[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558494":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":49,"centralContacts":54,"locations":63,"responsibleParty":113,"collaborators":115,"id":121,"slug":122,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":123,"sex":129,"minAge":130,"maxAge":12,"enrollmentInfo":131,"targetDuration":12,"studyType":134,"phases":135,"briefSummary":137,"conditions":138,"keywords":12,"overallStatus":82,"whyStopped":12,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"Oxford University Clinical Research Unit, Vietnam","OTHER",[8,13,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of care (arm A)","NO_INTERVENTION","Patients, who are randomly allocated into arm A will receive the standard of care (no study drug)",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Molnupiravir (arm B)","EXPERIMENTAL","Patients, who are randomly allocated into arm B, will receive 800mg po bid of Molnupiravir for 5 days",[18],"Drug: Molnupiravir 400 mg",{"label":20,"type":15,"description":21,"interventionNames":22},"Monoclonal antibody (arm C)","Patients, who are randomly allocated into arm C, will receive a single dose of 6mg\u002FKg of the dengue monoclonal antibody via an intravenous line over 2 hours.",[23],"Drug: VIS513 (a monoclonal antibody)",{"label":25,"type":15,"description":26,"interventionNames":27},"Remdesivir (arm D)","Patients, who are randomly allocated into arm D, will receive:\n\n* Adults or children ≥ 40Kg: 200mg loading dose on day 1, followed by 100mg once daily from day 2 to day 5.\n* Children \\\u003C 40Kg: 5mg\u002FKg loading dose on day 1, followed by 2.5mg\u002FKg once daily from day 2 to day 5.",[28],"Drug: Remdesivir 100mg",[30,37,43],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Molnupiravir 400 mg","This is an antiviral drug (an RNA dependent RNA polymerase inhibitor, with broad spectrum antiviral activity) currently approved for use in treatment for COVID-19 patients.\n\nIn this trial, its antiviral effectiveness on the early phase of dengue virus infection will be assessed.",[14],[36],"Molnupiravir STELLA 400mg",{"type":31,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"VIS513 (a monoclonal antibody)","VIS513 is an engineered humanised monoclonal antibody produced by recombinant DNA technology in a mammalian cell (i.e. Chinese hamster ovary) line. It was discovered in the USA by Visterra Inc and subsequently technology for manufacturing and further development was transferred to Serum Institute of India Pvt. Ltd., Pune, India. It has shown potent, specific neutralization of all four serotypes of DENV.",[20],[42],"Dengue monoclonal antibody (Dengue mAb\u002F Dv Mab)",{"type":31,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Remdesivir 100mg","Remdesivir (GS-443902) is a nucleoside analogue - RNA dependent RNA polymerase inhibitor. In a meta-analysis of 10 RCTs and 32 observational studies reporting on the use of Remdesivir in COVID-19, remdesivir reduced mortality from severe disease and shortened time to clinical improvement. In this trial, its antiviral effectiveness on the early phase of dengue virus infection will be assessed",[25],[48],"VEKLURY™ for IV Infusion 100 mg",[50],{"name":51,"affiliation":52,"role":53},"Sophie Yacoub, MD., PhD.","University of Oxford, UK","PRINCIPAL_INVESTIGATOR",[55,59],{"name":51,"role":56,"phone":57,"phoneExt":12,"email":58},"CONTACT","+84 77728736","syacoub@oucru.org",{"name":60,"role":56,"phone":61,"phoneExt":12,"email":62},"Clinical Trials Unit Oxford University Clinical Research Unit","+84 28 3924 1983","CTU-Ethics@oucru.org",[64,80],{"facility":65,"status":66,"city":67,"state":12,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Universiti Malaya Medical Centre","NOT_YET_RECRUITING","Kuala Lumpur","59100","Malaysia","MY",{"type":72,"coordinates":73},"Point",[74,75],101.68653,3.1412,{"lat":75,"lon":74},[78],{"name":79,"role":56,"phone":12,"phoneExt":12,"email":12},"Hang Cheng Ong, Doctor",{"facility":81,"status":82,"city":83,"state":12,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Hospital for Tropical Diseases, Ho Chi Minh city","RECRUITING","Ho Chi Minh City","700000","Vietnam","VN",{"type":72,"coordinates":88},[89,90],106.62965,10.82302,{"lat":90,"lon":89},[93,95,96,99,101,103,105,107,109,111],{"name":94,"role":56,"phone":12,"phoneExt":12,"email":12},"Lan TH Nguyen, Doctor",{"name":94,"role":53,"phone":12,"phoneExt":12,"email":12},{"name":97,"role":98,"phone":12,"phoneExt":12,"email":12},"Trieu T Huynh, Doctor","SUB_INVESTIGATOR",{"name":100,"role":98,"phone":12,"phoneExt":12,"email":12},"Tho V Phan, Doctor",{"name":102,"role":98,"phone":12,"phoneExt":12,"email":12},"Huy X Vo, Doctor",{"name":104,"role":98,"phone":12,"phoneExt":12,"email":12},"Huong TC Nguyen, Doctor",{"name":106,"role":98,"phone":12,"phoneExt":12,"email":12},"Phong T Nguyen, Doctor",{"name":108,"role":98,"phone":12,"phoneExt":12,"email":12},"Vien TD Tran, Doctor",{"name":110,"role":98,"phone":12,"phoneExt":12,"email":12},"Men TH Pham, Doctor",{"name":112,"role":98,"phone":12,"phoneExt":12,"email":12},"Quy T Vo, Doctor",{"type":114,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[116,118],{"name":117,"class":6},"Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam",{"name":119,"class":120},"University Malaya Medical Centre, Malaysia","UNKNOWN","100558494","phase-2-adaptive-dengue-antiviral-platform-trial-100558494",false,"NCT06551844","Adaptive Dengue Antiviral Platform Trial","Adaptive Dengue Antiviral Platform Trial (ADAPT): a Phase 2 Randomized, Adaptive, Open Label Trial for Antiviral Screening in Patients With Early Symptomatic Dengue","ADAPT","Inclusion Criteria:\n\n* Female or male patients with a clinical diagnosis of dengue virus infection and less than 48 hours of fever\n* Positive NS1 rapid diagnostic test\n* \\>= 10 years or ≥ 18 years of age (depending on license of therapeutic being evaluated)\n* Patient is able to give written informed consent or assent for full participation in the study.\n* Agreement to stay in hospital for duration of the intervention (most will be 5 days) and follow-up visits at day 30 and 60 post enrolment.\n\nExclusion Criteria:\n\n* Meets criteria for severe dengue at baseline (severe plasma leakage leading to dengue shock syndrome, fluid accumulation with respiratory distress, severe bleeding, severe organ involvement - AST\u002FALT\\>1000 U\u002FL, impaired consciousness, multiple organ dysfunction)\n* Pregnancy (either clinically confirmed or by urine dipstick for human chorionic gonadotrophin hormone)\n* Breastfeeding women\n* Localising features suggesting an alternative\u002Fadditional diagnosis, e.g. pneumonia, sepsis\n* Renal failure (baseline eGFR \\\u003C 30ml\u002Fmin)\n* History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, neuropsychiatric, autoimmune, dermatologic or immunosuppressive disorders\n* History of allergic disease, allergic reactions or known hypersensitivity to any component of the study product (Mild non-medication allergies allowed)\n* Any condition that, in the opinion of the investigator, would complicate or compromise the study or well-being of the participant\n* Participation or planned participation in a study involving the administration of an investigational compound within the past one month.","ALL","10 Years",{"count":132,"type":133},500,"ESTIMATED","INTERVENTIONAL",[136],"PHASE2","This is a randomized, open-label adaptive platform trial aiming to screen the antiviral effectiveness of the experimental drug(s) in early dengue infection\n\n* Primary objectives:\n\n  * To determine the antiviral effectiveness of the experimental drug(s) in early dengue infection\n  * To assess the safety and tolerability of the experimental drug(s) in dengue patients\n* Secondary objective:\n\n  * To assess the effect of the experimental drug(s) in dengue patients on physiological, clinical and virological parameters",[139,140],"Dengue","Antiviral Drugs","2026-04-24",{"date":143,"type":144},"2026-04-30","ACTUAL",{"date":146,"type":144},"2026-04-20",{"date":148,"type":133},"2030-12-31",{"name":5,"class":6},2]