Clinical Trial Evaluating the Efficacy and Safety of Favipiravir in Moderate to Severe COVID-19 Patients

Summary

This is a prospective, interventional, multi-centre, phase III, randomized, double blind, placebo-controlled, parallel design trial to evaluate the efficacy, safety and tolerability of favipiravir as adjunct ('add on') to supportive care, in comparison to placebo with supportive care, in the acute treatment of patients who have tested positive for SARS-CoV-2 and presenting with moderate to severe COVID-19. This study will be conducted in two parts; Stage I - Main study and Stage II - Extended Follow up.

Timeline

Start

2020-08-22

Primary completion

2021-01-22

Completion

2021-01-27

Outcome

Missed primary endpoint

Stopped: “Study met pre-defined criteria for futility at interim analysis”

registry analysis (superiority test); Favipiravir + Supportive Care vs Placebo + Supportive Care; p = 0.67; Log Rank NCT04529499 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Favipiravir	Small molecule	800 mg	—

Indications