Treatment of CCHF with Favipiravir and Ribavirin
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
This study is testing if the medications Favipiravir alone or with Ribavirin can help adults with mild to moderate CCHF infection feel better compared to standard care.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Liverpool School of Tropical Medicine Academic / other |
| Locations | 1 site (Ankara, Yenimahalle) |
| Trial ID | NCT05940545 on ClinicalTrials.gov |
What this trial studies
The UMIT-1 trial is a randomized open-label study designed to evaluate the safety and efficacy of intravenous Favipiravir alone and in combination with Ribavirin for treating patients with confirmed CCHF infection. This trial will involve adult in-patients who have mild to moderate symptoms and will assess the tolerability of these treatments compared to optimized standard care. The study will first establish a safe dosage in Phase I before progressing to Phase II to evaluate virological efficacy.
Who should consider this trial
Good fit: Ideal candidates are adult in-patients aged 18 and older with laboratory-confirmed CCHF infection and mild to moderate symptoms.
Not a fit: Patients with severe chronic kidney disease or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from CCHF.
How similar studies have performed: While this approach is novel for CCHF, similar antiviral treatments have shown promise in other viral infections.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ankara, Yenimahalle
- Ankara Oncology Training and Research Center — Ankara, Yenimahalle, Turkey (Recruiting)
Study contacts
- Study coordinator: Lucy Read
- Email: lucy.read@lstmed.ac.uk
- Phone: +447743438383
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.