Clinical trial NCT02662855: Efficacy of Favipiravir Against Severe Ebola Virus Disease
Official title: Efficacy of Favipiravir Against Severe Ebola Virus Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ebola Virus Disease
Lead sponsor: Beijing Institute of Pharmacology and Toxicology
Sponsor class: OTHER
Collaborators: name: Beijing 302 Hospital
name: 307 Hospital of PLA
name: Sierra Leone-China Friendship Hospital
name: Centers for Disease Control and Prevention, China
First posted: 2016-01-26
Enrollment: 77
Sex: ALL
Minimum age (years): 13
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility 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

Primary outcomes:
measure: Case fatality rate
timeFrame: 14 days
Secondary outcomes:
measure: Blood viral load
timeFrame: 1-3 days
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Institute of Pharmacology and Toxicology
name: Wu Zhong, PhD
role: PRINCIPAL_INVESTIGATOR
References: