[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642133":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":169,"collaborators":30,"id":171,"slug":172,"hasResults":173,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":30,"eligibilityCriteria":177,"healthyVolunteers":173,"sex":178,"minAge":179,"maxAge":180,"enrollmentInfo":181,"targetDuration":30,"studyType":184,"phases":185,"briefSummary":188,"conditions":189,"keywords":191,"overallStatus":43,"whyStopped":30,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":206},{"fullName":5,"class":6},"Shanghai Ark Biopharmaceutical Co., Ltd.","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Active drug(200mg)","EXPERIMENTAL","The participants will receive 200 mg AK0529 twice daily for 5 days from D1 to D5.",[13],"Drug: Ziresovir (AK0529)",{"label":15,"type":10,"description":16,"interventionNames":17},"Active drug(300mg)","The participants will receive 300 mg AK0529 twice daily for 5 days from D1 to D5.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Placebo","PLACEBO_COMPARATOR","The participants will receive placebo of 200 mg, or 300 mg twice daily for 5 days from D1 to D5.",[23],"Drug: Placebo",[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Ziresovir (AK0529)","Active Substance: AK0529 Pharmaceutical Form: Enteric Capsules Route of Administration: Oral",[9,15],null,{"type":26,"name":19,"description":32,"armGroupLabels":33,"otherNames":30},"Active Substance: Placebo Pharmaceutical Form: Enteric Capsules Route of Administration: Oral",[19],[35],{"name":36,"role":37,"phone":38,"phoneExt":30,"email":39},"Chao Yu, Mater","CONTACT","+86 021-50681677","chao.yu@arkbiosciences.com",[41,59,74,88,102,115,129,143,156],{"facility":42,"status":43,"city":44,"state":45,"zip":30,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"China-Japan Friendship Hospital","RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":49,"coordinates":50},"Point",[51,52],116.39723,39.9075,{"lat":52,"lon":51},[55],{"name":56,"role":37,"phone":57,"phoneExt":30,"email":58},"Bin Cao, Professor","+86-010-84205566","caobin_ben@163.com",{"facility":60,"status":61,"city":62,"state":63,"zip":30,"country":46,"countryCode":47,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Guangzhou Medical University Panyu Central Hospital","NOT_YET_RECRUITING","Guangzhou","Guangdong",{"type":49,"coordinates":65},[66,67],113.25,23.11667,{"lat":67,"lon":66},[70],{"name":71,"role":37,"phone":72,"phoneExt":30,"email":73},"Yafei Qi","+86 020-34858888","a6598825@163.com",{"facility":75,"status":43,"city":76,"state":77,"zip":30,"country":46,"countryCode":47,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Cangzhou Hospital of Integrated TCM-WM","Cangzhou","Hebei",{"type":49,"coordinates":79},[80,81],116.85334,38.31124,{"lat":81,"lon":80},[84],{"name":85,"role":37,"phone":86,"phoneExt":30,"email":87},"Li Zhang，Professor","+86 0317-2179231","Zhangli19810210@hotmail.com",{"facility":89,"status":43,"city":90,"state":91,"zip":30,"country":46,"countryCode":47,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"The First Affiliated Hospital of Nanyang Medical College","Nanyang","Henan",{"type":49,"coordinates":93},[94,95],112.54659,33.00524,{"lat":95,"lon":94},[98],{"name":99,"role":37,"phone":100,"phoneExt":30,"email":101},"Yu Zhang，Professor","+86 0377-63328777","zhangyu9896@126.com",{"facility":103,"status":61,"city":104,"state":91,"zip":30,"country":46,"countryCode":47,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Henan Infectious Disease Hospital (The Sixth People's Hospital of Zhengzhou)","Zhengzhou",{"type":49,"coordinates":106},[107,108],113.64861,34.75778,{"lat":108,"lon":107},[111],{"name":112,"role":37,"phone":113,"phoneExt":30,"email":114},"Sanjing Li, Professor","+86 0371-60331627","zzlygrsk@163.com",{"facility":116,"status":43,"city":117,"state":118,"zip":30,"country":46,"countryCode":47,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Wuhan Sixth Hospital","Wuhan","Hubei",{"type":49,"coordinates":120},[121,122],114.26667,30.58333,{"lat":122,"lon":121},[125],{"name":126,"role":37,"phone":127,"phoneExt":30,"email":128},"Fajiu Li，Professor","+86 027-82424252","80670519@qq.com",{"facility":130,"status":61,"city":131,"state":132,"zip":30,"country":46,"countryCode":47,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Zhejiang Hospital","Hangzhou","Zhejiang",{"type":49,"coordinates":134},[135,136],120.16142,30.29365,{"lat":136,"lon":135},[139],{"name":140,"role":37,"phone":141,"phoneExt":30,"email":142},"Hong Wang, Professor","+86 0571-87987373","hong.wang11@163.com",{"facility":144,"status":43,"city":145,"state":132,"zip":30,"country":46,"countryCode":47,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"People's Hospital of Rui'an City","Rui’an",{"type":49,"coordinates":147},[148,149],120.65859,27.77605,{"lat":149,"lon":148},[152],{"name":153,"role":37,"phone":154,"phoneExt":30,"email":155},"Liang Hong，Professor","+86 0577-5623293","rahoshongliang@163.com",{"facility":157,"status":43,"city":158,"state":132,"zip":30,"country":46,"countryCode":47,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Taizhou Hospital of Zhejiang Province","Taizhou",{"type":49,"coordinates":160},[161,162],121.43312,28.66266,{"lat":162,"lon":161},[165],{"name":166,"role":37,"phone":167,"phoneExt":30,"email":168},"Youzu Xu, Professor","+86-0576-85120120","xuyouzu@sina.com",{"type":170,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100642133","phase-2-a-study-of-ziresovir-ak0529-in-high-risk-adult-with-respiratory-syncytial-virus-rsv-infection-100642133",false,"NCT07658534","A Study of Ziresovir (AK0529) in High-risk Adult With Respiratory Syncytial Virus (RSV) Infection.","A Randomized, Double-blind, Two-stage, Placebo-controlled Phase 2b\u002F3 Clinical Study to Evaluate the Efficacy and Safety of Ziresovir (AK0529) in Adult Patients at High Risk for Respiratory Syncytial Virus (RSV) Infection.","Inclusion Criteria:\n\n* Aged 18-85 years (inclusive), regardless of gender.\n* Diagnosed with RSV infection by antigen or nucleic acid test within 36 hours before first dose.\n* Have at least one of the following high-risk conditions for RSV infection: Chronic respiratory disease; heart disease; immunocompromised status; other chronic disease; age ≥65 years.\n* Presence of at least one new LRTD symptom or worsening of a pre-existing LRTD symptom (specifically: cough, expectoration, wheezing, shortness of breath), with at least one individual symptom rated as moderate or severe (score 2 or 3 per RiiQ Symptom Scale).\n* Time from symptom onset (or worsening of pre-existing symptoms) to first dose ≤5 days. (Onset defined as time of first RSV-related symptom\u002Fsign confirmed by investigator; pre-existing symptoms are those due to underlying conditions)\n\nExclusion Criteria:\n\n* Diagnosed with influenza or COVID-19 infection within 7 days prior to providing informed consent.\n* Suspected bacterial co-infection.\n* Received any potentially anti-RSV agents (e.g., ribavirin, long-acting interferon) within 5 half-lives prior to the first study dose, or plans to use such agents during the study.\n* Received prohibited medications, or plans to use prohibited medications during the study.\n* Has a severe or unstable gastrointestinal, hepatic, renal, hematologic disorder, or malignancy.\n* Has a known allergy, hypersensitivity, or intolerance to AK0529 or to any excipients in the AK0529 or placebo formulation.\n* Female participants with a positive pregnancy test result, or who are breastfeeding.\n* Refusal to use effective contraception during the trial period.","ALL","18 Years","85 Years",{"count":182,"type":183},290,"ESTIMATED","INTERVENTIONAL",[186,187],"PHASE2","PHASE3","Respiratory syncytial virus (RSV) is recognized worldwide as a significant pathogen causing lower respiratory tract infection in infants, the elderly, and immunocompromised patients, which may cause bronchiolitis or pneumonia, and affect the cardiovascular system, central nervous system and the renal system, resulting in hospitalization and death risks in children and also high-risk adults, particularly the elderly. The purpose of this study is to evaluate the efficacy of Ziresovir (AK0529) compared to placebo with respect to the time to resolution of RSV lower respiratory tract disease (LRTD) symptoms.",[190],"Respiratory Syncytial Virus Infections",[192,193,194,195,196],"Ziresovir","RSV","Chronic Respiratory Disease","Heart Disease","The Elderly","2026-06-15",{"date":199,"type":200},"2026-06-22","ACTUAL",{"date":202,"type":200},"2026-03-03",{"date":204,"type":183},"2029-01",{"name":5,"class":6},9]