Overview

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

Status:
Recruiting
Trial end date:
2022-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bernhard Nocht Institute for Tropical Medicine
Collaborators:
Alliance for International Medical Action
Federal Medical Centre, Owo
Institut National de la Santé Et de la Recherche Médicale, France
Irrua Specialist Teaching Hospital
University of Bordeaux
University of Hamburg
University of Hamburg-Eppendorf
Treatments:
Favipiravir
Ribavirin
Criteria
Inclusion Criteria:

- Age ≥ 18 years

- LF confirmed by RT-PCR (reverse-transcription polymerase chain reaction)

- Written informed consent

Exclusion Criteria:

- Inability to give consent (e.g. unconscious patients/ cognitively impaired patients)

- Pregnancy/lactation (evidenced by negative urine pregnancy test in women of
child-bearing potential)

- Women who plan to get pregnant within the upcoming 6 months

- Severe malnutrition (BMI<16)

- Known intolerance to ribavirin or favipiravir

- History of hemoglobinopathies (i.e., sickle-cell anaemia or thalassemia major) and/or
haemophilia

- Organ failure as evidenced by:

- Creatinine ≥ 3x upper limit of normal (ULN)

- Aspartate aminotransferase (AST/GOT) > 150 IU/l

- Alert, confusion, voice, pain, unresponsive (ACVPU) score = V or P or U
(corresponds to Glasgow Coma Scale (GCS) ≤ 12)

- Severe central nervous system features (e.g. seizures, restlessness, confusion
and coma)

- O2 Saturation < 90%

- Hematocrit <30 %

- Severe anaemia requiring blood transfusion

- Inability to take oral drug (e.g. encephalopathy, severe vomiting)

- Patients who already received ribavirin or favipiravir within the preceding 7 days