ISTH/ANRS 0409s INTEGRATE Lassa Fever Study

ConditionLassa Fever
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorIrrua Specialist Teaching Hospital

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

1,755 Participants
are divided into 6 treatment groups

6

Treatment groups

See 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