[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100532402":3},{"organization":4,"armGroups":7,"interventions":39,"overallOfficials":59,"centralContacts":72,"locations":81,"responsibleParty":152,"collaborators":154,"id":186,"slug":187,"hasResults":188,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":45,"eligibilityCriteria":192,"healthyVolunteers":188,"sex":193,"minAge":194,"maxAge":45,"enrollmentInfo":195,"targetDuration":45,"studyType":198,"phases":199,"briefSummary":202,"conditions":203,"keywords":205,"overallStatus":102,"whyStopped":45,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":220},{"fullName":5,"class":6},"Irrua Specialist Teaching Hospital","OTHER",[8,14,19,24,29,34],{"label":9,"type":10,"description":11,"interventionNames":12},"Favipiravir 1600","EXPERIMENTAL","Oral favipiravir: 2400 mg BID D1; 1600 mg BID D2-D10",[13],"Drug: Favipiravir",{"label":15,"type":16,"description":17,"interventionNames":18},"Ribavirin","ACTIVE_COMPARATOR","Intravenous ribavirin (Irrua regimen - 100 mg\u002Fkg Day 1 (dose is divided: 2\u002F3 stat, 1\u002F3 8 hours later, maximum dose is 7g\u002Fday) then 25 mg\u002Fkg single dose days 2-7, 12.5 mg\u002Fkg single dose days 8-10).",[13],{"label":20,"type":10,"description":21,"interventionNames":22},"Favipiravir 1200 + ribavirin","Oral favipiravir: 2400 mg BID D1; 1200 mg BID D2-D10 Intravenous ribavirin (Irrua regimen - 100 mg\u002Fkg Day 1 (dose is divided: 2\u002F3 stat, 1\u002F3 8 hours later, maximum dose is 7g\u002Fday) then 25 mg\u002Fkg single dose days 2-7, 12.5 mg\u002Fkg single dose days 8-10).",[13,23],"Drug: Ribavirin",{"label":25,"type":10,"description":26,"interventionNames":27},"Ribavirin + dexamethasone","IV ribavirin, Irrua regimen IV or oral dexamethasone 6mg\u002Fday (For the first 48 hours, dexamethasone will be given intravenously (i. Afterwards, a switch to oral dexamethasone (same dosage) is permitted at the discretion of the study physician.)",[23,28],"Drug: Dexamethasone",{"label":30,"type":10,"description":31,"interventionNames":32},"ARN-75039 high dose","• ARN-75039 high dose\n\n* D1: 300mg (morning), 200mg (evening)\n* D2: 200mg BID\n* D3-10: 100mg BID",[33],"Drug: ARN-75039 high dose",{"label":35,"type":10,"description":36,"interventionNames":37},"ARN-75039 low dose","• ARN-75039 low dose\n\n* D1: 150mg (morning), 100mg (evening)\n* D2: 100mg BID\n* D3-10: 50mg BID",[38],"Drug: ARN-75039 low dose",[40,46,51,54,57],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"DRUG","Favipiravir","Interventional Medicinal Product (IMP)",[20,9,15],null,{"type":41,"name":15,"description":47,"armGroupLabels":48,"otherNames":49},"Control arm",[20,25],[50],"Standard of care",{"type":41,"name":52,"description":43,"armGroupLabels":53,"otherNames":45},"Dexamethasone",[25],{"type":41,"name":30,"description":55,"armGroupLabels":56,"otherNames":45},"Investigational Medicinal Product",[30],{"type":41,"name":35,"description":55,"armGroupLabels":58,"otherNames":45},[35],[60,64,68],{"name":61,"affiliation":62,"role":63},"Marie MD JASPARD, MD","ALIMA - The Alliance for International Medical Action - Paris, France","STUDY_DIRECTOR",{"name":65,"affiliation":66,"role":67},"Sylvanus OKOGBENIN, MD","Irrua Specialist Teaching Hospital Irrua - Edo State, Nigeria","PRINCIPAL_INVESTIGATOR",{"name":69,"affiliation":70,"role":71},"Michael RAMHARTER, MD","Bernhard Nocht Institute for Tropical Medicine Bernhard-Nocht-Hamburg, Germany","STUDY_CHAIR",[73,78],{"name":74,"role":75,"phone":76,"phoneExt":45,"email":77},"Camille FRITZELL, PHD","CONTACT","+33 6 58 80 90 12","camille.fritzell@coral.alima.ngo",{"name":79,"role":75,"phone":76,"phoneExt":45,"email":80},"Sylvain JUCHET","sylvain.juchet@coral.alima.ngo",[82,101,119,134],{"facility":83,"status":84,"city":85,"state":86,"zip":45,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":94,"contacts":95},"Phebe Hospital","NOT_YET_RECRUITING","Suacoco","Bong County","Liberia","LR",{"type":90,"coordinates":91},"Point",[92,93],-9.58076,6.98992,{"lat":93,"lon":92},[96,100],{"name":97,"role":75,"phone":98,"phoneExt":45,"email":99},"Minnie Sankawulo-Ricks, Doctor","+231886 523 973","msricks126@gmail.com",{"name":97,"role":67,"phone":45,"phoneExt":45,"email":45},{"facility":5,"status":102,"city":103,"state":104,"zip":45,"country":105,"countryCode":106,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"RECRUITING","Irrua","Edo","Nigeria","NG",{"type":90,"coordinates":108},[109,110],6.21984,6.73634,{"lat":110,"lon":109},[113,117],{"name":114,"role":75,"phone":115,"phoneExt":45,"email":116},"Sylvanus Okogbenin, Professor","+2348060476179","okogbenins@yahoo.com",{"name":118,"role":67,"phone":45,"phoneExt":45,"email":45},"Cyril Erameh, Medical doctor",{"facility":120,"status":102,"city":121,"state":122,"zip":45,"country":105,"countryCode":106,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Federal Medical Center Owo","Owo","Ondo State",{"type":90,"coordinates":124},[125,126],5.58681,7.1962,{"lat":126,"lon":125},[129,133],{"name":130,"role":75,"phone":131,"phoneExt":45,"email":132},"Oladele Oluwafemi Ayodeji, Medical doctor","+2348035767632","femiayodeji@yahoo.com",{"name":130,"role":67,"phone":45,"phoneExt":45,"email":45},{"facility":135,"status":84,"city":136,"state":45,"zip":45,"country":105,"countryCode":106,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"Abubakar Tafawa Balewa University Teaching Hospital","Bauchi",{"type":90,"coordinates":138},[139,140],9.84388,10.31032,{"lat":140,"lon":139},[143,147,151],{"name":144,"role":75,"phone":145,"phoneExt":45,"email":146},"Yusuf Jibrin, Professor","+2348033940611","ybjibrin@yahoo.co.uk",{"name":148,"role":75,"phone":149,"phoneExt":45,"email":150},"Ibrahim Mahmood Maigari, Doctor","+2348061551992","immaigari@atbu.edu.ng",{"name":144,"role":67,"phone":45,"phoneExt":45,"email":45},{"type":153,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR",[155,157,159,162,165,167,170,172,174,176,178,180,182,184],{"name":156,"class":6},"Alliance for International Medical Action",{"name":158,"class":6},"University of Bordeaux",{"name":160,"class":161},"Bernhard Nocht Institute for Tropical Medicine","OTHER_GOV",{"name":163,"class":164},"Federal Medical Centre, Owo","INDUSTRY",{"name":166,"class":6},"Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire",{"name":168,"class":169},"Fondation pour la Recherche Scientifique, Benin","UNKNOWN",{"name":171,"class":6},"Médecins Sans Frontières, Belgium",{"name":173,"class":6},"Alex Ekwueme Federal University Teaching Hospital",{"name":175,"class":169},"Donka Hospital, Conakry",{"name":177,"class":6},"Centre de Recherche Médicale de Lambaréné",{"name":179,"class":6},"University of Hamburg-Eppendorf",{"name":181,"class":169},"Phebe Hospital, Liberia",{"name":183,"class":6},"University of North Carolina",{"name":185,"class":161},"ANRS, Emerging Infectious Diseases","100532402","phase-2-isthanrs-0409s-integrate-lassa-fever-study-100532402",false,"NCT06212336","ISTH\u002FANRS 0409s INTEGRATE Lassa Fever Study","Efficacy, Tolerability and Safety of New or Repurposed Drugs Against Lassa Fever in West African Countries","1. General\n\n   Inclusion criteria\n   * Clinical disease with signs and symptoms suggestive for LF\n   * Positive plasma LASV RT-PCR\n   * Participant requires hospitalization per the local guidelines\n   * Participant or their legally authorized representative is able and willing to sign the informed consent\n\n   Exclusion criteria\n   * Unwilling to provide informed consent\n   * Positive pregnancy test\n   * Unwilling to provide informed consent\n   * History of allergic reaction or other contra-indication to ribavirin according to the Reference safety document\n   * Received drug therapy for Lassa fever (excluding supportive care) prior to inclusion\n   * Has received a vaccine against LF\n2. Sub-protocols\n\n   2.1 Favipiravir high dose sub-protocol\n\n   Inclusion criteria • Age ≥ 18 years old\n\n   Exclusion criteria • Pregnancy (evidenced by positive urine pregnancy test in women of child-bearing potential)\n   * Treatment contraindicated with favipiravir according to the Reference safety document\n   * Pre-existing liver failure\n   * Severe symptomatic gout\u002Fhyperuricemia\n   * History of QT prolongation or arrhythmia or other cardiac disorders\n   * PR interval ≥ 200 ms\n   * Hypersensitivity to excipients\n   * Inability to take oral drug (e.g. encephalopathy, severe vomiting)\n\n   2.2. Favipiravir-Ribavirin sub-protocol\n\n   Inclusion criteria\n\n   • Age ≥ 18 years old\n\n   Exclusion criteria\n   * Pregnancy (evidenced by positive urine pregnancy test in women of child-bearing potential)\n   * Treatment contraindicated with favipiravir according to the Reference safety document\n   * Pre-existing liver failure\n   * Severe symptomatic gout\u002Fhyperuricemia\n   * History of QT prolongation or arrhythmia or other cardiac disorders\n   * PR interval ≥ 200 ms\n   * Hypersensitivity to excipients\n   * Inability to take oral drug (e.g. encephalopathy, severe vomiting)\n\n   2.3. Dexamethasone sub-protocol\n\n   Inclusion criteria • Age ≥ 12 years old\n\n   Exclusion criteria\n\n   • Pregnancy (evidenced by positive urine pregnancy test in women of child-bearing potential)\n\n   • Known intolerance and contra-indications to ribavirin or dexamethasone\n\n   • Patients who already received a corticosteroid within the preceding 7 days\n\n   2.4 ARN-75039 subprotocols\n\n   Exclusion criteria • History of severe gastrointestinal disease\n\n   • History of chronic generalized pruritus\n   * History of severe chronic liver disease\n   * History of severe cardiac disorder","ALL","18 Years",{"count":196,"type":197},1755,"ESTIMATED","INTERVENTIONAL",[200,201],"PHASE2","PHASE3","Lassa fever (LF) is a viral haemorrhagic fever responsible of 5000 deaths per year in West Africa, with in-hospital mortality at 12%. Transmission to humans occurs mainly via direct or indirect exposure to excreta from the rodent reservoir, mainly made up of Mastomys natalensis . Less frequently, LASV may also be transmitted from human to human and cause nosocomial outbreaks. Ribavirin is the only treatment available with worrying toxicity, questionable efficacy and low access because of its high cost. Consequently, there is an urgent need for new drugs to treat LF patients. The Research and Development (R\\&D) Blueprint of the World Health Organization (WHO) has included LF in the list of priority diseases for urgent research and development.\n\nThe INTEGRATE consortium is an unprecedented international collaboration on Lassa fever of 15 partners from 10 countries across West Africa, Europe and North America and across several disciplines (epidemiological researchers, social scientists, medical health facility professionals, humanitarian actors, etc.).",[204],"Lassa Fever",[206,207,208,209,210],"emerging infectious diseases","viral hemorrhagic fever","AFRICA","adult","adolescent","2026-02-02",{"date":213,"type":214},"2026-02-04","ACTUAL",{"date":216,"type":214},"2025-05-02",{"date":218,"type":197},"2027-06",{"name":5,"class":6},4]