Efficacy of Favipiravir Against Severe Ebola Virus Disease

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Institute of Pharmacology and Toxicology
• Collaborators: 307 Hospital of PLA; Beijing 302 Hospital; Centers for Disease Control and Prevention, China; Sierra Leone-China Friendship Hospital
• Treatments: Favipiravir

Criteria

Inclusion Criteria:

• Male or famale，13 -75 years of age

• Clinical diagnosis of EVD

• Positive blood viral RNA detection

• With any one of the symptoms below:

Hemorrhage (including hematemesis, hemoptysis, hematochezia, hematuria, mucocutaneous hemorrhage), severe dehydration (including oliguria, anuria, feebleness, hypotension, tachycardia), consciousness disorders (including coma, delirium, confusion, convulsion), shock, and high blood viral load (Ct value below 20)

• Not received any therapies for EVD

• Provided written informed consent, by guardian or the patient himself

• Be able to administrate and tolerate oral administration of tablets

Exclusion Criteria:

• Severe vomiting

• Pregnancy and breast-feeding

• Received antiviral treatment against EVD