[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100397247":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":26,"locations":39,"responsibleParty":69,"collaborators":26,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":26,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":26,"overallStatus":91,"whyStopped":92,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Inmunotek S.L.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Bacmune (MV130)","ACTIVE_COMPARATOR","Subject included in the active group will receive Bacmune. The dose consists on 2 spray puff every 12 hours for 45 days.",[13],"Biological: BACMUNE (MV130)",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Subject included in the placebo group will receive placebo. The dose consists on 2 spray puff every 12 hours for 45 days.",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","BACMUNE (MV130)","BACMUNE (MV130) is a bacterial preparation that contains a mixture of Gram + and Gram - inactivated bacteria at the concentration of 300 FTU \u002F mL (approx. 10\\^9 bacteria \u002F mL)",[9],null,{"type":28,"name":15,"description":29,"armGroupLabels":30,"otherNames":26},"OTHER","Placebo is a solution on sodium chloride at 0.9%",[15],[32,35,37],{"name":33,"affiliation":26,"role":34},"Rosaura Esperanza Benitez Pérez","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":26,"role":34},"Felipe Monrroy López",{"name":38,"affiliation":26,"role":34},"Blanca Nohemí Zamora Mendoza",[40,52,61],{"facility":41,"status":26,"city":42,"state":26,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":26},"Instituto Nacional de Enfermedades Respiratorias (INER)","Mexico City","Ciudad de México","Mexico","MX",{"type":47,"coordinates":48},"Point",[49,50],-99.12766,19.42847,{"lat":50,"lon":49},{"facility":53,"status":26,"city":54,"state":26,"zip":55,"country":44,"countryCode":45,"cosmosGeoPoint":56,"geoPoint":60,"contacts":26},"Hospital General de Pachuca","Pachuca","42070",{"type":47,"coordinates":57},[58,59],-98.73329,20.11697,{"lat":59,"lon":58},{"facility":62,"status":26,"city":63,"state":26,"zip":26,"country":44,"countryCode":45,"cosmosGeoPoint":64,"geoPoint":68,"contacts":26},"Hospital de Ciudad Valles","San Luis Potosí City",{"type":47,"coordinates":65},[66,67],-100.97135,22.15234,{"lat":67,"lon":66},{"type":70,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100397247","phase-3-efficacy-of-bacmune-mv130-in-the-prevention-of-disease-due-to-covid-19-infection-in-healthcare-personnel-100397247",false,"NCT04452643","Efficacy of BACMUNE (MV130) in the Prevention of Disease Due to COVID-19 Infection in Healthcare Personnel","Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial on the Efficacy of BACMUNE (MV130) in the Prevention of Disease Due to SARS-CoV-2 Infection in Healthcare Personnel","Bacmune","Inclusion Criteria:\n\n* Health personnel who are or have been in contact with patients with disease due to SARS-COV-2 infection within the last 14 days before randomization.\n* Negative result for test against COVID-19.\n* Subjects who have given informed consent.\n* Men or women aged between 18 and 65 years, both included.\n* Subjects who have a smartphone where they can load an APP for monitoring the symptoms.\n\nExclusion Criteria:\n\n* Subjects who are participating in another clinical trial.\n* Subjects who are unable to offer cooperation and\u002For have serious psychiatric disorders.\n* Subjects who are allergic to any of the compounds included into MV130.\n* Subjects who present contraindications to any of the components of BACMUNE (MV130).\n* Subjects who are not able to comply with the dosage regimen.\n* Subjects with immunodeficiencies.\n* Subjects with malignancy involving the bone marrow or lymphoid systems.\n* Pregnant or suspected pregnant women and breastfeeding women.\n* Subjects in medical treatment that affects the response of the immune system. It includes corticosteroids (equal to or more than 20 mg for more than 2 weeks), immunosuppressants, biological agents (such as anti TNF-alpha monoclonal antibodies, etc.).\n* Subjects with HIV.\n* Subjects under treatment with metformin.\n* Subjects treated with Sertraline.\n* Subjects treated with statins.","ALL","18 Years","65 Years",{"count":83,"type":84},0,"ACTUAL","INTERVENTIONAL",[87],"PHASE3","The purpose of this trial is to assess the effect of immunotherapy with the bacterial preparation MV130 on the spread and course of SARS-CoV-2 infection in highly exposed subjets, as is the case with healthcare personnel.",[90],"Covid19","WITHDRAWN","Not authorized by Cofepris (Mexico Competent Regulatory Authority)","2020-10-29",{"date":95,"type":84},"2020-11-02",{"date":97,"type":98},"2020-10","ESTIMATED",{"date":100,"type":98},"2021-12",{"name":5,"class":6},3]