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Efficacy of Favipiravir Against Severe Ebola Virus Disease

Primary Purpose

Ebola Virus Disease

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
WHO-recommended therapies
Favipiravir
Sponsored by
Beijing Institute of Pharmacology and Toxicology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ebola Virus Disease

Eligibility Criteria

13 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Control

    Treatment

    Arm 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.

    WHO-recommended therapies plus oral administration of Favipiravir

    Outcomes

    Primary Outcome Measures

    Case fatality rate

    Secondary Outcome Measures

    Blood viral load
    Described by Ct (cycle threshold) value

    Full Information

    First Posted
    January 19, 2016
    Last Updated
    January 21, 2016
    Sponsor
    Beijing Institute of Pharmacology and Toxicology
    Collaborators
    Beijing 302 Hospital, 307 Hospital of PLA, Sierra Leone-China Friendship Hospital, Centers for Disease Control and Prevention, China
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02662855
    Brief Title
    Efficacy of Favipiravir Against Severe Ebola Virus Disease
    Official Title
    Efficacy of Favipiravir Against Severe Ebola Virus Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2014 (undefined)
    Primary Completion Date
    April 2015 (Actual)
    Study Completion Date
    May 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Beijing Institute of Pharmacology and Toxicology
    Collaborators
    Beijing 302 Hospital, 307 Hospital of PLA, Sierra Leone-China Friendship Hospital, Centers for Disease Control and Prevention, China

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ebola Virus Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    77 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    Treatment
    Arm Type
    Experimental
    Arm Description
    WHO-recommended therapies plus oral administration of Favipiravir
    Intervention Type
    Other
    Intervention Name(s)
    WHO-recommended therapies
    Intervention Description
    symptomatic and supportive treatments according to the WHO manual
    Intervention Type
    Drug
    Intervention Name(s)
    Favipiravir
    Other Intervention Name(s)
    T-705
    Intervention Description
    oral administration of Favipiravir tablets
    Primary Outcome Measure Information:
    Title
    Case fatality rate
    Time Frame
    14 days
    Secondary Outcome Measure Information:
    Title
    Blood viral load
    Description
    Described by Ct (cycle threshold) value
    Time Frame
    1-3 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wu Zhong, PhD
    Organizational Affiliation
    Beijing Institute of Pharmacology and Toxicology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy of Favipiravir Against Severe Ebola Virus Disease

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