drugset / Trial / NCT04709835

Study to Evaluate the Effects of AT-527 in Non-Hospitalized Adult Patients With Mild or Moderate COVID-19

Phase 2 Completed 104 enrolled Hoffmann-La Roche Atea Pharmaceuticals, Inc. · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

This randomized study evaluates the antiviral activity, safety, efficacy and pharmacokinetics of AT-527 versus a placebo in participants with mild or moderate coronavirus disease (COVID-19) who are not hospitalized.

Timeline

Start: 2021-02-03
Primary completion: 2021-09-17
Completion: 2021-10-13

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo Matched to AT-527 550 mg vs AT-527 550 mg (1x550 mg); p = 0.4260; Difference in Adjusted Means -0.25 (80% CI -0.66 to 0.16); ANCOVA NCT04709835 ↗

registry analysis (superiority test); Pooled Placebo vs AT-527 1100 mg (4x275 mg); p = 0.8083; Difference in Adjusted Means -0.08 (80% CI -0.48 to 0.33); ANCOVA NCT04709835 ↗

paper The primary endpoint was not met: PMID 37338393 ↗

release “Topline Phase 2 MOONSONG trial results did not meet the primary endpoint in the overall population of patients with mild or moderate COVID-19” ateapharma.com ↗

release “the global Phase 2 MOONSONG trial evaluating AT-527 in the outpatient setting did not meet the primary endpoint” ateapharma.com ↗

Publications

Boffito M, Dolan E, Singh K, Holmes W, Wildum S, Horga A, Pietropaolo K, Zhou XJ, Clinch B, Collinson N, Ukachukwu V. A Phase 2 Randomized Trial Evaluating the Antiviral Activity and Safety of the Direct-Acting Antiviral Bemnifosbuvir in Ambulatory Patients with Mild or Moderate COVID-19 (MOONSONG Study). Microbiol Spectr. 2023 Aug 17;11(4):e0007723. doi: 10.1128/spectrum.00077-23. Epub 2023 Jun 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AT-527	Other / unclassified	550 mg	Oral
Subject	AT-527	Other / unclassified	1100 mg	Oral