NCT04396106

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

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AT-527 in Subjects With Moderate COVID-19

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Atea Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-05-26
• Primary completion: 2022-01-10
• Completion: 2022-02-28
• First posted: 2020-05-20
• Last updated: 2023-03-09
• Results posted: 2023-03-09

Locations

37 sites across 10 countries: United States, Argentina, Belgium, Brazil, Egypt, Moldova, Romania, South Africa, Spain, Ukraine

Regulatory

• FDA-regulated drug study