Efficacy of Favipiravir Against Ebola (JIKI)

• Register: ClinicalTrials.gov
• Last refreshed on: 28 November 2016
• Main ID: NCT02329054
• Date of registration: 16/12/2014
• Prospective Registration: No
• Primary sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Public title: Efficacy of Favipiravir Against Ebola (JIKI) JIKI
• Scientific title: Efficacy of Favipiravir in Reducing Mortality in Individuals With Ebola Virus Disease in Guinea
• Date of first enrolment: December 2014
• Target sample size: 126
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02329054
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Guinea

Contacts

• Name: Denis Malvy, Professor
• Affiliation: CHU de Bordeaux & INSERM, Université de Bordeaux, France

Key inclusion & exclusion criteria

Inclusion Criteria:

- age >1 year and weighting =10kg,

- EVD confirmed by a positive qualitative PCR test,

- signed informed consent (signed by the parents/adults guardians in case of minor
patient).

Non inclusion-criteria:

- pregnancy*,

- inability to take the drug (encephalopathy, severe vomiting). * Emergency use of
favipiravir in pregnant women outside of the trial is envisaged and under evaluation.

In this protocol, the investigators will refer to the following groups according to age
and duration of symptoms**:

- Group A1: adults with time between first symptoms and first dose of favipiravir =72h;

- Group A2: adults with time between first symptoms and first dose of favipiravir >72h;

- Group C: all children >1 year and weighting =10kg. Time of first symptom refers to
the time of the beginning of any symptom considered to be related to EVD. **Symptoms
to be considered will be: acute onset of fever, severe headache, myalgia, extreme
fatigue, vomiting, diarrhoea, abdominal pain, or unexplained hemorrhage.

The division in groups is a matter of analysis, and will not be perceptible by the
patients during the trial process. Patients in the three groups will receive the same
treatment and will be followed under the same procedures, with only two exceptions: the
number of additional blood sample collections will be lower in group A2 and C (n=2) than
in group A1 (n=3) and daily dosages will be adapted to the body weight in group C.



Age minimum: 1 Year
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Ebola Virus Disease

Intervention(s)

Drug: Favipiravir

Primary Outcome(s)

Mortality [Time Frame: Day-14]

Secondary Outcome(s)

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

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

Mortality [Time Frame: Day-14 according to the second group definition (AC1, AC2, YC)]

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]

Criteria for cure [Time Frame: Day-30]

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

Secondary ID(s)

C14-63

Source(s) of Monetary Support

Please refer to primary and secondary sponsors