NCT02739477

Brief Summary

This study aims to evaluate favipiravir high dose tolerance in male survivor of Ebola Virus Disease (EVD) with Ebola Virus (EBOV) RNA in semen. This is a dose escalation study with 3 cohorts of 6 patients, each dose level including 2 sentinel patients.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

February 24, 2016

Last Update Submit

February 20, 2025

Conditions

Ebola Virus Survivor

Keywords

FavipiravirToleranceSurvivorEbola VirusGenital reservoirGuinea

Outcome Measures

Primary Outcomes (1)

  • Number of patients undergoing grade 3 or 4 clinical or biological adverse events related to Favipiravir (Common Terminology Criteria for Adverse Events, CTCAE, v4.03)

    Day 1 is the first day of favipiravir intake

    Day 14

Secondary Outcomes (3)

  • Evolution of EBOV semen RNA and infectious loads

    Semen collection will be performed at least at Day 7, Day 14, Day 21 and Day 90

  • Plasma and semen trough concentrations of favipiravir

    Plasma collection at Day 3, Day7, Day 10 and Day 14. Semen collection at Day 7 and Day 14

  • Genetic variations associated with favipiravir exposition

    Blood collection at Day 1 will be used for further genotyping.

Study Arms (1)

Favipiravir

EXPERIMENTAL

Favipiravir (oral administration, 200 mg light yellow, round-shaped, coated divisible tablets that can be crushed and mixed with liquid)

Drug: Favipiravir

Interventions

FavipiravirDRUG

Cohort 1: Day 1 (inclusion) 4800 mg (2400 mg bid). Day 2 to Day 14: 3600 mg (1800 mg bid). Cohort 2: Day 1 (inclusion) 4800 mg (2400 mg bid). Day 2 to Day 14: 3600, 4200, 4800 mg per day depending on cohort 1 results. Cohort 3: Day 1 (inclusion) 4800 mg (2400 mg bid). Day 2 to Day 14: 3600, 4200, 4800 mg per day depending on cohorts 1 and 2 results.

Also known as: AVIGAN
Favipiravir

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male survivor of biologically confirmed EVD
  • age \>= 18 years
  • EBOV RT-PCR on semen with cycle threshold \[Ct\]\<38 at Day -7 and semen aliquot available for later quantification of EBOV
  • signed informed consent
  • EBOV RT-PCR on blood with cycle threshold \[Ct\]\<38 at Day -7
  • Biological abnormality higher than grade 2 according to CTCAE (v4.03) on following parameters: creatinine, ASAT, ALAT, alkaline phosphatase, total bilirubin
  • Fridericia corrected QT interval (QTc) \> 450 ms
  • Concomitant use of QT/QTc interval-prolonging drugs or drugs that could cause electrolyte imbalance, such as: loop diuretics, thiazide diuretics or related
  • Previous gout attack or ongoing treatment for gout or hyperuricemia
  • Ongoing pyrazinamide treatment or other drug known to induce hyperuricemia
  • Previous hypersensitivity reaction due to nucleoside analogue
  • Symptom or biological value suggesting systemic disorder (renal, hepatic, cardio-vascular, pulmonary) or any medical condition that could interfere with results interpretation or compromise participants' health
  • Explicit refusal to comply with proper use of drug (condom use)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Conakry

Conakry, Guinea

Location

Nzérékoré

Nzérékoré, Guinea

Location

Related Publications (1)

  • Eloy P, Laouenan C, Beavogui AH, Keita S, Manchon P, Etard JF, Sissoko D, Mentre F, Malvy D. High doses of favipiravir in two men survivors of Ebola virus disease carrying Ebola virus in semen in Guinea. IDCases. 2022 Jan 21;27:e01412. doi: 10.1016/j.idcr.2022.e01412. eCollection 2022.

    PMID: 35127447RESULT

MeSH Terms

Interventions

favipiravir

Study Officials

  • Daouda Sissoko, Doctor

    Inserm 897 unit, ISPED, Université de Bordeaux, Bordeaux cedex

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2016

First Posted

April 15, 2016

Study Start

April 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

February 24, 2025

Record last verified: 2025-02

Locations

GU(2)