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NOT YET RECRUITING
NCT06860334
PHASE2

UMIT-2 - Adaptive Phase IIb Platform Trial to Determine the Efficacy and Safety of Therapeutics for CCHF

Sponsor: Liverpool School of Tropical Medicine

View on ClinicalTrials.gov

Summary

CCHF has a wide geographical distribution with cases mainly occurring in Asia, the Middle East, South-Eastern Europe and Africa. Since its emergence in 2002, Turkiye has been the epicentre of activity worldwide reporting up to more than 1000 cases annually. CCHF case management relies on the provision of optimised supportive care; therapeutic options lack a robust evidence base The UMIT-2 Trial (UMIT = 'Hope' in Turkish) will be the first large randomised controlled trial of novel therapeutics in CCHF, undertaken in multiple trial sites in Turkiye and Iraq. It uses an efficient adaptive platform design (Phase IIb), focussed on antiviral efficacy with interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety

Official title: UMIT-2: A Randomized, Multi-country, Adaptive Phase IIb Platform Trial to Determine the Efficacy and Safety of Therapeutics for Crimean-Congo Haemorrhagic Fever

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

378

Start Date

2025-07-01

Completion Date

2028-08-31

Last Updated

2025-03-06

Healthy Volunteers

No

Interventions

DRUG

Favipiravir

6-fluoro-3-hydroxypyrazine-2-carboxamide, T-705

DRUG

Ribavin

1-3,4-dihydroxy-5-1,2,4-triazole-3-carboxamide

OTHER

Optimised Standard of Care

Optimised standard of care will include treatment per national guidelines for CCHF case management in Turkiye and Iraq, and any other supportive medication or therapies as required.