[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100409190":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":30,"responsibleParty":76,"collaborators":26,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":26,"enrollmentInfo":88,"targetDuration":26,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":26,"overallStatus":97,"whyStopped":98,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Camostat mesylate","EXPERIMENTAL","Camostat mesylate, oral administration 600mg\u002Fday",[13],"Drug: Camostat Mesylate",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo tablets, oral administration",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Camostat Mesylate","Camostat mesylate, oral administration 600mg\u002Fday (2 x 100mg tablets every 8 hours) for 14 days",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Placebo tablets, oral administration 2 tablets every 8 hours for 14 days",[15],[31,42,50,58,66,71],{"facility":32,"status":26,"city":33,"state":26,"zip":26,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":26},"Centre Hospitalier Victor Dupouy","Argenteuil","France","FR",{"type":37,"coordinates":38},"Point",[39,40],2.24744,48.94788,{"lat":40,"lon":39},{"facility":43,"status":26,"city":44,"state":26,"zip":26,"country":34,"countryCode":35,"cosmosGeoPoint":45,"geoPoint":49,"contacts":26},"AP-HP Hôpital Henri Mondor","Créteil",{"type":37,"coordinates":46},[47,48],2.46569,48.79266,{"lat":48,"lon":47},{"facility":51,"status":26,"city":52,"state":26,"zip":26,"country":34,"countryCode":35,"cosmosGeoPoint":53,"geoPoint":57,"contacts":26},"Centre Hospitalier Sud Ile de France - Melun","Melun",{"type":37,"coordinates":54},[55,56],2.65356,48.5457,{"lat":56,"lon":55},{"facility":59,"status":26,"city":60,"state":26,"zip":26,"country":34,"countryCode":35,"cosmosGeoPoint":61,"geoPoint":65,"contacts":26},"AP-HP Hôpital Bichat","Paris",{"type":37,"coordinates":62},[63,64],2.3488,48.85341,{"lat":64,"lon":63},{"facility":67,"status":26,"city":60,"state":26,"zip":26,"country":34,"countryCode":35,"cosmosGeoPoint":68,"geoPoint":70,"contacts":26},"APHP - Saint Louis",{"type":37,"coordinates":69},[63,64],{"lat":64,"lon":63},{"facility":72,"status":26,"city":60,"state":26,"zip":26,"country":34,"countryCode":35,"cosmosGeoPoint":73,"geoPoint":75,"contacts":26},"Centre de Santé Richerand",{"type":37,"coordinates":74},[63,64],{"lat":64,"lon":63},{"type":77,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100409190","phase-3-camovid--evaluation-of-efficacy-and-safety-of-camostat-mesylate-for-the-treatment-of-sars-cov-2-infection---covid-19-in-ambulatory-adult-patients-100409190",false,"NCT04608266","CAMOVID : Evaluation of Efficacy and Safety of Camostat Mesylate for the Treatment of SARS-CoV-2 Infection - COVID-19 in Ambulatory Adult Patients","A Multicenter Randomized Trial to Evaluate the Efficacy and Safety of Camostat Mesylate for the Treatment of SARS-CoV-2 Infection - COVID-19 in Ambulatory Adult Patients (CAMOVID)","CAMOVID","Inclusion Criteria:\n\n* Patients ≥ 18 years old\n* Patients with an increased risk of severe COVID-19 belonging to one or more of the following groups :\n\n  * Age ≥ 50 years\n  * Body Mass Index ≥ 30 kg\u002Fm²\n  * Diabetes\n  * Hypertension\n  * Chronic renal failure (eGFR \\\u003C60 mL\u002Fmin)\n  * Chronic heart disease\n  * Asthma\u002FChronic Obstructive Pumonary Disease\u002FCystic fibrosis\n  * Chronic liver disease\n  * Chronic neurological disease\n  * Solid organ transplant\n  * Bone marrow transplant\n  * Sickle cell anemia\u002F Major thalassemias\n  * Active or currently treated or \\\u003C1 year diagnosed cancer\n  * Active or currently treated or \\\u003C1 year diagnosed malignant blood disease\n  * Immunosuppressive treatment observed for more than 1 month\n* Laboratory confirmed SARS-CoV2 infection with mild COVID-19, fulfilling all the following criteria:\n\n  * Positive SARS-CoV-2 RT-PCR nasal swab samples AND\n  * Clinical symptoms and signs consistent with SARS-CoV2 infection including but not limited to, fever, upper respiratory tract infection signs, digestive signs, muscle pain, anosmia, dysgueusia…(1)\n* Informed consent to participate to the trial\n* Patients must be able and willing to comply with study visits and procedures\n\nExclusion Criteria:\n\n* Initial need for hospitalization for COVID-19 management\n* Pregnancy and breastfeeding\n* Participation to another interventional drug trial\n* Subject protected by law under guardianship or curatorship\n* Absence of health insurance\n* Known hypersensitivity to camostat mesylate\n* Known person sharing the same household already included in the study\n* Participation to another COVID-19 ambulatory interventional study\n* Patients having completed a full SARS-CoV2 vaccine immunization procedure less than 4 weeks prior to COVID-19 diagnosis (last vaccine injection performed less than 4 weeks prior to COVID-19 diagnosis)","ALL","18 Years",{"count":89,"type":90},70,"ACTUAL","INTERVENTIONAL",[93],"PHASE3","The overall objective of the study is to determine the therapeutic effect and tolerance of Camostat mesylate, compared to placebo in adult patients with ambulatory COVID-19 disease, presenting with risk factors of severe COVID-19. Camostat mesylate is a serine protease TMPRSS2 (Transmembrane Serine Protease 2) inhibitor which has been successfully and safely used to treat pancreatitis-associated pain and post-operative reflux oesophagitis in Japan. More recently, it has been shown to inhibit SARS-CoV-2 viral entry and reduce infection of human primary pneumocytes and lung cell lines.\n\nCamostat mesylate or placebo will be administered to consenting adult patients with virologically confirmed COVID-19, not requiring initial hospitalization. All patients will receive standard of care along with randomized treatments. Outcomes of included patients will be compared between the 2 groups.",[96],"Covid19","TERMINATED","Scientific committee decision due SARS-CoV2 pandemic evolution with a decrease in inclusions and widespread distribution of vaccines","2022-01-27",{"date":101,"type":90},"2022-02-10",{"date":103,"type":90},"2020-12-03",{"date":105,"type":90},"2021-12-02",{"name":5,"class":6},6]