Clinical Trial: Efficacy of Favipiravir Against Severe Ebola Virus Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy of Favipiravir Against Severe Ebola Virus Disease

Brief 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 Summary: 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.
Sponsor: Beijing Institute of Pharmacology and Toxicology

Current Primary Outcome: Case fatality rate [ Time Frame: 14 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Blood viral load [ Time Frame: 1-3 days ]

Described by Ct (cycle threshold) value


Original Secondary Outcome: Same as current

Information By: Beijing Institute of Pharmacology and Toxicology

Dates:
Date Received: January 19, 2016
Date Started: November 2014
Date Completion:
Last Updated: January 21, 2016
Last Verified: January 2016