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

22-021

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

2023-07-12

2023-09-30

2023-12-31

Recruiting

Early phase I

24

Inclusion Criteria: 1. Adult in-patients (≥18 years) with laboratory confirmed CCHF infection by positive polymerase chain reaction (PCR) test. 2. Ability to provide informed consent signed by study patient or legally acceptable representative 3. 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. 4. Severity Grading System (SGS) for CCHF - mild/moderate. 5. Less than or equal to 7 days from onset of CCHF symptoms Exclusion Criteria: 1. Stage 4 severe chronic kidney disease or requiring dialysis (i.e., estimated glomerular filtration (eGFR) rate \<30 mL/min/1.73 m2) 2. Pregnant or breast feeding 3. Anticipated transfer to another hospital which is not a study site within 72 hours 4. Known Allergy to any study medication 5. Patients participating in another clinical trial of an investigational medicinal product (CTIMP) within the last 30 days. 6. Positive COVID-19 PCR 7. Previous intolerance of Favipiravir or Ribavirin 8. Haemoglobinopathies 9. Unstable cardiac diseases within 6 months 10. Any participants deemed not suitable, based on investigators opinion. 11. Patients taking the drugs listed in section 8.11 within 30 days or 5 times the half-life (whichever is longer) of enrolment

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ESTIMATED'}}

2023-10-05