ISTH/ANRS 0409s INTEGRATE Lassa Fever Study

Summary

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.).

Conditions

• Lassa Fever

Interventions

DRUG

Favipiravir

Interventional Medicinal Product (IMP)

DRUG

Ribavirin

Control arm

DRUG

Dexamethasone

Interventional Medicinal Product (IMP)

DRUG

ARN-75039 high dose

Investigational Medicinal Product

DRUG

ARN-75039 low dose

Investigational Medicinal Product

Sponsors & Collaborators

• Alliance for International Medical Action

  collaborator OTHER

• University of Bordeaux

  collaborator OTHER

• Bernhard Nocht Institute for Tropical Medicine

  collaborator OTHER_GOV

• Federal Medical Centre, Owo

  collaborator INDUSTRY

• Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire

  collaborator OTHER

• Fondation pour la Recherche Scientifique, Benin

  collaborator UNKNOWN

• Médecins Sans Frontières, Belgium

  collaborator OTHER

• Alex Ekwueme Federal University Teaching Hospital

  collaborator OTHER

• Donka Hospital, Conakry

  collaborator UNKNOWN

• Centre de Recherche Médicale de Lambaréné

  collaborator OTHER

• University of Hamburg-Eppendorf

  collaborator OTHER

• Phebe Hospital, Liberia

  collaborator UNKNOWN

• University of North Carolina

  collaborator OTHER

• ANRS, Emerging Infectious Diseases

  collaborator OTHER_GOV

• Irrua Specialist Teaching Hospital

  lead OTHER

Principal Investigators

• Marie MD JASPARD, MD · ALIMA - The Alliance for International Medical Action - Paris, France

• Sylvanus OKOGBENIN, MD · Irrua Specialist Teaching Hospital Irrua - Edo State, Nigeria

• Michael RAMHARTER, MD · Bernhard Nocht Institute for Tropical Medicine Bernhard-Nocht-Hamburg, Germany

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-02

Primary Completion

2027-06-30

Completion

2027-06-30

FDA Drug

Yes

Countries

• Liberia
• Nigeria

Study Locations