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RECRUITING
NCT06212336
PHASE2/PHASE3

ISTH/ANRS 0409s INTEGRATE Lassa Fever Study

Sponsor: Irrua Specialist Teaching Hospital

View on ClinicalTrials.gov

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.).

Official title: Efficacy, Tolerability and Safety of New or Repurposed Drugs Against Lassa Fever in West African Countries

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1755

Start Date

2025-05-02

Completion Date

2027-06

Last Updated

2026-02-04

Healthy Volunteers

No

Conditions

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

Locations (4)

Phebe Hospital

Suacoco, Bong County, Liberia

Irrua Specialist Teaching Hospital

Irrua, Edo, Nigeria

Federal Medical Center Owo

Owo, Ondo State, Nigeria

Abubakar Tafawa Balewa University Teaching Hospital

Bauchi, Nigeria