Status:
COMPLETED
Pharmacokinetics, Tolerability and Safety of Favipiravir Compared to Ribavirin for the Treatment of Lassa Fever
Lead Sponsor:
Bernhard Nocht Institute for Tropical Medicine
Collaborating Sponsors:
University of Hamburg-Eppendorf
Alliance for International Medical Action
Conditions:
Lassa Fever
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 th...
Detailed Description
The currently used antiviral for the treatment of LF, which is also recommended by the World Health Organization (WHO) and the Nigeria Center for Disease Control, is ribavirin. However, evidence for r...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- LF confirmed by RT-PCR (reverse-transcription polymerase chain reaction)
- Written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
July 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04907682
Start Date
July 30 2021
End Date
November 17 2022
Last Update
February 8 2023
Active Locations (2)
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1
Irrua Specialist Teaching Hospital
Irrua, Edo, Nigeria
2
Federal Medical Center of Owo
Owo, Ondo State, Nigeria