Adaptive Phase IIb Platform Trial to Test Therapies for Crimean-Congo Hemorrhagic Fever
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
Run by Liverpool School of Tropical Medicine · NCT06860334 · Data updated 2026-11-12
A multi-arm, adaptive trial in adults with confirmed CCHF in Turkey and Iraq will test Favipiravir or Ribavirin against optimized standard care to see if these antivirals help clear the virus and improve outcomes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 378 (estimated) |
| Sponsor | Liverpool School of Tropical Medicine Academic / other |
| Locations | 3 sites (Erzurum and 2 other locations) |
| Status | Recruiting |
| Started | June 4, 2026 |
| Main results expected | December 30, 2027 |
| Study ends | August 31, 2028 |
| Registry record updated | August 7, 2026 |
| Trial ID | NCT06860334 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+ years) with lab-confirmed CCHF, hospitalized, within 7 days of symptom onset, able to provide consent, and using contraception as required.
✕Probably not a fit
Patients not benefiting may include those with severe renal impairment or those not meeting specific inclusion criteria or those who experience rapid progression despite treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
UMIT-2 is an adaptive, multi-arm Phase IIb trial designed to evaluate antiviral therapies for Crimean-Congo Hemorrhagic Fever. The study uses a shared control group and interim analyses to add or drop treatment arms based on ongoing results, aiming to identify virological efficacy while ensuring safety. Eligible participants are adults with laboratory-confirmed CCHF within 7 days of symptom onset, hospitalized and able to consent. Randomization is 1:1:1 across Favipiravir, Ribavirin, and optimized standard of care, with plan for flexible interim checks aligned to seasonal recruitment patterns. The trial is conducted across multiple sites in Türkiye and Iraq, led by the Liverpool School of Tropical Medicine with collaboration from MEDEX and the Medical Research Council.
Why it matters
Potential benefit: If successful, this trial could identify effective antiviral options to reduce viral load and improve clinical outcomes for people with CCHF.
How similar studies have gone: This is among the first large randomized trials of novel antivirals for CCHF using an adaptive platform design; prior evidence is limited and results are not yet established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult in-patients (≥18 years) at the time of screening. * Confirmed CCHF infection: Laboratory confirmed CCHF infection defined as positive polymerase chain reaction (PCR) test within 5 days prior to randomisation. * Ability to provide informed consent signed by study patient or legally acceptable representative (for illiterate individuals). * 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 Protocol section 5.4) from the first administration of trial treatment, throughout trial treatment and for the duration outlined. * Severity Grading System (SGS) for CCHF - Low/moderate risk. (Appendix 15). * Less than or equal to 7 days from onset of CCHF symptoms. * Willingness to participate in the full protocol. * Requirement to be hospitalised for treatment. Exclusion Criteria: * Severe renal impairment: Stage 4 severe chronic kidney disease or requiring dialysis (i.e., estimated glomerular filtration (eGFR) rate \<30 mL/min/1.73 m\^2). * 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. * Known hypersensitivity or allergy to any component of the investigational medicinal product (IMP) or its excipients or documented previous intolerance or significant adverse reaction to the active IMP. * Participation in another clinical trial involving an investigational medicinal product (CTIMP) within 30 days or five half-lives of the prior IMP (whichever is longer). * Any condition or circumstance which, in the opinion of the Investigator, would place the participant at undue risk, compromise safety, or interfere with trial participation or interpretation of results. * Severity Grading System (SGS) for CCHF - High risk (Appendix 15). * Patients taking the drugs listed below within 30 days or 5 times the half-life (whichever is longer) of enrolment: * Pyrazinamide: Pyrazinamide administration with favipiravir examined possible renal urate transporter interactions. Pyrazinamide increased blood uric acid levels 2 to 9 mg/dL over baseline. The addition of favipiravir increased blood uric acid levels 4 to 11 mg/dL over baseline, indicating a moderate additive effect. * Repaglinide: Favipiravir administration with repaglinide, an anti-diabetic agent that is extensively metabolized by CYP2C8 and CYP3A4, increased repaglinide plasma AUC 30 to 50% due to inhibition of CYP2C8. * Theophylline: Theophylline administration with favipiravir increases plasma Cmax and AUC of favipiravir through xanthine oxidase (XO) interaction. The primary metabolite of theophylline is known to be metabolized by XO which is partially involved in metabolism of favipiravir. * Famciclovir, Sulindac: Famciclovir and Sulindac are converted to active metabolite by Aldehyde Oxidase (AO). Favipiravir inhibits AO and decrease the concentration of active metabolite of Famciclovir and Sulindac.
Where it's running
-
Atatürk University
Erzurum, Turkey (Türkiye) Recruiting -
Ondokuz Mayıs University
Samsun, Turkey (Türkiye) Recruiting -
Sivas Cumhuriyet University
Sivas, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Alex Hainsworth
- Email: UMIT@lstmed.ac.uk
- Phone: 0151 702 9460
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Self-amplifying RNA vaccine for Crimean-Congo hemorrhagic fever in healthy adults
This will test whether different doses and a one- or two-dose schedule of the experimental HDT-321 vaccine are safe and trigger immune responses in healthy adults aged 18–64.
-
Rapid test to identify Crimean-Congo hemorrhagic fever at the point of care
A new rapid test is being tested to see if it can reliably detect Crimean-Congo hemorrhagic fever at the patient bedside in clinics in Turkey.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.