Pharmacokinetics, Tolerability and Safety of Favipiravir Compared to Ribavirin for the Treatment of Lassa Fever
SAFARI
2 other identifiers
interventional
40
1 country
2
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 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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2021
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2021
CompletedFirst Posted
Study publicly available on registry
June 1, 2021
CompletedStudy Start
First participant enrolled
July 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 17, 2022
CompletedFebruary 8, 2023
November 1, 2022
1.3 years
May 6, 2021
February 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Pharmacokinetic parameter of favipiravir: Maximum plasma concentration (Cmax)
Maximum plasma concentration (Cmax) of favipiravir
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)
Time to maximum concentration (Tmax) of favipiravir
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)
Area under the concentration-time curve (AUC) of favipiravir
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)
Half life (T1/2) of favipiravir
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
Safety and tolerability of ribavirin and favipiravir in investigated regimens by investigating the proportion of drug related AEs and SAEs
throughout study completion (10 days per participant)
Secondary Outcomes (7)
Mutagenicity
10 days
Change from baseline in Viral RNA loads
Day of enrollment - Day 10
Change from baseline in Lassa virus titers
Day of enrollment - Day 10
Change from baseline in Lassa virus serological status
10 days
Pharmacokinetic (PK) modelling and simulations
Day 1, Day 2, Day 4, Day 6, Day 7, Day 8 and Day 10 of the study conduct
- +2 more secondary outcomes
Study Arms (2)
Intravenous ribavirin
ACTIVE COMPARATORstandard treatment: Irrua regimen * 100 mg/kg Day 1 (dose is divided: 2/3 stat, 1/3 8 hours later, maximum dose is 7g/day) * 25 mg/kg days 2-7 * 12.5 mg/kg days 8-10
Oral favipiravir
EXPERIMENTALOral favipiravir * Day 1 2400mg(H0)-2400mg(H8)-1200mg(H16) * Day 2-10 1200mg twice daily (BD)
Interventions
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
Day 1 2400mg(H0)-2400mg(H8)-1200mg(H16), Day 2-10 1200mg twice daily
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- LF confirmed by RT-PCR (reverse-transcription polymerase chain reaction)
- Written informed consent
You may not qualify if:
- 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)
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bernhard Nocht Institute for Tropical Medicinelead
- University of Hamburg-Eppendorfcollaborator
- Alliance for International Medical Actioncollaborator
- Institut National de la Santé Et de la Recherche Médicale, Francecollaborator
- University of Bordeauxcollaborator
- Federal Medical Centre, Owocollaborator
- Irrua Specialist Teaching Hospitalcollaborator
Study Sites (2)
Irrua Specialist Teaching Hospital
Irrua, Edo, Nigeria
Federal Medical Center of Owo
Owo, Ondo State, Nigeria
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Akhideno, Dr
ISTH
- PRINCIPAL INVESTIGATOR
Sylvanus Okogbenin, Prof
ISTH
- PRINCIPAL INVESTIGATOR
Oluwafemi Ayodeji, Dr
FMCO
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2021
First Posted
June 1, 2021
Study Start
July 30, 2021
Primary Completion
November 10, 2022
Study Completion
November 17, 2022
Last Updated
February 8, 2023
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
- Time Frame
- From the time of publication and for a period which is aligned with the data sharing agreements approved by the research ethics committees of the counties/sites participating in the trial.
- Access Criteria
- This IPD shall be made available via a request and evaluation process to investigators whose proposed research has received inistitutional review board (IRB) approval. All investigators to whom this IPD is made available will be required to be part of the execution of a data use agreement. The data shall be made available through a governed data access process which includes a transparent, accountability and decision-making process: Completion of data request form Evaluation by a data access committee Data sharing Agreement Secure transfer of data
In line with the funding conditions, individual participant data (IPD) is to be shared. However, this will be de-identified IPD that used to generate the results reported (text, tables, figures and appendices). IPD sharing will begin after publication of primary results and will be available for a period which is aligned with the data sharing agreements approved by the research ethics committees of the counties/sites participating in the trial. The IPD shall be made available via a request and evaluation process to investigators whose proposed research has received IRB approval. All investigators to whom this IPD is made available will be required to be part of the execution of a data use agreement.