Pharmacokinetics, Tolerability and Safety of Favipiravir Compared to Ribavirin for the Treatment … (NCT04907682) | Clinical Trial Compass
CompletedPhase 2
Pharmacokinetics, Tolerability and Safety of Favipiravir Compared to Ribavirin for the Treatment of Lassa Fever
Nigeria40 participantsStarted 2021-07-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pharmacokinetic parameter of favipiravir: Maximum plasma concentration (Cmax)
Timeframe: Day 1, Day 2, Day 4, Day 6, Day 7, Day 8 and Day 10 of the study conduct
2
Pharmacokinetic parameter of favipiravir: Time to maximum concentration (Tmax)
Timeframe: Day 1, Day 2, Day 4, Day 6, Day 7, Day 8 and Day 10 of the study conduct
3
Pharmacokinetic parameter of favipiravir: Area under the concentration-time curve (AUC)
Timeframe: Day 1, Day 2, Day 4, Day 6, Day 7, Day 8 and Day 10 of the study conduct
4
Pharmacokinetic parameter of favipiravir: Half life (T1/2)
Timeframe: Day 1, Day 2, Day 4, Day 6, Day 7, Day 8 and Day 10 of the study conduct
5
Proportion of drug related AEs and SAEs of both study treatments
Timeframe: throughout study completion (10 days per participant)
Trial details
NCT IDNCT04907682
SponsorBernhard Nocht Institute for Tropical Medicine