Efficacy of Favipiravir Against Severe Ebola Virus Disease

Beijing Institute of Pharmacology and Toxicology

Status and phase: Completed; Phase 2

Conditions: Ebola Virus Disease

Treatments: Drug: Favipiravir; Other: WHO-recommended therapies

Study type: Interventional

Funder types: Other

Identifiers

NCT02662855

IPT-125

Details and patient eligibility

About

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.

Full 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.

Enrollment: 77 patients

Sex: All

Ages: 13 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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77 participants in 2 patient groups

Control

Active Comparator group

Description:

WHO-recommended therapies, mainly symptomatic and supportive treatments. Briefly: body fluid management (intravenous or oral, depending on patient status), balanced nutrition (including glucose, electrolytes, vitamin, et al.), preventing intravascular volume depletion, correcting profound electrolyte abnormalities, avoiding the complications of shock, defervesce, anti-diarrheal, acesodyne, anti-anxiety. For patients with positive Plasmodium detection or bacterial infection, apply artemether-lumefantrine or antibiotics respectively. Details refer to 'Manual for the care and management of patients in Ebola Care Units/Community Care Centres, Interim emergency guidance' and 'Clinical Management of Patients with Viral Haemorrhagic Fever: A Pocket Guide for the Front-line Health Worker' by WHO.

Treatment:

Other: WHO-recommended therapies

Treatment

Experimental group

Description:

WHO-recommended therapies plus oral administration of Favipiravir

Treatment:

Other: WHO-recommended therapies

Drug: Favipiravir