ISTH/ANRS 0409s INTEGRATE Lassa Fever Study
Efficacy, Tolerability and Safety of New or Repurposed Drugs Against Lassa Fever in West African Countries
Irrua Specialist Teaching Hospital
1,755 participants
May 2, 2025
INTERVENTIONAL
Conditions
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.).
Eligibility
Inclusion Criteria6
- General
- Clinical disease with signs and symptoms suggestive for LF
- Positive plasma LASV RT-PCR
- Participant requires hospitalization per the local guidelines
- Participant or their legally authorized representative is able and willing to sign the informed consent
- Age ≥ 18 years old
Exclusion Criteria32
- 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
- Received drug therapy for Lassa fever (excluding supportive care) prior to inclusion
- Has received a vaccine against LF
- Sub-protocols
- 1 Favipiravir high dose sub-protocol
- Treatment contraindicated with favipiravir according to the Reference safety document
- Pre-existing liver failure
- Severe symptomatic gout/hyperuricemia
- History of QT prolongation or arrhythmia or other cardiac disorders
- PR interval ≥ 200 ms
- Hypersensitivity to excipients
- Inability to take oral drug (e.g. encephalopathy, severe vomiting)
- 2. Favipiravir-Ribavirin sub-protocol
- Pregnancy (evidenced by positive urine pregnancy test in women of child-bearing potential)
- Treatment contraindicated with favipiravir according to the Reference safety document
- Pre-existing liver failure
- Severe symptomatic gout/hyperuricemia
- History of QT prolongation or arrhythmia or other cardiac disorders
- PR interval ≥ 200 ms
- Hypersensitivity to excipients
- Inability to take oral drug (e.g. encephalopathy, severe vomiting)
- 3. Dexamethasone sub-protocol
- Pregnancy (evidenced by positive urine pregnancy test in women of child-bearing potential)
- Known intolerance and contra-indications to ribavirin or dexamethasone
- Patients who already received a corticosteroid within the preceding 7 days
- 4 ARN-75039 subprotocols
- History of chronic generalized pruritus
- History of severe chronic liver disease
- History of severe cardiac disorder
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Interventions
Interventional Medicinal Product (IMP)
Control arm
Interventional Medicinal Product (IMP)
Investigational Medicinal Product
Investigational Medicinal Product
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT06212336