Lassa Fever Clinical Trials

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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Liberia
Phebe Hospital
NOT_YET_RECRUITING
Suacoco
Nigeria
Abubakar Tafawa Balewa University Teaching Hospital
NOT_YET_RECRUITING
Bauchi
Irrua Specialist Teaching Hospital
RECRUITING
Irrua
Federal Medical Center Owo
RECRUITING
Owo
Contact Information
Primary
Camille FRITZELL, PHD
camille.fritzell@coral.alima.ngo
+33 6 58 80 90 12
Backup
Sylvain JUCHET
sylvain.juchet@coral.alima.ngo
+33 6 58 80 90 12
Time Frame
Start Date: 2025-05-02
Estimated Completion Date: 2027-06
Participants
Target number of participants: 1755
Treatments
Experimental: Favipiravir 1600
Oral favipiravir: 2400 mg BID D1; 1600 mg BID D2-D10
Active_comparator: Ribavirin
Intravenous ribavirin (Irrua regimen - 100 mg/kg Day 1 (dose is divided: 2/3 stat, 1/3 8 hours later, maximum dose is 7g/day) then 25 mg/kg single dose days 2-7, 12.5 mg/kg single dose days 8-10).
Experimental: Favipiravir 1200 + ribavirin
Oral favipiravir: 2400 mg BID D1; 1200 mg BID D2-D10 Intravenous ribavirin (Irrua regimen - 100 mg/kg Day 1 (dose is divided: 2/3 stat, 1/3 8 hours later, maximum dose is 7g/day) then 25 mg/kg single dose days 2-7, 12.5 mg/kg single dose days 8-10).
Experimental: Ribavirin + dexamethasone
IV ribavirin, Irrua regimen IV or oral dexamethasone 6mg/day (For the first 48 hours, dexamethasone will be given intravenously (i. Afterwards, a switch to oral dexamethasone (same dosage) is permitted at the discretion of the study physician.)
Experimental: ARN-75039 high dose
• ARN-75039 high dose~* D1: 300mg (morning), 200mg (evening)~* D2: 200mg BID~* D3-10: 100mg BID
Experimental: ARN-75039 low dose
• ARN-75039 low dose~* D1: 150mg (morning), 100mg (evening)~* D2: 100mg BID~* D3-10: 50mg BID
Related Therapeutic Areas
Sponsors
Collaborators: Bernhard Nocht Institute for Tropical Medicine, Médecins Sans Frontières, Belgium, Alliance for International Medical Action, ANRS, Emerging Infectious Diseases, University of Bordeaux, University of Hamburg-Eppendorf, Phebe Hospital, Liberia, Centre de Recherche Médicale de Lambaréné, University of North Carolina, Federal Medical Centre, Owo, Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire, Donka Hospital, Conakry, Fondation pour la Recherche Scientifique, Benin, Alex Ekwueme Federal University Teaching Hospital
Leads: Irrua Specialist Teaching Hospital

This content was sourced from clinicaltrials.gov