[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623890":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":34,"locations":40,"responsibleParty":101,"collaborators":11,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":11,"eligibilityCriteria":109,"healthyVolunteers":105,"sex":110,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":11,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":11,"overallStatus":43,"whyStopped":11,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Simcere Pharmaceutical Co., Ltd","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SIM0916","EXPERIMENTAL",null,[13],"Drug: SIM0916",{"label":15,"type":16,"description":11,"interventionNames":17},"SIM0916 Placebo","PLACEBO_COMPARATOR",[18],"Drug: SIM0916 Placebo",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","Dose: 20 mg\u002Fkg TID",[9],{"type":21,"name":15,"description":22,"armGroupLabels":25,"otherNames":11},[15],[27,31],{"name":28,"affiliation":29,"role":30},"hanmin liu","West China Second University Hospital","PRINCIPAL_INVESTIGATOR",{"name":32,"affiliation":33,"role":30},"lanjuan Li","Shulan (Hangzhou) Hospital",[35],{"name":36,"role":37,"phone":38,"phoneExt":11,"email":39},"zhibiao song","CONTACT","86-13641133681","songzhibiao@simcere.com",[41,59,73,88],{"facility":42,"status":43,"city":44,"state":45,"zip":11,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"The First Affiliated Hospital Of Xiamen University","RECRUITING","Xiamen","Fujian","China","CN",{"type":49,"coordinates":50},"Point",[51,52],118.08187,24.47979,{"lat":52,"lon":51},[55],{"name":56,"role":37,"phone":57,"phoneExt":11,"email":58},"Yungang Yang","86-0592-2137303","xmyyg@sina.com",{"facility":60,"status":43,"city":61,"state":62,"zip":11,"country":46,"countryCode":47,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Hunan Children's Hospital","Changsha","Hunan",{"type":49,"coordinates":64},[65,66],112.97087,28.19874,{"lat":66,"lon":65},[69],{"name":70,"role":37,"phone":11,"phoneExt":71,"email":72},"Yanping Chen","86-0731-853561","hnchengyanping@163.com",{"facility":74,"status":75,"city":76,"state":77,"zip":11,"country":46,"countryCode":47,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"West China Second University Hospital Sichuan University","NOT_YET_RECRUITING","Chengdu","Sichuan",{"type":49,"coordinates":79},[80,81],104.06667,30.66667,{"lat":81,"lon":80},[84],{"name":85,"role":37,"phone":86,"phoneExt":11,"email":87},"Hanmin Liu","(028) 85503960","Hanmin@vip.163.com",{"facility":89,"status":75,"city":90,"state":91,"zip":11,"country":46,"countryCode":47,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Shulan(hangzhou)Hospital","Hangzhou","Zhejiang",{"type":49,"coordinates":93},[94,95],120.16142,30.29365,{"lat":95,"lon":94},[98],{"name":32,"role":37,"phone":99,"phoneExt":11,"email":100},"86 571 87236456","ljli@zju.edu.cn",{"type":102,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100623890","phase-3-a-phase-iii-study-of-deuremidevir-hydrobromide-for-the-treatment-of-rsv-infection-in-infants-and-young-children-100623890",false,"NCT07402512","A Phase III Study of Deuremidevir Hydrobromide for the Treatment of RSV Infection in Infants and Young Children","A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Deurremidevir Hydrobromide for Oral Suspension in Infants and Young Children With Respiratory Syncytial Virus Infection","Inclusion Criteria:\n\n1. Infants and young children aged ≥ 1 month and ≤ 36 months, regardless of gender;\n2. Weight ≥ 2.5 kg and ≤ 20 kg;\n3. Positive RSV antigen or nucleic acid test\n4. Duration of illness due to RSV infection ≤ 96 hours;\n5. Presence of tachypnea and wheezing;\n6. Wang Bronchiolitis Score≥ 5;\n7. For subjects aged \\\u003C 12 months, head circumference should be within the normal range corresponding to their age and gender.\n\nExclusion Criteria:\n\n1. Subjects who have received protocol-specified prohibited medications:\n2. Subjects with severe intrapulmonary complications or extrapulmonary complications;\n3. Subjects requiring vasopressors or inotropic agents;\n4. Subjects with known concurrent SARS-CoV-2 infection, influenza virus infection, Mycoplasma infection, or suspected concurrent bacterial or other pathogen infections;\n5. Subjects with a known history of hypercapnia;\n6. Subjects with chronic or persistent feeding difficulties;\n7. Subjects with gastrointestinal diseases that the investigator believes may significantly affect the absorption of the study drug;\n8. Subjects with congenital metabolic abnormalities;\n9. Subjects with bronchopulmonary dysplasia requiring assisted ventilation or clinically significant congenital respiratory tract abnormalities;\n10. Subjects with congenital heart disease (CHD) that the investigator assesses may affect efficacy evaluation;\n11. Subjects with clinical evidence of hepatic decompensation; or abnormal liver function tests;\n12. Subjects with renal failure, including renal abnormalities potentially related to renal insufficiency or abnormal renal function tests;\n13. Subjects with a known history of HIV positivity, or suspected to be HIV positive by the investigator;\n14. Subjects with known or suspected primary immunodeficiency diseases or transplant recipients;\n15. Subjects with a history of epilepsy or febrile convulsions;\n16. Subjects with a personal or family history of severe allergies or allergies;\n17. Subjects with active or uncontrolled respiratory, cardiac, hepatic, central nervous system, or renal diseases, or other medical conditions deemed unsuitable for enrollment by the investigator;\n18. Subjects who participated in other drug or medical device clinical trials and received investigational products or devices;\n19. Subjects deemed unsuitable for participation in this study by the investigator for any other reason.","ALL","1 Month","36 Months",{"count":114,"type":115},498,"ESTIMATED","INTERVENTIONAL",[118],"PHASE3","This is a randomized, double-blind, placebo-controlled, parallel-group trial conducted in infants and young children aged 1 to 36 months with RSV infection.\n\nA total of 498 subjects are expected to be enrolled and randomly assigned to the investigational product group or the placebo group in a 2:1 ratio; Administration will be based on the subject's weight, with a dose of 20 mg\u002Fkg three times daily for 5 consecutive days (15 doses).",[121],"Respiratory Syncytial Virus Infection","2026-03-29",{"date":124,"type":125},"2026-04-02","ACTUAL",{"date":127,"type":125},"2026-03-11",{"date":129,"type":115},"2027-06-30",{"name":5,"class":6},4]