NCT04600895

The Prevent Severe COVID-19 (PRESECO) Study

Favipiravir for Patients With Mild to Moderate Disease From Novel Coronavirus (COVID-19)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,187 (actual)
• Sponsor: Appili Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

COVID-19 starts as a pure viral infection and evolves into a multifactorial disease with components of hyper immune activation, end organ damage, and fibrosis. Suppression of viral replication is expected to be impactful early in the course of disease. The ability to mitigate the symptoms at an early stage will prevent progression to severe COVID-19 and can save many lives. Early treatment could also reduce viral shedding, diminishing the period of infectivity and decreasing the number of secondary cases.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	Favipiravir	Favipiravir
DRUG	Placebo	Placebo

Timeline

• Start date: 2020-11-30
• Primary completion: 2021-10-20
• Completion: 2021-10-20
• First posted: 2020-10-23
• Last updated: 2024-03-29
• Results posted: 2024-03-29

Locations

38 sites across 3 countries: United States, Brazil, Mexico

Regulatory

• FDA-regulated drug study