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.).