COVID-19) in a Hospital Setting

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 (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.

Timeline

Start

2020-05-26

Primary completion

2022-01-10

Completion

2022-02-28

Publications

• 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.

Drugs

Indications