Efficacy of Favipiravir Against Severe Ebola Virus Disease

January 21, 2016 updated by: Beijing Institute of Pharmacology and Toxicology
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 75 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Control
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.
Other: WHO-recommended therapies
symptomatic and supportive treatments according to the WHO manual
EXPERIMENTAL: Treatment
WHO-recommended therapies plus oral administration of Favipiravir
Other: WHO-recommended therapies
symptomatic and supportive treatments according to the WHO manual
Drug: Favipiravir
oral administration of Favipiravir tablets
Other Names:
  • T-705

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Case fatality rate
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood viral load
Time Frame: 1-3 days
Described by Ct (cycle threshold) value
1-3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Investigators

  • Principal Investigator: Wu Zhong, PhD, Beijing Institute of Pharmacology and Toxicology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (ACTUAL)

April 1, 2015

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

January 19, 2016

First Submitted That Met QC Criteria

January 21, 2016

First Posted (ESTIMATE)

January 26, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

January 26, 2016

Last Update Submitted That Met QC Criteria

January 21, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPT-125

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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