[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611148":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":45,"locations":51,"responsibleParty":80,"collaborators":32,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":32,"eligibilityCriteria":88,"healthyVolunteers":85,"sex":89,"minAge":90,"maxAge":32,"enrollmentInfo":91,"targetDuration":32,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":73,"whyStopped":32,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Capital Medical University","OTHER",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Oseltamivir Arm","EXPERIMENTAL","All subjects will be randomized to receive suraxavir marboxil placebo (40mg on the first day) and oseltamivir (75mg each day during the first five days).",[13,14],"Drug: Oseltamivir","Drug: Suraxavir marboxil placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"suraxavir marboxil","All subjects will be randomized to receive oseltamivir placebo(75mg each day during the first five days) and suraxavir marboxil (40mg on the first day).",[19,13],"Drug: Suraxavir marboxil",{"label":21,"type":22,"description":23,"interventionNames":24},"Control Arm","PLACEBO_COMPARATOR","All subjects will be randomized to receive oseltamivir placebo(75mg each day during the first five days) and suraxavir marboxil placebo (40mg on the first day).",[25,14],"Drug: Oseltamivir Placebo",[27,33,37,41],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Suraxavir marboxil","Suraxavir marboxil (40mg on the first day)",[16],null,{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"Oseltamivir Placebo","Oseltamivir placebo(75mg each day during the first five days)",[21],{"type":28,"name":38,"description":39,"armGroupLabels":40,"otherNames":32},"Oseltamivir","Oseltamivir (75mg each day during the first five days)",[9,16],{"type":28,"name":42,"description":43,"armGroupLabels":44,"otherNames":32},"Suraxavir marboxil placebo","Suraxavir marboxil placebo (40mg on the first day).",[21,9],[46],{"name":47,"role":48,"phone":49,"phoneExt":32,"email":50},"Yeming Wang, Ph.D.","CONTACT","+86 84206264","wwyymm_love@163.com",[52,71],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"China-Japan Friendship hospital, Beijing, Beijing","NOT_YET_RECRUITING","Beijing","Beijing Municipality","100029","China","CN",{"type":61,"coordinates":62},"Point",[63,64],116.39723,39.9075,{"lat":64,"lon":63},[67],{"name":68,"role":48,"phone":69,"phoneExt":32,"email":70},"Bin Cao, Ph.D","8610-84206264","caobin_ben@163.com",{"facility":72,"status":73,"city":55,"state":56,"zip":32,"country":58,"countryCode":59,"cosmosGeoPoint":74,"geoPoint":76,"contacts":77},"China-Japan Friendship Hospital","RECRUITING",{"type":61,"coordinates":75},[63,64],{"lat":64,"lon":63},[78],{"name":79,"role":48,"phone":32,"phoneExt":32,"email":70},"Bin Cao",{"type":81,"investigatorFullName":79,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Professor","100611148","phase-3-suraxavir-marboxil-and-oseltamivir-for-influenza-prophylaxis-under-a-hospital-based-setting-100611148",false,"NCT07236814","Suraxavir Marboxil And Oseltamivir for Influenza Prophylaxis Under a Hospital-based Setting","1.Inclusion Criteria:\n\n(1)Inclusion Criteria for Index Cases:\n\n① Patients hospitalized at a participating medical institution.\n\n* The subject and\u002For their legal guardian agrees to participate in this clinical study, has signed the informed consent form, and is able to comply with the protocol requirements for follow-up and complete all study procedures and assessments.\n\n  * Age ≥ 2 years.\n\n    * Positive for influenza virus as determined by a Rapid Antigen Test (RAT) or Nucleic Acid Amplification Test (NAAT) on a respiratory specimen (e.g., oropharyngeal swab, nasopharyngeal swab, sputum, or bronchoalveolar lavage fluid).\n\n      (2) Inclusion Criteria for Room Contacts:\n\n      ① Patients hospitalized at a participating medical institution.\n* The subject and\u002For their legal guardian agrees to participate in this clinical study, has signed the informed consent form, and is able to comply with the protocol requirements for follow-up and complete all study procedures and assessments.\n\n  ③ Age ≥ 12 years.\n  * Expected to remain hospitalized for ≥ 72 hours.\n\n    * Shares a room with at least one hospitalized index case who has been confirmed with influenza virus infection by RAT or NAAT on a respiratory specimen within the last 120 hours and developed influenza-related symptoms within the last 120 hours, and is expected to share the same room for ≥ 24 hours.\n\n      ⑥ Negative for influenza virus as determined by a Nucleic Acid Amplification Test (NAAT) on a throat swab collected on Day 1.\n\n      3.Exclusion Criteria\n\n      (1) Index Cases There are no exclusion criteria for index cases. (2) Exclusion Criteria for Room Contacts:\n      * Room contacts with a known allergy to the active ingredients or excipients of the investigational drugs.\n* Room contacts who have been diagnosed with or have had an influenza virus infection in the past 12 weeks.\n\n  * Use of any anti-influenza antiviral drugs within 2 weeks prior to screening, including: neuraminidase inhibitors, polymerase inhibitors, hemagglutinin inhibitors, and M2 ion channel blockers (e.g., Oseltamivir, Zanamivir, Peramivir, Favipiravir, Arbidol, Baloxavir Marboxil, Amantadine, or Rimantadine, or other anti-influenza drugs approved by the NMPA).\n\n    * Known to be pregnant or breastfeeding. (Subjects who suspect they may be pregnant must report this to the investigator, who will confirm with a pregnancy test).\n\n      * History of fever (axillary temperature ≥ 37.3°C) within 72 hours prior to screening.\n\n        * Child-Pugh class B or C, or an eGFR ≤ 60 mL·min-¹·(1.73 m²)-¹. ⑦ Any subject deemed unsuitable for participation in the study by the investigator.","ALL","12 Years",{"count":92,"type":93},384,"ESTIMATED","INTERVENTIONAL",[96],"PHASE3","This study aims to evaluate the efficacy of antiviral prophylaxis in preventing in-hospital influenza transmission. We will enroll hospitalized patients with confirmed influenza (index cases) and their uninfected roommates (room contacts). These room contacts will be randomized in a 1:1:1 ratio to one of three prophylactic groups: placebo, suraxavir marboxil, or oseltamivir. The primary outcome will be the rate of influenza infection among the room contacts, which will be monitored to determine the effectiveness of the interventions.",[99],"Influenza",[101,16,102],"influenza","oseltamivir","2026-03-19",{"date":105,"type":106},"2026-03-23","ACTUAL",{"date":108,"type":106},"2025-11-28",{"date":110,"type":93},"2027-03-06",{"name":5,"class":6},2]