Efficacy of Favipiravir Against Ebola (JIKI) (JIKI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02329054|
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : November 15, 2016
There is no specific treatment for Ebola Virus Disease (EVD). Current EVD care are supportive, and includes intravenous or oral rehydration, nutrition, pain killers, treatment of coinfections with antibacterial and antimalarial drugs, and blood transfusion when appropriate. Despite these interventions, mortality remains high since the ongoing Ebola outbreak in West Africa was declared in April.
Potential anti-Ebola specific interventions include convalescent plasma, monoclonal and polyclonal antibodies, small inhibitory RNA (siRNA), synthetic adenosine analogues or RNA polymerase inhibitors. All these interventions are considered investigational due to lack of data in humans with EVD.
In this study, the investigators chose to study the efficacy of favipiravir because this drug:
- showed anti-Ebola efficacy in immunodeficient murine models;
- has been studied in thousands of adult humans participating in anti-influenza trials, with good tolerance; it has been approved for treating novel or resistant influenza infections in Japan;
- is immediately available;
- can be used orally, and can be easily given in both adults and children because pills can be crushed and mixed in food or liquids;
- has recently been used in Europe for treating several patients with EVD; the French drug safety agency (ANSM) has reviewed published data as well as data provided by the firm (Toyama Chemical Co., Ltd), and approved its compassionate use in EVD.
Here the investigators propose to assess the efficacy of high-dosed favipiravir in reducing mortality in humans with EVD.
In the present trial "JIKI" (means "Hope" in "Kissi" language), investigators, sponsor, scientific advisory board and safety monitoring board will be coordinated in a very reactive way, so that any new fact can be discussed rapidly and the research plan can be adapted accordingly (change in drug dosage; use of drug combination; combination with another strategy such as passive immunization with convalescent plasma, etc.).
|Condition or disease||Intervention/treatment||Phase|
|Ebola Virus Disease||Drug: Favipiravir||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||126 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Favipiravir in Reducing Mortality in Individuals With Ebola Virus Disease in Guinea|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||September 2015|
Favipiravir (oral administration, 200 mg light yellow, round-shaped, coated divisible tablets that can be crushed and mixed with liquid)
Group A1: Day-0 (inclusion), h0: 2400 mg; h8: 2400 mg; h16: 1200 mg. Day-1 to Day-9: 1200 mg bid.
Group A2: Day-0 (inclusion), h0: 2400 mg; h8: 2400 mg; h16: 1200 mg. Day-1 to Day-9: 1200 mg bid.
Group C: daily dosages will be adapted to their body weight.
Other Name: AVIGAN
- Mortality [ Time Frame: Day-14 ]Day-0 is the day of the first dose of favipiravir
- Evolution of EBOV plasma RNA and infectious loads [ Time Frame: routine care venepuncture (Day-0; end of symptoms (EOS)+72h and EOS+96h if EOS >Day-9; or Day-12 and Day-13 if EOS <Day-9); (ii) additional trial venepuncture at: Day-2, Day-4 and Day-30 in group A1; Day-2 and Day-30 in group A2 ]
- Occurrence of grade 3 or 4 clinical or biological adverse events (Common Terminology Criteria for Adverse Events, CTAE, v3.0) [ Time Frame: participants will be followed for the duration of hospital stay up to Day-14 ]
- Evolution of viral micro-diversity of EBOV (including potential resistance mutations) [ Time Frame: routine care venepuncture (Day-0; end of symptoms (EOS)+72h and EOS+96h if EOS >Day-9; or Day-12 and Day-13 if EOS <Day-9); (ii) additional trial venepuncture at: Day-2, Day-4 and Day-30 in group A1; Day-2 and Day-30 in group A2 ]
- Plasma trough concentrations of favipiravir [ Time Frame: routine care venepuncture (Day-0; end of symptoms (EOS)+72h and EOS+96h if EOS >Day-9; or Day-12 and Day-13 if EOS <Day-9); (ii) additional trial venepuncture at: Day-2, Day-4 and Day-30 in group A1; Day-2 and Day-30 in group A2 ]
- Criteria for cure [ Time Frame: Day-30 ]
Composite criteria for cure are the following:
- 4 days without fever or significant symptoms AND;
- able to feed and walk independently AND;
- two consecutive negative qualitative PCR.
- Mortality [ Time Frame: Day-14 according to the second group definition (AC1, AC2, YC) ]Day-0 is the day of the first dose of favipiravir
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329054
|The caregivers treatment center|
|MSF Ebola treatment centre|
|French Red Cross Ebola care center|
|ALIMA Ebola care center|
|Principal Investigator:||Denis Malvy, Professor||CHU de Bordeaux & INSERM, Université de Bordeaux, France|