Efficacy of Favipiravir Against Severe Ebola Virus Disease

Ebola Virus Disease Clinical Trial

Official title:

Efficacy of Favipiravir Against Severe Ebola Virus Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02662855
• Other study ID #: IPT-125
• Status: Completed
• Phase: Phase 2
• First received: January 19, 2016
• Last updated: January 21, 2016
• Start date: November 2014
• Est. completion date: May 2015

Study information

• Verified date: January 2016
• Source: Beijing Institute of Pharmacology and Toxicology
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ebola Virus Disease
• Hemorrhagic Fever, Ebola
• Virus Diseases

Intervention

Other:
• WHO-recommended therapies
symptomatic and supportive treatments according to the WHO manual

Drug:
• Favipiravir
oral administration of Favipiravir tablets

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Beijing Institute of Pharmacology and Toxicology	307 Hospital of PLA, Beijing 302 Hospital, Centers for Disease Control and Prevention, China, Sierra Leone-China Friendship Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Case fatality rate		14 days	No
Secondary	Blood viral load	Described by Ct (cycle threshold) value	1-3 days	No