[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100443922":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":27,"locations":37,"responsibleParty":61,"collaborators":26,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":26,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":85,"whyStopped":26,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Scientific Center for Anti-infectious Drugs, Kazakhstan","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Efesovir","EXPERIMENTAL","The patients of experimental arm take study drug Efesovir twice a day as an antiviral therapy in dose 0.125 ml \u002F kg. Daily dose of Efesovir: 0.250 ml \u002F kg. Duration of treatment is 5 - 10 days, depending on the severity of the disease.",[13],"Drug: Efesovir",{"label":15,"type":16,"description":17,"interventionNames":18},"Remdesivir","ACTIVE_COMPARATOR","The patients are treated with the antiviral drug \"Remdesivir\" in dose 200 mg intravenously on the 1st day, then by 100 mg intravenously daily for 5 - 10 days, depending on the severity of the disease.",[13],[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Antiviral therapy of COVID19 with Efesovir oral solution in dose 0.125 ml \u002F kg two times per day. Duration of treatment is 5 - 10 days, depending on the severity of the disease.",[9,15],[25],"FS-1",null,[28,33],{"name":29,"role":30,"phone":31,"phoneExt":26,"email":32},"Marina Lankina, PhD","CONTACT","+77057064410","m-lankina@list.ru",{"name":34,"role":30,"phone":35,"phoneExt":26,"email":36},"Gulshara Akhmetova, PhD","+77085348842","akhmetovagk@yandex.ru",[38],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":26,"geoPoint":26,"contacts":45},"Semey Medical University","Semey","East Kazakhstan","071407","Kazakhstan","KZ",[46,50,54,57,59],{"name":47,"role":30,"phone":48,"phoneExt":26,"email":49},"Asel Zh Baibusinova, PhD","+7 (702)725-07-96","assel.baibussinova@nao-mus.kz",{"name":51,"role":30,"phone":52,"phoneExt":26,"email":53},"Maukaeva B Saule, PhD","+7(7052)-529-66-75","saule.maukayeva@nao-mus.kz",{"name":55,"role":56,"phone":26,"phoneExt":26,"email":26},"Raikhan E Tuleutaeva, kandidate of medical science","PRINCIPAL_INVESTIGATOR",{"name":47,"role":58,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"name":60,"role":58,"phone":26,"phoneExt":26,"email":26},"Saule B Maukaeva, PhD",{"type":62,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100443922","phase-2-efesovir-fs-1-for-covid-19-phase-2-100443922",false,"NCT05060705","\"Efesovir\" (FS-1) for COVID-19, Phase 2","Randomized Controlled Open Study of Safety and Preliminary Efficiency of the Drug \"Efesovir\" (Oral Solution) for Coronavirus Infection (COVID-19)","Inclusion Criteria:\n\n* polymerase chain reaction (PCR) confirmed coronavirus infection (COVID-19) in hospitalized patients with severe risk factors in age from 18 years to 59 years, of both sexes, irrespective of national or ethnic origin\n* the duration of the COVID-19 disease is no more than 10 days\n* informed concent to participate in clinical trials\n* informed concent to to use reliable contraceptive methods while participating in a clinical trial\n\nExclusion Criteria:\n\n* age less than 18 years old and over 59 years old\n* pregnancy or breastfeeding\n* hypersensitivity, allergy, intolerance to iodine, iodine-containing medicines\n* hypersensitivity to Remdesivir or its components\n* impaired consciousness, causing the impossibility of oral administration\n* conditions or circumstances that, in the opinion of the investigator, may affect the patient's safety or the quality of the results obtained\n* participation in another clinical trial, including in the period up to 2 months before this study\n* signs of multiple organ failure\n* alanine aminotransferase (ALT), aspartate aminotransferase (AST) is 5 or more times higher than normal\n* thrombocytopenia below 100 \\* 10\\^9\u002F l\n* decrease in glomerular filtration rate (GFR) less than 30 ml \u002F min by 1.73 m2\n* chronic heart failure with reduced ejection fraction\n* liver failure\n* coagulopathy\n* mechanical ventilation for 48 hours or more\n* extracorporeal membrane oxygenation (ECMO)\n* disseminated intravascular coagulation","ALL","18 Years","59 Years",{"count":74,"type":75},62,"ESTIMATED","INTERVENTIONAL",[78],"PHASE2","Study of the efficacy and safety of the new drug \"Efesovir\" in comparison with the drug \"Remdesivir\" in the treatment of patients hospitalized with COVID-19.\n\nThe hypothesis of clinical study is the clinical efficacy of new drug \"Efesovir\" is 10% to 30% higher than of \"Remdesivir\".",[81],"Covid19",[83,84,25,9],"COVID19","viral pneumonia","NOT_YET_RECRUITING","2024-04-16",{"date":88,"type":89},"2024-04-17","ACTUAL",{"date":91,"type":75},"2025-12",{"date":93,"type":75},"2026-11",{"name":5,"class":6},1]