[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533200":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":67,"collaborators":26,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":26,"enrollmentInfo":79,"targetDuration":26,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":26,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Bernhard Nocht Institute for Tropical Medicine","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of care","ACTIVE_COMPARATOR","Standard of care antiviral ribavirin therapy",[13],"Drug: Ribavirin",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of care + dexamethasone","EXPERIMENTAL","Standard of care antiviral ribavirin therapy + dexamethasone",[19,13],"Drug: Dexamethasone",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Dexamethasone","Dexamethasone will be administered for 10 days. For the first 48 hours, dexamethasone will be given iv. After 48 hours, a switch to oral dexamethasone (same dosage) is permitted at the discretion of the study physician.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Ribavirin","Ribavirin treatment will be administered iv for 10 days, as recommended in the Nigeria Centre for Disease Control and Prevention National Guidelines for LF Case Management.",[9,15],[32],{"name":33,"affiliation":5,"role":34},"Stephan Günther, Prof.","STUDY_DIRECTOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Mirjam Groger, Dr.","CONTACT","+4940285380480","groger@bnitm.de",{"name":33,"role":38,"phone":42,"phoneExt":26,"email":43},"+4940285380547","guenther@bnitm.de",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Irrua Specialist Teaching Hospital","RECRUITING","Irrua","Edo","Nigeria","NG",{"type":53,"coordinates":54},"Point",[55,56],6.21984,6.73634,{"lat":56,"lon":55},[59,63],{"name":60,"role":38,"phone":61,"phoneExt":26,"email":62},"Sylvanus Okogbenin, Prof","+2348060476179","okogbenins@yahoo.co.uk",{"name":64,"role":38,"phone":65,"phoneExt":26,"email":66},"Cyril Erameh, Dr","+2348032413382","cyrilerameh@gmail.com",{"type":68,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100533200","phase-2-lassa-fever-adjunct-treatment-with-dexamethasone-100533200",false,"NCT06222723","LAssa Fever Adjunct Treatment With DEXamethasone","Safety and Tolerability of Adjunct Dexamethasone in Addition to Standard of Care Antiviral Therapy Compared to Standard of Care Antiviral Therapy Alone for the Treatment of Moderate to Severe Lassa Fever","LADEX","Inclusion Criteria:\n\n* Age ≥ 18 years\n* LF confirmed by RT-PCR (reverse-transcription polymerase chain reaction) with a cycle threshold (Ct) value \\\u003C 30\n* Signs of significant health impairment as evidenced by any of the following:\n* Alert, confusion, voice, pain, unresponsive (ACVPU) other than A\n* Systolic blood pressure \\\u003C 90 mmHg\n* Seizure(s), meningism, coma, focal neurological deficit\n* AST (GOT) \\>3xULN\n* ALT (GPT) \\> 3xULN\n* KDIGO 2 or more severe based on serum creatinine only\n* Active macroscopic bleeding\n* O2 saturation \\\u003C 92\n\nExclusion Criteria:\n\n* Pregnancy (evidenced by positive urine pregnancy test in women of child-bearing potential)\n* Lactation following live birth\n* Known intolerance and contra-indications to ribavirin or dexamethasone\n* Patients who already received a corticosteroid within the preceding 7 days\n* Investigator's valuation that patient might be put to substantial risk by participating in this trial\n* Patients receiving end-of-life care as judged by the investigator","ALL","18 Years",{"count":80,"type":81},42,"ESTIMATED","INTERVENTIONAL",[84],"PHASE2","Dexamethasone is a corticosteroid which can modulate inflammatory-mediated tissue damage associated with a wide range of infectious diseases. Dexamethasone is routinely used for treatment of tuberculous meningitis and for pneumococcal meningitis in adults. In Coronavirus Disease 2019 (COVID-19) dexamethasone is also effectively preventing immune mediated damage of the lungs. There is also indication that dexamethasone may be promising in severe LF.",[87],"Lassa Fever","2025-02-04",{"date":90,"type":91},"2025-02-06","ACTUAL",{"date":93,"type":91},"2024-02-05",{"date":95,"type":81},"2026-12",{"name":5,"class":6},1]