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Clinical trial

Pharmacokinetics, Tolerability and Safety of Favipiravir Compared to Ribavirin for the Treatment of Lassa Fever: A Randomized Controlled Open Label Phase II Clinical Trial

ID
Name
SAFARI
Description
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.
Trial arms
Trial start
2021-07-30
Estimated PCD
2022-11-10
Trial end
2022-11-17
Status
Completed
Phase
Early phase I
Treatment
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
Arms:
Intravenous ribavirin
Other names:
Irrua regimen
Favipiravir
Day 1 2400mg(H0)-2400mg(H8)-1200mg(H16), Day 2-10 1200mg twice daily
Arms:
Oral favipiravir
Other names:
Avigan
Size
40
Primary endpoint
Pharmacokinetic parameter of favipiravir: Maximum plasma concentration (Cmax)
Day 1, Day 2, Day 4, Day 6, Day 7, Day 8 and Day 10 of the study conduct
Pharmacokinetic parameter of favipiravir: Time to maximum concentration (Tmax)
Day 1, Day 2, Day 4, Day 6, Day 7, Day 8 and Day 10 of the study conduct
Pharmacokinetic parameter of favipiravir: Area under the concentration-time curve (AUC)
Day 1, Day 2, Day 4, Day 6, Day 7, Day 8 and Day 10 of the study conduct
Pharmacokinetic parameter of favipiravir: Half life (T1/2)
Day 1, Day 2, Day 4, Day 6, Day 7, Day 8 and Day 10 of the study conduct
Proportion of drug related AEs and SAEs of both study treatments
throughout study completion (10 days per participant)
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Exploratory, prospective, controlled, multisite, open label, randomized clinical trial with two arms', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}
Updated at
2023-02-08

1 organization

2 products

1 indication

Organization
Bernhard Nocht Institute for Tropical Medicine
Product
Ribavirin
Indication
Lassa fever
Product
Favipiravir