NCT05940545

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

UMIT-1 Trial: Favipiravir & Ribavirin Phase IB A Randomised Phase Ib Study to Determine the Phase II Dose and to Evaluate the Safety and Efficacy of Intravenous (IV) Favipiravir & Ribavirin

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Liverpool School of Tropical Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This will be a 2:1 randomised open-label phase I trial of IV Favipiravir and IV Favipiravir plus Ribavirin vs optimised standard of care in CCHF. The phase Ib will be carried out to test the safety and tolerability of IV Favipiravir in hospitalised patients. Following review of safety, tolerability and PK data from evaluated phase I doses, an IV Favipiravir doses will be selected to progress to phase II. virological efficacy.

Conditions

• CCHF

Interventions

Type	Name	Description
DRUG	Favipiravir	Small molecule antiviral
DRUG	Ribavirin	Small molecule antiviral

Timeline

• Start date: 2023-07-12
• Primary completion: 2023-09-30
• Completion: 2023-12-31
• First posted: 2023-07-11
• Last updated: 2023-10-05

Locations

1 site across 1 country: Turkey (Türkiye)