[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582209":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":39,"locations":46,"responsibleParty":84,"collaborators":86,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":94,"sex":100,"minAge":101,"maxAge":30,"enrollmentInfo":102,"targetDuration":30,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":49,"whyStopped":30,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Liverpool School of Tropical Medicine","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Other: Optimised Standard of Care",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm B: Favipiravir","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.\n\nPlus any additional supportive care deemed necessary by the study investigator",[18],"Drug: Favipiravir",{"label":20,"type":10,"description":21,"interventionNames":22},"Arm C: Ribavirin","Day 1 (First 24 hours): IV Ribavirin (33mg\u002Fkg) loading dose followed by IV Ribavirin 16mg\u002Fkg every 6 hours Day 2 (24-48 hours): IV Ribavirin 16mg\u002Fkg four times daily (QDS) Days 3-5: Oral (PO) Ribavirin 16mg\u002Fkg four times daily (QDS) Days 6 -7: Oral (PO) Ribavirin 8mg\u002Fkg four times daily (QDS) until hospital discharge\n\nPlus any additional supportive care deemed necessary by the study investigator",[23],"Drug: Ribavin",[25,31,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Favipiravir","6-fluoro-3-hydroxypyrazine-2-carboxamide, T-705",[15],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Ribavin","1-3,4-dihydroxy-5-1,2,4-triazole-3-carboxamide",[20],{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Optimised Standard of Care","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.",[9],[40],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Alex Hainsworth","CONTACT","0151 702 9460","+44","UMIT@lstmed.ac.uk",[47,62,73],{"facility":48,"status":49,"city":50,"state":30,"zip":30,"country":51,"countryCode":30,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Atatürk University","RECRUITING","Erzurum","Turkey (Türkiye)",{"type":53,"coordinates":54},"Point",[55,56],41.27694,39.90861,{"lat":56,"lon":55},[59],{"name":60,"role":61,"phone":30,"phoneExt":30,"email":30},"Zülal Özkurt","PRINCIPAL_INVESTIGATOR",{"facility":63,"status":49,"city":64,"state":30,"zip":30,"country":51,"countryCode":30,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Ondokuz Mayıs University","Samsun",{"type":53,"coordinates":66},[67,68],36.3361,41.27976,{"lat":68,"lon":67},[71],{"name":72,"role":61,"phone":30,"phoneExt":30,"email":30},"Ilkay Bozkurt",{"facility":74,"status":49,"city":75,"state":30,"zip":30,"country":51,"countryCode":30,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Sivas Cumhuriyet University","Sivas",{"type":53,"coordinates":77},[78,79],37.01611,39.74833,{"lat":79,"lon":78},[82],{"name":83,"role":61,"phone":30,"phoneExt":30,"email":30},"Nazif Elaldi",{"type":85,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[87,89],{"name":88,"class":6},"MEDEX",{"name":90,"class":91},"Medical Research Council","OTHER_GOV","100582209","phase-2-umit-2---adaptive-phase-iib-platform-trial-to-determine-the-efficacy-and-safety-of-therapeutics-for-cchf-100582209",false,"NCT06860334","UMIT-2 - Adaptive Phase IIb Platform Trial to Determine the Efficacy and Safety of Therapeutics for CCHF","UMIT-2: A Randomized, Multi-country, Adaptive Phase IIb Platform Trial to Determine the Efficacy and Safety of Therapeutics for Crimean-Congo Haemorrhagic Fever","UMIT-2","Inclusion Criteria:\n\n* Adult in-patients (≥18 years) at the time of screening.\n* Confirmed CCHF infection: Laboratory confirmed CCHF infection defined as positive polymerase chain reaction (PCR) test within 5 days prior to randomisation.\n* Ability to provide informed consent signed by study patient or legally acceptable representative (for illiterate individuals).\n* 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.\n* Severity Grading System (SGS) for CCHF - Low\u002Fmoderate risk. (Appendix 15).\n* Less than or equal to 7 days from onset of CCHF symptoms.\n* Willingness to participate in the full protocol.\n* Requirement to be hospitalised for treatment.\n\nExclusion Criteria:\n\n* Severe renal impairment: Stage 4 severe chronic kidney disease or requiring dialysis (i.e., estimated glomerular filtration (eGFR) rate \\\u003C30 mL\u002Fmin\u002F1.73 m\\^2).\n* Pregnant or breast feeding.\n* Anticipated transfer to another hospital which is not a study site within 72 hours.\n* Known Allergy to any study medication.\n* Patients participating in another clinical trial of an investigational medicinal product (CTIMP) within the last 30 days.\n* 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.\n* 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).\n* 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.\n* Severity Grading System (SGS) for CCHF - High risk (Appendix 15).\n* Patients taking the drugs listed below within 30 days or 5 times the half-life (whichever is longer) of enrolment:\n\n  * Pyrazinamide: Pyrazinamide administration with favipiravir examined possible renal urate transporter interactions. Pyrazinamide increased blood uric acid levels 2 to 9 mg\u002FdL over baseline. The addition of favipiravir increased blood uric acid levels 4 to 11 mg\u002FdL over baseline, indicating a moderate additive effect.\n  * 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.\n  * 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.\n  * 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.","ALL","18 Years",{"count":103,"type":104},378,"ESTIMATED","INTERVENTIONAL",[107],"PHASE2","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\n\nThe 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",[110],"Crimean-Congo Hemorrhagic Fever",[112,27,113,114],"CCHF","Ribavirin","Crimean Congo Hemorrhagic Fever","2026-08-04",{"date":117,"type":118},"2026-08-07","ACTUAL",{"date":120,"type":118},"2026-06-04",{"date":122,"type":104},"2028-08-31",{"name":5,"class":6},3]