UMIT-1 Trial Favipiravir & Ribavirin for the Treatment of CCHF

NCT05940545 | Unknown Phase 1 DMC

• 1 other identifier: 22-021
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

UMIT-1: A Randomised Phase Ib Study to Determine the Phase II dose and to Evaluate the Safety and Efficacy of intravenous (IV) Favipiravir \& Ribavirin for the Treatment of CCHF

Conditions

CCHF

Outcome Measures

Primary Outcomes (2)

• Safety objective To determine the safety and tolerability of multiple doses of IV Favipiravir in patients with CCHF

  Adverse events and serious adverse events Dose limiting toxicities (Safety and Tolerability of IV Favipiravir and IV Favipiravir/Ribavirin- CTCAE v5 Grade ≥3 adverse events)

  Up to day 8

• To determine the safety and tolerability of multiple doses of IV Favipiravir in combination with Ribavirin in patients with CCHF

  Adverse events and serious adverse events Dose limiting toxicities (Safety and Tolerability of IV Favipiravir and IV Favipiravir/Ribavirin- CTCAE v5 Grade ≥3 adverse events)

  up to day 8

Secondary Outcomes (4)

• Pharmacokinetic objective: To characterise the plasma pharmacokinetics of multiple doses of IV Favipiravir and IV Favipiravir in combination with Ribavirin

  up to Day 8

• Virologic objective

  Change from baseline over time, up to Day 29, in viral load

• Clinical objective

  Mortality at Days 15 and 29

• Clinical objective

  Time from randomisation to death (up to day 29)

Other Outcomes (5)

• Pharmacokinetic objective: To investigate the exposure-response relationship of IV Favipiravir on CCHF viral dynamics.

  At End of study (6 Months)

• Pharmacokinetic objective: To investigate the exposure-response relationship of IV Favipiravir on CCHF viral dynamics.

  At End of study (6 Months)

• Pharmacokinetic objective: To characterise virus and host immune response.

  At End of study (6 Months)

Study Arms (4)

Cohort 1

ACTIVE COMPARATOR

6 patients will be randomised to starting dose of favipiravir 1800 mg BD (day 1), then 800mg BD Day 2 to 10, or standard of care.

Drug: Favipiravir

Cohort 2

ACTIVE COMPARATOR

6 patients will be randomised to starting dose of favipiravir 2600 mg BD (day 1), then 1200mg BD day 2 to 10, or standard of care.

Drug: Favipiravir

Cohort 3

ACTIVE COMPARATOR

6 patients will be randomised to starting dose of favipiravir 1800 mg BD (day 1), then 800mg BD Day 2 to 10 plus Ribavirin, or standard of care.

Drug: Favipiravir; Drug: Ribavirin

Cohort 4

ACTIVE COMPARATOR

6 patients will be randomised to starting dose of favipiravir 2600mg BD (day 1), then 1200mg BD day 2 to 10 plus Ribavirin, or standard of care.

Drug: Favipiravir; Drug: Ribavirin

Interventions

Favipiravir DRUG

Small molecule antiviral

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Ribavirin DRUG

Small molecule antiviral

Cohort 3; Cohort 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult in-patients (≥18 years) with laboratory confirmed CCHF infection by positive polymerase chain reaction (PCR) test.
• Ability to provide informed consent signed by study patient or legally acceptable representative
• Women of childbearing potential (WOCBP) and male patients who are sexually active with WOCBP must agree to use a highly effective method of contraception (as outlined in section 5.4 below) from the first administration of trial treatment, throughout trial treatment and for the duration outlined in trial protocol as well as addition 14 days for women and 7 days for men after the last dose of trial treatment.
• Severity Grading System (SGS) for CCHF - mild/moderate.
• Less than or equal to 7 days from onset of CCHF symptoms

You may not qualify if:

• Stage 4 severe chronic kidney disease or requiring dialysis (i.e., estimated glomerular filtration (eGFR) rate \<30 mL/min/1.73 m2)
• Pregnant or breast feeding
• Anticipated transfer to another hospital which is not a study site within 72 hours
• Known Allergy to any study medication
• Patients participating in another clinical trial of an investigational medicinal product (CTIMP) within the last 30 days.
• Positive COVID-19 PCR
• Previous intolerance of Favipiravir or Ribavirin
• Haemoglobinopathies
• Unstable cardiac diseases within 6 months
• Any participants deemed not suitable, based on investigators opinion.
• Patients taking the drugs listed in section 8.11 within 30 days or 5 times the half-life (whichever is longer) of enrolment

Sponsors & Collaborators

• Liverpool School of Tropical Medicine: lead

Study Sites (1)

Ankara Oncology Training and Research Center

Ankara, Yenimahalle, 06200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

favipiravir; Ribavirin

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Lucy E Read, PhD, MRCP

  Liverpool School of Tropical Medicine

  STUDY DIRECTOR

Central Study Contacts

Lucy Read

CONTACT

+447743438383; lucy.read@lstmed.ac.uk

Umit-1 Study

CONTACT

umit@lstmed.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: July 11, 2023
• Study Start: July 12, 2023
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-06

Locations

TU (1)