Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
NCT06212336

ISTH/ANRS 0409s INTEGRATE Lassa Fever Study

Led by Irrua Specialist Teaching Hospital · Updated on 2026-02-04

1755

Participants Needed

4

Research Sites

108 weeks

Total Duration

On this page

Sponsors

I

Irrua Specialist Teaching Hospital

Lead Sponsor

A

Alliance for International Medical Action

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

ISTH/ANRS 0409s INTEGRATE Lassa Fever Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical disease with signs and symptoms suggestive for Lassa fever
  • Positive plasma LASV RT-PCR
  • Participant requires hospitalization per local guidelines
  • Ability and willingness of participant or legally authorized representative to sign informed consent
  • Age 18 years or older for Favipiravir sub-protocols
  • Age 12 years or older for Dexamethasone sub-protocol
Not Eligible

You will not qualify if you...

  • Unwilling to provide informed consent
  • Positive pregnancy test
  • History of allergic reaction or contraindication to ribavirin
  • Received drug therapy for Lassa fever (excluding supportive care) before inclusion
  • Previous vaccination against Lassa fever
  • For Favipiravir sub-protocols: treatment contraindicated with Favipiravir, pre-existing liver failure, severe gout or hyperuricemia, history of QT prolongation or arrhythmia or cardiac disorders, PR interval ≥ 200 ms, hypersensitivity to excipients, inability to take oral drug
  • For Dexamethasone sub-protocol: known intolerance or contraindications to ribavirin or dexamethasone, corticosteroid use within preceding 7 days
  • For ARN-75039 sub-protocols: history of severe gastrointestinal disease, chronic generalized pruritus, severe chronic liver disease, severe cardiac disorder

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 4 locations

1

Phebe Hospital

Suacoco, Bong County, Liberia

Not Yet Recruiting

2

Irrua Specialist Teaching Hospital

Irrua, Edo, Nigeria

Actively Recruiting

3

Federal Medical Center Owo

Owo, Ondo State, Nigeria

Actively Recruiting

4

Abubakar Tafawa Balewa University Teaching Hospital

Bauchi, Nigeria

Not Yet Recruiting

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Research Team

C

Camille FRITZELL, PHD

CONTACT

S

Sylvain JUCHET

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

6

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