About this trial
Lassa fever (LF) is a viral haemorrhagic fever responsible of 5000 deaths per year in West Africa, with in-hospital mortality at 12%. Transmission to humans occurs mainly via direct or indirect exposure to excreta from the rodent reservoir, mainly made up of Mastomys natalensis . Less frequently, LASV may also be transmitted from human to human and cause nosocomial outbreaks. Ribavirin is the only treatment available with worrying toxicity, questionable efficacy and low access because of its high cost. Consequently, there is an urgent need for new drugs to treat LF patients. The Research and Development (R\&D) Blueprint of the World Health Organization (WHO) has included LF in the list of priority diseases for urgent research and development.
The INTEGRATE consortium is an unprecedented international collaboration on Lassa fever of 15 partners from 10 countries across West Africa, Europe and North America and across several disciplines (epidemiological researchers, social scientists, medical health facility professionals, humanitarian actors, etc.).
Eligibility criteria
Qualifiers
General
Clinical disease with signs and symptoms suggestive for LF
Positive plasma LASV RT-PCR
Participant requires hospitalization per the local guidelines
Disqualifiers
Unwilling to provide informed consent
Positive pregnancy test
Unwilling to provide informed consent
History of allergic reaction or other contra-indication to ribavirin according to the Reference safety document
Trial design
Treatments tested in this trial
- Favipiravir
- Ribavirin
- Dexamethasone
- ARN-75039 high dose
- ARN-75039 low dose
Treatment groups
6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Irrua Specialist Teaching Hospital
Lead sponsor
Alliance for International Medical Action
Collaborator
University of Bordeaux
Collaborator
Bernhard Nocht Institute for Tropical Medicine
Collaborator
Federal Medical Centre, Owo
Collaborator
Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire
Collaborator
Fondation pour la Recherche Scientifique, Benin
Collaborator
Médecins Sans Frontières, Belgium
Collaborator
Alex Ekwueme Federal University Teaching Hospital
Collaborator
Donka Hospital, Conakry
Collaborator
Centre de Recherche Médicale de Lambaréné
Collaborator
University of Hamburg-Eppendorf
Collaborator
Phebe Hospital, Liberia
Collaborator
University of North Carolina
Collaborator
ANRS, Emerging Infectious Diseases
Collaborator