Study of the Use of Favipiravir in Hospitalized Subjects With COVID-19

NCT04358549 ↗

Phase 2 Completed 50 enrolled Fujifilm Pharmaceuticals U.S.A., Inc.

RandomizedParallel-groupOpen-labelTreatment

Summary

To determine the effect of favipiravir + SOC v. SOC on COVID-19 viral clearance.

Timeline

Start: 2020-04-17
Primary completion: 2020-09-30
Completion: 2020-10-30

Outcome

Met primary endpoint

registry MEDIAN Favipiravir Treatment Arm: 16.0 (12.0 to 29.0) days MEDIAN Standard of Care Arm: 30.0 (12.0 to 31.0) days NCT04358549 ↗

registry analysis (superiority test); Favipiravir Treatment Arm vs Standard of Care Arm; p = 0.0415; Median Difference (Final Values) 14; Log Rank NCT04358549 ↗

Publications

Finberg RW, Ashraf M, Julg B, Ayoade F, Marathe JG, Issa NC, Wang JP, Jaijakul S, Baden LR, Epstein C. US201 Study: A Phase 2, Randomized Proof-of-Concept Trial of Favipiravir for the Treatment of COVID-19. Open Forum Infect Dis. 2021 Dec 7;8(12):ofab563. doi: 10.1093/ofid/ofab563. eCollection 2021 Dec.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Favipiravir	Small molecule	800 mg	Oral
Subject	Favipiravir	Small molecule	1000 mg	Oral