CCHFPhase 1/2UMIT-1NCT05940545
UMIT-1 Trial Favipiravir & Ribavirin for the Treatment of CCHF
A Phase 1/2 study testing Favipiravir and Ribavirin in people with CCHF, run by Liverpool School of Tropical Medicine at 1 site in Turkey (Türkiye).
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CCHF
- What is being tested?
- Favipiravir and Ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jul 2023to 31 Dec 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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) with laboratory confirmed CCHF infection by positive polymerase chain reaction (PCR) test.
- Ability to provide informed consent signed by study patient or legally acceptable representative
- 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.
- Severity Grading System (SGS) for CCHF - mild/moderate.
- Less than or equal to 7 days from onset of CCHF symptoms
Who cannot join
- Stage 4 severe chronic kidney disease or requiring dialysis (i.e., estimated glomerular filtration (eGFR) rate <30 mL/min/1.73 m2)
- 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.
- Positive COVID-19 PCR
Show all 11Show fewer
- Previous intolerance of Favipiravir or Ribavirin
- Haemoglobinopathies
- Unstable cardiac diseases within 6 months
- Any participants deemed not suitable, based on investigators opinion.
- Patients taking the drugs listed in section 8.11 within 30 days or 5 times the half-life (whichever is longer) of enrolment
Trial locations and contacts
1 site in 1 country.
Umit-1 Study contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Oncology Training and Research Center
Ankara, Yenimahalle, 06200
Mustafa Ertek, ertekmustafa@hotmail.com
Mehmet Yildiz, mehmet.yildiz@medex-smo.com
About this study
Official title: 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
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
Read the detailed description
This will be a 2:1 randomised open-label phase I trial of IV Favipiravir and IV Favipiravir plus Ribavirin vs optimised standard of care in CCHF. The phase Ib will be carried out to test the safety and tolerability of IV Favipiravir in hospitalised patients. Following review of safety, tolerability and PK data from evaluated phase I doses, an IV Favipiravir doses will be selected to progress to phase II. virological efficacy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FavipiravirDrug
Small molecule antiviral
RibavirinDrug
Small molecule antiviral
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Active comparator | 6 patients will be randomised to starting dose of favipiravir 1800 mg BD (day 1), then 800mg BD Day 2 to 10, or standard of care. Receives: Drug: Favipiravir |
| Cohort 2 | Active comparator | 6 patients will be randomised to starting dose of favipiravir 2600 mg BD (day 1), then 1200mg BD day 2 to 10, or standard of care. Receives: Drug: Favipiravir |
| Cohort 3 | Active comparator | 6 patients will be randomised to starting dose of favipiravir 1800 mg BD (day 1), then 800mg BD Day 2 to 10 plus Ribavirin, or standard of care. Receives: Drug: Favipiravir; Drug: Ribavirin |
| Cohort 4 | Active comparator | 6 patients will be randomised to starting dose of favipiravir 2600mg BD (day 1), then 1200mg BD day 2 to 10 plus Ribavirin, or standard of care. Receives: Drug: Favipiravir; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety objective To determine the safety and tolerability of multiple doses of IV Favipiravir in patients with CCHF
Adverse events and serious adverse events
Dose limiting toxicities (Safety and Tolerability of IV Favipiravir and IV Favipiravir/Ribavirin- CTCAE v5 Grade ≥3 adverse events)
Measured: Up to day 8
To determine the safety and tolerability of multiple doses of IV Favipiravir in combination with Ribavirin in patients with CCHF
Adverse events and serious adverse events
Dose limiting toxicities (Safety and Tolerability of IV Favipiravir and IV Favipiravir/Ribavirin- CTCAE v5 Grade ≥3 adverse events)
Measured: up to day 8
Secondary outcomes (4)
Pharmacokinetic objective: To characterise the plasma pharmacokinetics of multiple doses of IV Favipiravir and IV Favipiravir in combination with Ribavirin
Evaluation of favipiravir in VHFs is limited by the predicted high-pill burden (up to 30 tablets per day) required and uncertainty around dose and PK.
Favipiravir injection (IV favipiravir) is a novel formulation of favipiravir for intravenous drip infusion, with Cmax levels 4-fold higher following administration of multiple doses in cynomolgus monkeys compared to oral (Toyama IB).
The favipiravir activity is derived from the intracellular ribofuranosyl-5'-triphosphate (RTP) metabolite that has a longer half-life intracellularly than the parent drug in plasma. Therefore, transiently higher Cmax values are expected to translate into sustained higher intracellular RTP concentrations and thus activity.
Measured: up to Day 8
Virologic objective
To investigate the effect of IV Favipiravir alone and in combination with Ribavirin on CCHF viral load
Measured: Change from baseline over time, up to Day 29, in viral load
Clinical objective
To investigate the ability of IV Favipiravir and in combination with Ribavirin to reduce the duration of signs and symptoms of CCHF in-patients.
Measured: Mortality at Days 15 and 29
Clinical objective
To investigate the ability of IV Favipiravir and in combination with Ribavirin to reduce the duration of signs and symptoms of CCHF in-patients.
Measured: Time from randomisation to death (up to day 29)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start12 Jul 2023
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CCHFStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool School of Tropical Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucy E Read, PhD, MRCP, Study director, Liverpool School of Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940545
- Sponsor's protocol ID
- 22-021
- Acronym
- UMIT-1
- Status last verified
- Jun 2023
- First submitted
- 3 May 2023
- Last updated
- 5 Oct 2023
- 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 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05940545
- Acronym / sponsor ID
- UMIT-1 / 22-021
- Conditions
- CCHF
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Liverpool School of Tropical MedicineUniversity, hospital or other
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 11 Jul 2023 (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.
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
Detailed description
This will be a 2:1 randomised open-label phase I trial of IV Favipiravir and IV Favipiravir plus Ribavirin vs optimised standard of care in CCHF. The phase Ib will be carried out to test the safety and tolerability of IV Favipiravir in hospitalised patients. Following review of safety, tolerability and PK data from evaluated phase I doses, an IV Favipiravir doses will be selected to progress to phase II. virological efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Active comparator | Drug: Favipiravir6 patients will be randomised to starting dose of favipiravir 1800 mg BD (day 1), then 800mg BD Day 2 to 10, or standard of care. |
| Cohort 2 | Active comparator | Drug: Favipiravir6 patients will be randomised to starting dose of favipiravir 2600 mg BD (day 1), then 1200mg BD day 2 to 10, or standard of care. |
| Cohort 3 | Active comparator | Drug: Favipiravir, Drug: Ribavirin6 patients will be randomised to starting dose of favipiravir 1800 mg BD (day 1), then 800mg BD Day 2 to 10 plus Ribavirin, or standard of care. |
| Cohort 4 | Active comparator | Drug: Favipiravir, Drug: Ribavirin6 patients will be randomised to starting dose of favipiravir 2600mg BD (day 1), then 1200mg BD day 2 to 10 plus Ribavirin, or standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult in-patients (≥18 years) with laboratory confirmed CCHF infection by positive polymerase chain reaction (PCR) test.
- Ability to provide informed consent signed by study patient or legally acceptable representative
- 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.
- Severity Grading System (SGS) for CCHF - mild/moderate.
- Less than or equal to 7 days from onset of CCHF symptoms
Key exclusion criteria (11 listed)
- Stage 4 severe chronic kidney disease or requiring dialysis (i.e., estimated glomerular filtration (eGFR) rate <30 mL/min/1.73 m2)
- 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 |
|---|---|---|
| FavipiravirSmall molecule antiviral | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| RibavirinSmall molecule antiviral | Drug | Cohort 3, Cohort 4 |
Primary outcome
Safety objective To determine the safety and tolerability of multiple doses of IV Favipiravir in patients with CCHF
Time frame: Up to day 8
Adverse events and serious adverse events Dose limiting toxicities (Safety and Tolerability of IV Favipiravir and IV Favipiravir/Ribavirin- CTCAE v5 Grade ≥3 adverse events)
To determine the safety and tolerability of multiple doses of IV Favipiravir in combination with Ribavirin in patients with CCHF
Time frame: up to day 8
Adverse events and serious adverse events Dose limiting toxicities (Safety and Tolerability of IV Favipiravir and IV Favipiravir/Ribavirin- CTCAE v5 Grade ≥3 adverse events)
4 secondary outcomes
Pharmacokinetic objective: To characterise the plasma pharmacokinetics of multiple doses of IV Favipiravir and IV Favipiravir in combination with Ribavirin
Time frame: up to Day 8
Virologic objective
Time frame: Change from baseline over time, up to Day 29, in viral load
Clinical objective
Time frame: Mortality at Days 15 and 29
Clinical objective
Time frame: Time from randomisation to death (up to day 29)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
Related trials for CCHF
RecruitingPhase 2
UMIT-2 - Adaptive Phase IIb Platform Trial to Determine the Efficacy and Safety of Therapeutics for CCHF
Crimean-Congo Hemorrhagic Fever
Recruiting
Development Of A Rapid Diagnostic Test To Identify Crimean-Congo Haemorrhagic Fever At The Point-Of-Care
Crimean-Congo Haemorrhagic Fever
RecruitingPhase 1
Safety and Immunogenicity of a Self-Amplifying RNA Vaccine Against Crimean-Congo Hemorrhagic Fever
Vaccine, Crimean-Congo Hemorrhagic Fever
Not yet recruiting
Serological Measurement of Montpellier Professionals' Contacts with Infectious Agents Responsible for Animal-borne Diseases
Leishmaniasis, Leptospirosis
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. This study is not recruiting at the moment.
Umit-1 Study contact
Lucy E Read, PhD, MRCP study director
Liverpool School of Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Favipiravir and Ribavirin in people with CCHF, run by Liverpool School of Tropical Medicine at 1 site 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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucy Read (+447743438383, lucy.read@lstmed.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety objective To determine the safety and tolerability of multiple doses of IV Favipiravir in patients with CCHF (time frame: Up to day 8). The study lists 2 primary outcomes in all. 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 5 Oct 2023.