[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100492199":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":38,"responsibleParty":59,"collaborators":25,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":25,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":78,"conditions":79,"keywords":25,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Azvudine","ACTIVE_COMPARATOR","Azvudine in Patients at Potential Risk of Progressing to Severe COVID-19 Infection",[13],"Drug: Azvudine",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo in Patients at Potential Risk of Progressing to Severe COVID-19 Infection",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Azvudine po. 5mg daily for 7 days",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Placebo po. 5 tablets daily for 7 days",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Xinlun Tian","CONTACT","+8613911204657","tianxl@pumch.cn",{"name":36,"role":32,"phone":25,"phoneExt":25,"email":37},"Mengzhao Wang","wangmengzhao@pumch.cn",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital","RECRUITING","Beijing","Beijing Municipality","100730","China","CN",{"type":48,"coordinates":49},"Point",[50,51],116.39723,39.9075,{"lat":51,"lon":50},[54,57],{"name":55,"role":32,"phone":56,"phoneExt":25,"email":34},"Xinlun Tian, Dr.","8601069155154",{"name":36,"role":58,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"type":60,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100492199","phase-2-multicenter-randomized-double-blind-placebo-controlled-study-to-investigate-azvudine-in-symptomatic-adults-with-covid-19-at-increased-risk-of-progressing-to-severe-illness-100492199",false,"NCT05689034","Multicenter Randomized Double-blind Placebo-controlled Study to Investigate Azvudine in Symptomatic Adults With COVID-19 at Increased Risk of Progressing to Severe Illness","A Multicenter Randomized Double-blind Placebo-controlled Study to Investigate Azvudine in Symptomatic Adult Participants With COVID-19 Who Are at Increased Risk of Progressing to Severe Illness","Inclusion Criteria:\n\n* (1) An age of 18 years or over (inclusive); (2) Not more than five days since the development of COVID-19 symptoms, and positive for nucleic acid or antigen test for COVID-19 within five days before enrollment; (3) Presence of at least one symptom related to COVID-19 infection at the time of enrollment; (4) Agreement to practice effective birth control (for females of child-bearing potential); (5) Presence of at least one high risk factor for severe COVID-19 infection:\n\n  * Age ≥ 60 years;\n\n    * BMI\\>25；\n\n      * Fever (body temperature ≥ 38℃) for ≥ 3 days;\n\n        * Current smokers (still being smoking within 30 days before enrollment and have used at least 100 cigarettes up to date);\n\n          * Immunosuppressive diseases, including but not limited to: myelosuppression or organ transplantation or primary immunodeficiency disease; prolonged use of immunosuppressive agents (≥ 20 mg\u002Fd for at least 14 days in the case of prednisone within the last 30 days); biologic therapy (such as infliximab, etc.); use of immunomodulators (including but not limited to methotrexate, azathioprine, etc.); radiotherapy and\u002For chemotherapy for any malignancies within 90 days (for chest radiotherapy, this time interval should be more than 6 months);\n\n            * Chronic lung disease (such as asthma requiring intervention daily, bronchiectasis, COPD, pulmonary hypertension, OSAS, interstitial lung disease, etc.);\n\n              * Hypertension; ⑧ Cardiovascular diseases (previously diagnosed as myocardial infarction or stroke, TIA (transient ischemic attack), cardiac insufficiency, angina pectoris requiring nitrate therapy, CABG, post-PCI, post-carotid endarterectomy and aortic bypass surgery, etc.);\n\n                ⑨ Type 1 or type 2 diabetes;\n\n                ⑩ Neurodevelopmental abnormalities (such as cerebral palsy, Down's syndrome) or other genetic or metabolic syndromes and severe congenital malformations;\n\n                ⑪ Active tumors (excluding localized skin cancer);\n\n                ⑫ No vaccination against COVID-19\n\nExclusion Criteria:\n\n* (1) Known or suspected allergy to the components of Azvudine Tablets; (2) Patients diagnosed as severe or critical COVID-19 infection (Severe: 1. shortness of breath with RR ≥ 30 breaths\u002Fmin; 2. oxygen saturation ≤ 93% when inhaling air at rest; 3. partial pressure of arterial oxygen (PaO2) \u002F fraction of inspired oxygen (FiO2) ≤ 300 mmHg; 4. progressive worsening of clinical symptoms, and obvious lesion progression \\> 50% on lung images within 24 to 48 hours. Critical: 1. respiratory failure, requiring mechanical ventilation; 2. shock; 3. concomitant organ failure, requiring care in ICU); (3) Patients with severe liver disease (total bilirubin \\[TBIL\\] ≥ 2 × upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 3 × ULN; (4) Patients with severe renal insufficiency (glomerular filtration rate ≤ 60 mL\u002Fmin\u002F1.73 m2) or currently on continuous renal replacement therapy, hemodialysis, and\u002For peritoneal dialysis; (5) Patients with malabsorption syndrome or any other condition compromising gastrointestinal absorption, or patients requiring parenteral nutrition or with difficulty in taking the investigational product orally; (6) Known HIV infection; (7) Presence of diabetic ketosis or hyperosmolar hyperglycemic state (HHS); (8) Total neutrophil count \\\u003C 750 cells\u002FL; (9) Pregnant or lactating women or those who plan to have a child during participation in this study and within six months after the end of this study; (10) Currently participating in another clinical trial or currently using another investigational product; (11) Presence of other active infections (must be etiologically confirmed) in addition to COVID-19 infection; (12) Presence of any comorbidities requiring hospitalization and\u002For a surgical procedure within 7 days prior to the start of this study or a comorbidity considered life-threatening within 30 days prior to the start of this study; (13) Patients who have received or are expected to receive convalescent plasma for COVID-19; (14) Previous treatment with anti-viral agents that have been proved to be effective against COVID-19, including but not limited to Nirmatrelvir\u002FRitonavir or Molnupiravir (this criterion does not apply to use of glucocorticoids for reasons other than COVID-19); (15) Other conditions that make it inappropriate for the participant to take part in this trial at the investigator's discretion.","ALL","18 Years","120 Years",{"count":72,"type":73},1096,"ESTIMATED","INTERVENTIONAL",[76,77],"PHASE2","PHASE3","To investigate whether treatment with Azvudine reduces the risk of severe illness or death in patients who are at a potential risk of progressing to severe COVID-19 infection.",[80],"COVID-19 Respiratory Infection","2024-11-21",{"date":83,"type":84},"2024-11-25","ACTUAL",{"date":86,"type":84},"2023-04-19",{"date":88,"type":73},"2025-12-31",{"name":5,"class":6},1]