Pharmacokinetics, Tolerability and Safety of Favipiravir Compared to Ribavirin for the Treatment of Lassa Fever

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.

Conditions

• Lassa Fever

Interventions

DRUG

Ribavirin iv

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 days 2-7, 12.5 mg/kg days 8-10

DRUG

Favipiravir

Day 1 2400mg(H0)-2400mg(H8)-1200mg(H16), Day 2-10 1200mg twice daily

Sponsors & Collaborators

• University of Hamburg-Eppendorf

  collaborator OTHER

• Alliance for International Medical Action

  collaborator OTHER

• Institut National de la Santé Et de la Recherche Médicale, France

  collaborator OTHER_GOV

• University of Bordeaux

  collaborator OTHER

• Federal Medical Centre, Owo

  collaborator INDUSTRY

• Irrua Specialist Teaching Hospital

  collaborator OTHER

• Bernhard Nocht Institute for Tropical Medicine

  lead OTHER_GOV

Principal Investigators

• Peter Akhideno, Dr · ISTH

• Sylvanus Okogbenin, Prof · ISTH

• Oluwafemi Ayodeji, Dr · FMCO

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-07-30

Primary Completion

2022-11-10

Completion

2022-11-17

Countries

• Nigeria

Study Locations