Crimean-Congo Hemorrhagic FeverPhase 2UMIT-2NCT06860334
UMIT-2 - Adaptive Phase IIb Platform Trial to Determine the Efficacy and Safety of Therapeutics for CCHF
A Phase 2 study testing Favipiravir and Ribavin in people with Crimean-Congo Hemorrhagic Fever, run by Liverpool School of Tropical Medicine at 3 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crimean-Congo Hemorrhagic Fever
- What is being tested?
- Favipiravir and Ribavin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 378 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 4 Jun 2026to 31 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)3 sites, 3 recruiting
- Recruiting
Atatürk University
Erzurum
Zülal Özkurt
- Recruiting
Ondokuz Mayıs University
Samsun
Ilkay Bozkurt
- Recruiting
Sivas Cumhuriyet University
Sivas
Nazif Elaldi
About this study
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
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
Read the detailed description
This will be a 1:1:1 randomised open-label phase 2b trial of Favipiravir (IV \& PO) and Ribavirin (IV \& PO) vs optimised standard of care in CCHF aimed at evaluating virological efficacy. This is an adaptive multi-arm Phase II platform for patients with CCHF. Key design features are:
Treatment arms can be added or removed.
Shared standard of care (SoC, control) arm so that a greater proportion of more patients receive experimental therapeutics. Eligibility to randomisation to specific treatment arms is based on treatment specific inclusion/exclusion criteria and all comparisons to SoC are within the same eligibility set and concurrent randomisation.
Timing of interim analyses flexible to make use of the seasonality of CCHF to ensure they take place during low recruitment periods.
- Conditions
- Crimean-Congo Hemorrhagic Fever
- Being tested
- Favipiravir, Ribavin, Optimised Standard of Care
- Keywords
- CCHF, Favipiravir, Ribavirin, Crimean Congo Hemorrhagic Fever
- Medical subject headings
- Hemorrhagic Fever, Crimean
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FavipiravirDrug
6-fluoro-3-hydroxypyrazine-2-carboxamide, T-705
RibavinDrug
1-3,4-dihydroxy-5-1,2,4-triazole-3-carboxamide
Optimised Standard of CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Optimised standard of care (oSOC) | Active comparator | 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. The standard of care arm will exclude any medicine defined as investigation arms of this study. Any supportive medication or therapies will be recorded on the patient CRFs. Receives: Other: Optimised Standard of Care |
| Arm B: Favipiravir | Active comparator | Day 1 (First 24 hours): IV Favipiravir 2600 mg twice daily (BD) Day 2 (24-48 hours): IV Favipiravir 1200 mg twice daily (BD) Day 3 -7 (Post 48 hours): Oral (PO) Favipiravir 1200 mg twice daily (BD)1 until hospital discharge up to 7 days (14 doses) whichever is soonest.
Plus any additional supportive care deemed necessary by the study investigator Receives: Drug: Favipiravir |
| Arm C: Ribavirin | Active comparator | Day 1 (First 24 hours): IV Ribavirin (33mg/kg) loading dose followed by IV Ribavirin 16mg/kg every 6 hours Day 2 (24-48 hours): IV Ribavirin 16mg/kg four times daily (QDS) Days 3-5: Oral (PO) Ribavirin 16mg/kg four times daily (QDS) Days 6 -7: Oral (PO) Ribavirin 8mg/kg four times daily (QDS) until hospital discharge
Plus any additional supportive care deemed necessary by the study investigator Receives: Drug: Ribavin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virologic objective: To compare CCHFV viral dynamics of investigational therapeutics relative to the control arm
Comparison of CCHFV viral load clearance by Day 5 for treatment arms compared to Standard of Care arm.
Measured: Day 5 from treatment start
Secondary outcomes (7)
Safety Objective: To determine the safety and tolerability of investigational therapeutics relative to the control arm
Comparison of incidence of serious adverse events in treatment arms compared to standard of care arm.
Comparison of the frequency and characterisation of clinically significant adverse events related to study agent administration
(Safety and Tolerability of Favipiravir and Ribavirin CTCAE v5 Grade ≥3 adverse events)
Measured: Day 29
Clinical Objective: To compare time to successful hospital discharge between participants receiving investigational therapeutics, relative to the control arm
Time from Randomisation to discharge from hospital
Measured: Day 29
Antiviral Objective: To evaluate antiviral efficacy of investigational therapeutics (1)
Comparison of CCHFV viral load reduction between for treatment arms compared to Standard of Care arm
Measured: Day 10
Antiviral Objective: To evaluate antiviral efficacy of investigational therapeutics (2)
Comparison of Viral load reduction by PCR test for treatment arms compared to Standard of Care arm
Measured: Day 10
Safety Objective: To compare the overall mortality in patients with CCHF who receive different investigational therapeutics with those who receive the control arm
Mortality at Days 14 and 28 (time from date of randomisation to death) for treatment arms compared to Standard of Care arm
Measured: Day 28
Safety Objective: To compare mortality rates among patients whose baseline predictors of disease place them in different categories for disease severity, who receive different investigational therapeutics.
Mortality at Days 14 and 28 (time from date of randomisation to death) in different SGS groups for treatment arms compared to Standard of Care arm
Measured: Day 28
Pharmacokinetic objective:To characterise the plasma pharmacokinetics (PK) of therapeutics in CCHF
To investigate the exposure-response relationship of Favipiravir on CCHF viral dynamics by analysing concentrations of investigation therapeutics in plasma
Measured: Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start4 Jun 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crimean-Congo Hemorrhagic FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1:1 randomised open-label phase 2b trial
- Masking
- None (open label)
- Enrolment
- 378 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool School of Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- MEDEX, Medical Research Council
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860334
- Sponsor's protocol ID
- 25-013
- Acronym
- UMIT-2
- Status last verified
- Aug 2026
- First submitted
- 13 Feb 2025
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06860334
- Acronym / sponsor ID
- UMIT-2 / 25-013
- Conditions
- Crimean-Congo Hemorrhagic Fever
- Keywords
- CCHF, Favipiravir, Ribavirin, Crimean Congo Hemorrhagic Fever
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 378 participants (estimated)
- Lead sponsor
- Liverpool School of Tropical MedicineUniversity, hospital or other
- Collaborators
- MEDEX, Medical Research Council
- Study start
- 4 Jun 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This will be a 1:1:1 randomised open-label phase 2b trial of Favipiravir (IV \& PO) and Ribavirin (IV \& PO) vs optimised standard of care in CCHF aimed at evaluating virological efficacy. This is an adaptive multi-arm Phase II platform for patients with CCHF. Key design features are:
Treatment arms can be added or removed.
Shared standard of care (SoC, control) arm so that a greater proportion of more patients receive experimental therapeutics. Eligibility to randomisation to specific treatment arms is based on treatment specific inclusion/exclusion criteria and all comparisons to SoC are within the same eligibility set and concurrent randomisation.
Timing of interim analyses flexible to make use of the seasonality of CCHF to ensure they take place during low recruitment periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 1:1:1 randomised open-label phase 2b trial
| Arm | Type | Receives |
|---|---|---|
| Optimised standard of care (oSOC) | Active comparator | Other: Optimised Standard of CareOptimised 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. The standard of care arm will exclude any medicine defined as investigation arms of this study. Any supportive medication or therapies will be recorded on the patient CRFs. |
| Arm B: Favipiravir | Active comparator | Drug: FavipiravirDay 1 (First 24 hours): IV Favipiravir 2600 mg twice daily (BD) Day 2 (24-48 hours): IV Favipiravir 1200 mg twice daily (BD) Day 3 -7 (Post 48 hours): Oral (PO) Favipiravir 1200 mg twice daily (BD)1 until hospital discharge up to 7 days (14 doses) whichever is soonest. Plus any additional supportive care deemed necessary by the study investigator |
| Arm C: Ribavirin | Active comparator | Drug: RibavinDay 1 (First 24 hours): IV Ribavirin (33mg/kg) loading dose followed by IV Ribavirin 16mg/kg every 6 hours Day 2 (24-48 hours): IV Ribavirin 16mg/kg four times daily (QDS) Days 3-5: Oral (PO) Ribavirin 16mg/kg four times daily (QDS) Days 6 -7: Oral (PO) Ribavirin 8mg/kg four times daily (QDS) until hospital discharge Plus any additional supportive care deemed necessary by the study investigator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Favipiravir6-fluoro-3-hydroxypyrazine-2-carboxamide, T-705 | Drug | Arm B: Favipiravir |
| Ribavin1-3,4-dihydroxy-5-1,2,4-triazole-3-carboxamide | Drug | Arm C: Ribavirin |
| Optimised Standard of CareOptimised 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. | Other | Optimised standard of care (oSOC) |
Primary outcome
Virologic objective: To compare CCHFV viral dynamics of investigational therapeutics relative to the control arm
Time frame: Day 5 from treatment start
Comparison of CCHFV viral load clearance by Day 5 for treatment arms compared to Standard of Care arm.
7 secondary outcomes
Safety Objective: To determine the safety and tolerability of investigational therapeutics relative to the control arm
Time frame: Day 29
Clinical Objective: To compare time to successful hospital discharge between participants receiving investigational therapeutics, relative to the control arm
Time frame: Day 29
Antiviral Objective: To evaluate antiviral efficacy of investigational therapeutics (1)
Time frame: Day 10
Antiviral Objective: To evaluate antiviral efficacy of investigational therapeutics (2)
Time frame: Day 10
Safety Objective: To compare the overall mortality in patients with CCHF who receive different investigational therapeutics with those who receive the control arm
Time frame: Day 28
Safety Objective: To compare mortality rates among patients whose baseline predictors of disease place them in different categories for disease severity, who receive different investigational therapeutics.
Time frame: Day 28
Pharmacokinetic objective:To characterise the plasma pharmacokinetics (PK) of therapeutics in CCHF
Time frame: Day 29
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Favipiravir and Ribavin in people with Crimean-Congo Hemorrhagic Fever, run by Liverpool School of Tropical Medicine at 3 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alex Hainsworth (0151 702 9460 ext. +44, UMIT@lstmed.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Virologic objective: To compare CCHFV viral dynamics of investigational therapeutics relative to the control arm (time frame: Day 5 from treatment start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.