drugset / Trial / NCT04542694

Study of Favipiravir Compared to Standard of Care in Hospitalized Patients With COVID-19

NCT04542694 ↗

Phase 3 Completed 200 enrolled Promomed, LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

This is open-labe randomized multicenter comparative Phase III study conducted in 5 medical facilities. The objective of the study is to assess the efficacy and safety of Favipiravir compared with the Standard of care (SOC) in hospitalized patients with moderate COVID-19 pneumonia.

Timeline

Start
2020-05-21
Primary completion
2020-08-10
Completion
2020-08-20

Outcome

Met primary endpoint

registry analysis (superiority test); Favipiravir (Areplivir) vs Standard of Care; p = 0.0372; The difference in proportions 0.1313 (95% CI -0.0004 to 0.2367); Chi-squared NCT04542694 ↗

registry analysis (superiority test); Favipiravir (Areplivir) vs Standard of Care; p <0.0001; The difference in days 4; Log Rank NCT04542694 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Favipiravir Small molecule 600 mg Oral

Indications