The Prevent Severe COVID-19 (PRESECO) Study

Phase 3 Completed 1187 enrolled Appili Therapeutics Inc.

RandomizedParallel-groupTriple-blindTreatment

Summary

Double-blinded, placebo control, randomized, phase-3 clinical trial to evaluate clinical efficacy of Favipiravir in patients with mild to moderate symptoms related to COVID-19 infection

Timeline

Start: 2020-11-30
Primary completion: 2021-10-20
Completion: 2021-10-20

Outcome

Missed primary endpoint

paper There was no difference in TT-SCR (median of 7 days for both groups; P = .80) PMID 36065065 ↗

paper Favipiravir was well tolerated but lacked efficacy in TT-SCR PMID 36065065 ↗

release “PRESECO (PREventing SEvere COVID-19) clinical trial evaluating oral antiviral Avigan®/Reeqonus™(favipiravir) for the treatment of mild-to-moderate COVID-19 did not achieve statistical significance on the primary endpoint” appilitherapeutics.com ↗

Publications

Golan Y, Campos JAS, Woolson R, Cilla D, Hanabergh R, Gonzales-Rojas Y, Lopez R, Finberg R, Balboni A. Favipiravir in Patients With Early Mild-to-moderate Coronavirus Disease 2019 (COVID-19): A Randomized Controlled Trial. Clin Infect Dis. 2023 Feb 8;76(3):e10-e17. doi: 10.1093/cid/ciac712.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Favipiravir	Small molecule	200 mg	—