New treatment options for hospitalized people with Lassa fever in West Africa
Efficacy, Tolerability and Safety of New or Repurposed Drugs Against Lassa Fever in West African Countries
This trial will try several antiviral and supportive drugs to see which works best to prevent death or organ failure in people hospitalized with confirmed Lassa fever.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1755 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Irrua Specialist Teaching Hospital Academic / other |
| Locations | 4 sites (Suacoco, Bong County and 3 other locations) |
| Trial ID | NCT06212336 on ClinicalTrials.gov |
What this trial studies
INTEGRATE is a multinational, multicentre, randomized, open-label platform that moves seamlessly from phase II to phase III to compare multiple investigational drugs against standard of care in hospitalized Lassa fever patients. Participants are randomized to one of several arms including favipiravir, ribavirin, dexamethasone, or high- and low-dose ARN-75039, with outcomes compared to the local standard-of-care drug. The primary outcome is prevention of death or organ failure, while secondary work includes safety, virology, biological markers, and pharmacokinetic/pharmacodynamic modelling to guide dosing. The trial is conducted at participating hospitals in West Africa with coordination among academic and clinical partners.
Who should consider this trial
Good fit: Hospitalized adolescents and adults with PCR-confirmed Lassa fever who meet local hospitalization criteria and can provide informed consent (or have a legally authorized representative) are eligible.
Not a fit: People who are pregnant, have contraindications to the study drugs, have already received specific anti-Lassa drug therapy before enrollment, or have received an LF vaccine are unlikely to benefit from joining this trial.
Why it matters
Potential benefit: If successful, the trial could identify safer and more effective treatments that reduce deaths and organ failure from Lassa fever.
How similar studies have performed: Ribavirin is the only widely used treatment but has limited and uncertain evidence, while antivirals like favipiravir and ARN-75039 have shown promise in preclinical work and small studies but lack definitive phase II/III proof in humans.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Suacoco, Bong County and 3 other locations
- Phebe Hospital — Suacoco, Bong County, Liberia (Not_yet_recruiting)
- Irrua Specialist Teaching Hospital — Irrua, Edo, Nigeria (Recruiting)
- Federal Medical Center Owo — Owo, Ondo State, Nigeria (Recruiting)
- Abubakar Tafawa Balewa University Teaching Hospital — Bauchi, Nigeria (Not_yet_recruiting)
Study contacts
- Principal investigator: Sylvanus OKOGBENIN, MD — Irrua Specialist Teaching Hospital Irrua - Edo State, Nigeria
- Study coordinator: Camille FRITZELL, PHD
- Email: camille.fritzell@coral.alima.ngo
- Phone: +33 6 58 80 90 12
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.