Ebola Virus Disease
Conditions
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.
Interventions
OTHERWHO-recommended therapies
symptomatic and supportive treatments according to the WHO manual
DRUGFavipiravir
oral administration of Favipiravir tablets
Sponsors
Beijing 302 Hospital
307 Hospital of PLA
Sierra Leone-China Friendship Hospital
Centers for Disease Control and Prevention, China
Beijing Institute of Pharmacology and Toxicology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Case fatality rate | 14 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood viral load | 1-3 days | Described by Ct (cycle threshold) value |
Outcome results
None listed