[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582209":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":30,"locations":30,"responsibleParty":39,"collaborators":30,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":43,"sex":49,"minAge":50,"maxAge":30,"enrollmentInfo":51,"targetDuration":30,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":64,"whyStopped":30,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":30},{"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],{"type":40,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","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\nAdult in-patients (≥18 years)\n\nLaboratory confirmed CCHF infection by positive polymerase chain reaction (PCR) test within 5 days prior to randomisation\n\nCapacity to provide informed consent signed by study patient or legally acceptable representative (for illiterate individuals).\n\nWomen 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.\n\nSeverity Grading System (SGS) for CCHF - mild\u002Fmoderate.\n\nLess than or equal to 7 days from onset of CCHF symptoms\n\nWillingness to participate in the full protocol\n\nRequirement to be hospitalised for treatment-\n\nExclusion Criteria:\n\nStage 4 severe chronic kidney disease or requiring dialysis (i.e., estimated glomerular filtration (eGFR) rate \\\u003C30 mL\u002Fmin\u002F1.73 m2)\n\nPregnant or breast feeding\n\nAnticipated transfer to another hospital which is not a study site within 72 hours\n\nKnown Allergy to any study medication\n\nPatients participating in another clinical trial of an investigational medicinal product (CTIMP) within the last 30 days.\n\nPrevious intolerance of Favipiravir or Ribavirin\n\nAny participants deemed not suitable, based on investigators opinion.\n\nPatients taking the drugs listed below within 30 days or 5 times the half-life (whichever is longer) of enrolment:\n\nPyrazinamide: 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\nRepaglinide: 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\nTheophylline: 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\nFamciclovir, 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.\n\nParacetamol: Coadministration of paracetamol (650 mg once daily) and favipiravir (1200 mg twice daily or 800 mg twice daily) increased paracetamol Cmax and AUC by 3% and 16% (1200 mg doses) and by 8% and 14% (800 mg doses). In the UMIT-2 trial after screening and randomisation the daily dose of paracetamol in adults should be no more than 3000 mg\u002Fday (rather than 4000 mg\u002Fday) -","ALL","18 Years",{"count":52,"type":53},378,"ESTIMATED","INTERVENTIONAL",[56],"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",[59],"Crimean-Congo Hemorrhagic Fever",[61,27,62,63],"CCHF","Ribavirin","Crimean Congo Hemorrhagic Fever","NOT_YET_RECRUITING","2025-03-04",{"date":67,"type":68},"2025-03-06","ACTUAL",{"date":70,"type":53},"2025-07-01",{"date":72,"type":53},"2028-08-31",{"name":5,"class":6}]