drugset
drugset / Trial / NCT04411433

Efficacy and Safety of Hydroxychloroquine and Favipiravir in the Treatment of Mild to Moderate COVID-19

NCT04411433 ↗

Phase 3 Unknown 1008 enrolled Ministry of Health, Turkey Ankara City Hospital Bilkent · collabAnkara Training and Research Hospital · collabAnkara University · collabEge University Hospital (Application and Research Center) · collabHacettepe University · collabIstanbul University · collabIstanbul University - Cerrahpasa · collabKayseri City Hospital · collabKocaeli Derince Education and Research Hospital · collabProf. Dr. Cemil Tascıoglu Education and Research Hospital Organization · collabSB Istanbul Education and Research Hospital · collabSultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey · collabTepecik Training and Research Hospital · collabUmraniye Education and Research Hospital · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label, multicenter, parallel-group, randomized, phase III trial that evaluates the efficacy and safety of hydroxychloroquine and favipiravir in the treatment of patients with possible or confirmed COVID-19 observed within the last 5 days. 1000 patients will be randomized in 2:1:2:2:2:1 ratio and divided into six groups.

Timeline

Start
2020-05-08
Primary completion
2020-12-31
Completion
2021-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Azithromycin Small molecule 250 mg Oral
Subject Favipiravir Small molecule 1200 mg Oral
Subject Favipiravir Small molecule 1600 mg Oral
Comparator Hydroxychloroquine Small molecule 400 mg Oral

Indications

COVID-19