[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650483":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":31,"locations":37,"responsibleParty":43,"collaborators":30,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":30,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":30,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":70,"whyStopped":30,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":81},{"fullName":5,"class":6},"Shionogi Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Secutrelvir","EXPERIMENTAL","Participants will receive secutrelvir administered orally.",[13],"Drug: Secutrelvir",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants will receive placebo administered orally.",[19],"Drug: Placebo",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Secutrelvir will be administered orally as a tablet.",[9],[26],"S-892216",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Placebo will be administered orally as a tablet.",[15],null,[32],{"name":33,"role":34,"phone":35,"phoneExt":30,"email":36},"Shionogi Clinical Trials Administrator Clinical Support Help Line","CONTACT","1-800-849-9707","Shionogiclintrials-admin@shionogi.co.jp",[38],{"facility":39,"status":30,"city":40,"state":30,"zip":30,"country":41,"countryCode":42,"cosmosGeoPoint":30,"geoPoint":30,"contacts":30},"Japanese Site 1","Multiple Locations","Japan","JP",{"type":44,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100650483","phase-3-study-of-secutrelvir-in-participants-with-covid-19-100650483",false,"NCT07746544","Study of Secutrelvir in Participants With COVID-19","A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Secutrelvir in Participants With COVID-19","Key Inclusion Criteria:\n\n* Must be 12 to \\\u003C 18 years of age (where permitted by local regulation) with a body weight ≥ 40 kilograms (kg), or ≥ 18 and \\\u003C 75 years of age regardless of body weight, at the time of signing the informed consent form (ICF).\n* Must have ≥ 1 of the protocol-defined COVID-19 symptoms of moderate or severe, present within 24 hours prior to randomization.\n* Confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as determined by any SARS-CoV-2 test, collected ≤ 48 hours prior to randomization.\n* Must be randomized within 48 hours of COVID-19 symptom onset, defined as the time when the first COVID-19 symptom occurs.\n* Agrees not to participate in another clinical study for the treatment of COVID-19 until completion of the study.\n\nKey Exclusion Criteria:\n\n* Current need or anticipated need for hospitalization within 24 hours, due to signs of severe COVID-19 illness or due to other medical conditions requiring hospitalization in the opinion of the site investigator.\n* Documented respiratory infection (for example, influenza, respiratory syncytial virus infection) other than COVID 19 within 14 days prior to the screening visit.\n* Known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy).\n* Suspected or confirmed COVID-19 outside of the current episode within 3 months of randomization.\n* Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the investigational intervention.\n* Ongoing long COVID or postacute sequelae of COVID (PASC) diagnosis.\n* Current severely immunocompromised conditions.\n* Received or expected to receive any other COVID-19-specific therapies.\n* Have previously received secutrelvir.\n* Exposed to an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the screening visit.\n\nNote: Other protocol-defined inclusion and exclusion criteria may apply.","ALL","12 Years","74 Years",{"count":56,"type":57},1200,"ESTIMATED","INTERVENTIONAL",[60],"PHASE3","The main purpose of this study is to compare secutrelvir to placebo with respect to resolution of clinical symptoms in nonhospitalized participants with Coronavirus Disease 2019 (COVID-19) starting intervention within 48 hours of COVID-19 symptom onset.",[63],"COVID-19",[26,65,66,67,68,69],"SARS-CoV-2","Mpro","Main Protease","Nonstructural Protein 5","nsp5","NOT_YET_RECRUITING","2026-08-03",{"date":73,"type":74},"2026-08-05","ACTUAL",{"date":76,"type":57},"2026-07-20",{"date":78,"type":57},"2027-08-31",{"name":80,"class":6},"Shionogi",1]