NCT06212336 ISTH/ANRS 0409s INTEGRATE Lassa Fever Study
| NCT ID | NCT06212336 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Irrua Specialist Teaching Hospital |
| Condition | Lassa Fever |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,755 participants |
| Start Date | 2025-05-02 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 1,755 participants in total. It began in 2025-05-02 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
1. General Inclusion criteria * 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 Exclusion criteria * 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 2. Sub-protocols 2.1 Favipiravir high dose sub-protocol Inclusion criteria • Age ≥ 18 years old Exclusion criteria • 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) 2.2. Favipiravir-Ribavirin sub-protocol Inclusion criteria • Age ≥ 18 years old Exclusion criteria * 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) 2.3. Dexamethasone sub-protocol Inclusion criteria • Age ≥ 12 years old Exclusion criteria • 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 2.4 ARN-75039 subprotocols Exclusion criteria • History of severe gastrointestinal disease • History of chronic generalized pruritus * History of severe chronic liver disease * History of severe cardiac disorder
Contact & Investigator
Marie MD JASPARD, MD
STUDY DIRECTOR
ALIMA - The Alliance for International Medical Action - Paris, France
Frequently Asked Questions
Who can join the NCT06212336 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lassa Fever. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06212336 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06212336 currently recruiting?
Yes, NCT06212336 is actively recruiting participants. Contact the research team at camille.fritzell@coral.alima.ngo for enrollment information.
Where is the NCT06212336 trial being conducted?
This trial is being conducted at Suacoco, Liberia, Irrua, Nigeria, Owo, Nigeria, Bauchi, Nigeria.
Who is sponsoring the NCT06212336 clinical trial?
NCT06212336 is sponsored by Irrua Specialist Teaching Hospital. The principal investigator is Marie MD JASPARD, MD at ALIMA - The Alliance for International Medical Action - Paris, France. The trial plans to enroll 1,755 participants.