drugset / Trial / NCT04907682
Pharmacokinetics, Tolerability and Safety of Favipiravir Compared to Ribavirin for the Treatment of Lassa Fever
Phase 2
Completed
40 enrolled
Bernhard Nocht Institute for Tropical Medicine
Alliance for International Medical Action · collabFederal Medical Centre, Owo · collabInstitut National de la Santé Et de la Recherche Médicale, France · collabIrrua Specialist Teaching Hospital · collabUniversity of Bordeaux · collabUniversity of Hamburg-Eppendorf · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This exploratory, prospective, controlled, multisite, open label, randomized clinical trial with two treatment arms aims to compare favipiravir, a new treatment candidate for Lassa fever (LF), with the current standard of care, ribavirin. The primary endpoints of this research are (1) the description of classical pharmacokinetic parameters of favipiravir in comparison with ribavirin standard treatment in patients suffering from LF and (2) the safety and tolerability of both study drugs in the investigated regimens.
Timeline
- Start
- 2021-07-30
- Primary completion
- 2022-11-10
- Completion
- 2022-11-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Favipiravir | Small molecule | 1200 mg | Oral |
| Comparator | Ribavirin | Small molecule | 25 mg/kg | Intravenous |