NCT02662855

Efficacy of Favipiravir Against Severe Ebola Virus Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Beijing Institute of Pharmacology and Toxicology · Academic / Other
• Sex: All
• Age: 13 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore the therapeutic efficacy of Favipiravir, a broad-spectrum antiviral drug against severe cases of Ebola Virus Disease (EVD), which is the most difficult aspect for clinical management of EVD due to its high fatality rate.

Detailed description

This is a prospective, open-label, controlled phase 2 trial of Favipiravir among severe cases (cases with hemorrhage, severe dehydration, consciousness disorders, shock, and high blood viral load with Ct value below 20) of confirmed EVD patients in the capital area of Sierra Leone. Patients with 13 years of age or older would be assigned in an 1:1 randomised manner to receive WHO-recommended therapy (mainly symptomatic and supportive therapies, control group. WHO, World Health Organization.) or oral Favipiravir (1600 mg twice on the first day, followed by a twice-daily dose of 600 mg until negative blood viral load detection or death) plus WHO-recommended therapy (treatment group). The primary efficacy end point was case fatality rate.The secondary efficacy endpoint is blood (plasma)viral load. Optimal inclusion number is 240 cases (120 for each group), but considering the actual situation of pandemic area, the front line doctors have the right to reset the inclusion number, and modify the study protocol according to the actual situation in the front.

Conditions

• Ebola Virus Disease

Interventions

Type	Name	Description
OTHER	WHO-recommended therapies	symptomatic and supportive treatments according to the WHO manual
DRUG	Favipiravir	oral administration of Favipiravir tablets

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-04-01
• Completion: 2015-05-01
• First posted: 2016-01-26
• Last updated: 2016-01-26