[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100445032":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":44,"responsibleParty":259,"collaborators":25,"id":263,"slug":264,"hasResults":265,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":269,"eligibilityCriteria":270,"healthyVolunteers":265,"sex":271,"minAge":272,"maxAge":25,"enrollmentInfo":273,"targetDuration":25,"studyType":276,"phases":277,"briefSummary":279,"conditions":280,"keywords":282,"overallStatus":47,"whyStopped":25,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":301},{"fullName":5,"class":6},"Università Vita-Salute San Raffaele","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pirfenidone","EXPERIMENTAL","Patients randomized to Pirfernidone Group will receive tables of 267 mg",[13],"Drug: Pirfenidone",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Patients randomized to Placebo Group will receive 5 ml of Water",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","From days 1-7: 801mg\u002Fday; from days 8-14:1602mg\u002Fday, from day 15 to ICU discharge 2403 mg\u002Fday. All drugs will be delivered by a nasogastric tube divided in 3 daily doses.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"All drugs will be delivered by a nasogastric tube divided in 3 daily doses.",[15],[30],{"name":31,"affiliation":5,"role":32},"Giovanni Landoni, Professor","STUDY_CHAIR",[34,40],{"name":35,"role":36,"phone":37,"phoneExt":38,"email":39},"Nora Di Tomasso, MD","CONTACT","+39022643","7722","ditomasso.nora@hsr.it",{"name":41,"role":36,"phone":37,"phoneExt":42,"email":43},"Giacomo Monti, MD","2222","monti.giacomo@hsr.it",[45,61,76,87,100,113,125,135,147,158,171,179,191,204,217,230,243],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"IRCCS San Raffaele Scientific Institute","RECRUITING","Milan","MI","20132","Italy","IT",{"type":54,"coordinates":55},"Point",[56,57],9.18951,45.46427,{"lat":57,"lon":56},[60],{"name":35,"role":36,"phone":37,"phoneExt":38,"email":39},{"facility":62,"status":47,"city":63,"state":64,"zip":65,"country":51,"countryCode":52,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Ospedale Cesare Arrigo","Alessandria","Piedmont","15121",{"type":54,"coordinates":67},[68,69],8.61007,44.90924,{"lat":69,"lon":68},[72,74],{"name":73,"role":36,"phone":25,"phoneExt":25,"email":25},"Giulia Maj, MD",{"name":73,"role":36,"phone":25,"phoneExt":25,"email":75},"giulia.maj@ospedale.al.it",{"facility":77,"status":47,"city":78,"state":25,"zip":25,"country":51,"countryCode":52,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Ospedale Santa Maria","Bari",{"type":54,"coordinates":80},[81,82],16.86982,41.12066,{"lat":82,"lon":81},[85],{"name":86,"role":36,"phone":25,"phoneExt":25,"email":25},"Michele Gerardi",{"facility":88,"status":47,"city":89,"state":25,"zip":90,"country":51,"countryCode":52,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"ASST Spedali Civili di Brescia","Brescia","25123",{"type":54,"coordinates":92},[93,94],10.21472,45.53558,{"lat":94,"lon":93},[97],{"name":98,"role":36,"phone":25,"phoneExt":25,"email":99},"Matteo Filippini, MD","matteo.filippini123@gmail.com",{"facility":101,"status":47,"city":102,"state":25,"zip":103,"country":51,"countryCode":52,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Ospedale San Giovanni di Dio - 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Policlinico Tor Vergata","Rome","00133",{"type":54,"coordinates":196},[197,198],12.51133,41.89193,{"lat":198,"lon":197},[201],{"name":202,"role":36,"phone":25,"phoneExt":25,"email":203},"Valentina Ajello, MD","valeajello@gmail.com",{"facility":205,"status":47,"city":206,"state":25,"zip":207,"country":51,"countryCode":52,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"Azienda Ospedaliero Universitaria Senese","Siena","53100",{"type":54,"coordinates":209},[210,211],11.33064,43.31822,{"lat":211,"lon":210},[214],{"name":215,"role":36,"phone":25,"phoneExt":25,"email":216},"Casere Biuzzi, prof","cesare.biuzzi@ao-siena.toscana.it",{"facility":218,"status":47,"city":219,"state":25,"zip":220,"country":51,"countryCode":52,"cosmosGeoPoint":221,"geoPoint":225,"contacts":226},"AOU Città della Salute e della Scienza","Torino","10126",{"type":54,"coordinates":222},[223,224],11.99138,44.88856,{"lat":224,"lon":223},[227],{"name":228,"role":36,"phone":25,"phoneExt":25,"email":229},"Gabriele Sales, MD","gabriele.sales86@gmail.com",{"facility":231,"status":47,"city":232,"state":25,"zip":233,"country":51,"countryCode":52,"cosmosGeoPoint":234,"geoPoint":238,"contacts":239},"Azienda Sanitaria Universitaria Integrata di Udine","Udine","33100",{"type":54,"coordinates":235},[236,237],13.23715,46.0693,{"lat":237,"lon":236},[240],{"name":241,"role":36,"phone":25,"phoneExt":25,"email":242},"Tiziana Bove, prof","tiziana.bove@asufc.sanita.fvg.it",{"facility":244,"status":47,"city":245,"state":25,"zip":246,"country":247,"countryCode":248,"cosmosGeoPoint":249,"geoPoint":253,"contacts":254},"Astana Medical University","Astana","010000","Kazakhstan","KZ",{"type":54,"coordinates":250},[251,252],71.44598,51.1801,{"lat":252,"lon":251},[255],{"name":256,"role":36,"phone":257,"phoneExt":25,"email":258},"Aidos Konkayev, Full Professor","+77475339215","konkaev@mail.ru",{"type":260,"investigatorFullName":261,"investigatorTitle":262,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Giovanni Landoni","MD, Associate Professor","100445032","phase-3-pirfenidone-to-prevent-fibrosis-in-ards-100445032",false,"NCT05075161","Pirfenidone to Prevent Fibrosis in Ards.","Pirfenidone to Prevent Fibrosis in ARDS. A Randomized Controlled Trial - PIONEER","PIONEER","Inclusion Criteria:\n\nConcomitant presence of:\n\n* ARDS (moderate and severe) - Berlin definition\n\n  1. Within 1 week of a known clinical insult or new or worsening respiratory symptoms\n  2. Bilateral opacities on CXR which are not fully explained by effusions, lobar\u002Flung collapse or nodules\n  3. Respiratory failure not fully explained by cardiac failure or fluid overload\n  4. PaO2\u002FFiO2\\\u003C200 mmHg with PEEP\\\u003C=5 cmH2O (invasive mechanical ventilation)\n* Inflammatory ARDS phenotype (28), defined by at least one of the following:\n\n  1. High plasma levels of inflammatory biomarkers\n  2. Vasopressor dependence\n  3. Lower serum bicarbonate or increased serum lactate\n* Informed consent expressed by the patient or by legal representative or on the Ethical Committee indication.\n* Age \\>=18 years\n\nExclusion Criteria:\n\n* Intubated and mechanically ventilated via an endotracheal or tracheostomy tube (\\>7 days) up to the time of randomization\n* ARDS severe or moderate for more than 36 hours\n* Untreated pulmonary embolism, pleural effusion or pneumothorax as the primary cause of ARF\n* ARF fully explained by left ventricular failure or fluid overload\n* Consent declined\n* Severe chronic respiratory disease requiring domiciliary ventilation\n* Clinical suspicion for significant restrictive lung disease\n* Pregnant women or women of childbearing potential who are sexually active\n* Known allergy to pirfenidone\n* Concomitant use of fluvoxamine\n* Known severe hepatic failure\n* Known severe renal failure or necessity of dialysis not related to acute disease\n* Little chance of survival (SAPS II score\\>75)","ALL","18 Years",{"count":274,"type":275},130,"ESTIMATED","INTERVENTIONAL",[278],"PHASE3","Acute respiratory distress syndrome (ARDS) is a severe form of acute lung injury and a major cause of Intensive Care Unit (ICU) admission worldwide. Despite a large number of randomized clinical trials, a specific and effective pharmacological approach for patients with ARDS is still lacking.\n\nFibroproliferation is a crucial part of the host defence response, and severe fibrotic lung disease affects ARDS patients even years after acute phase resolution.\n\nPirfenidone is an oral anti-fibrotic drug, approved and largely used for treatment of idiopathic pulmonary fibrosis (IPF). The effect of Pirfenidone in ARDS has been evaluated only in animal models.\n\nThis is a randomized controlled study to evaluate for the first time the efficacy of Pirfenidone in ARDS.",[281],"Acute Respiratory Distress Syndrome (ARDS)",[283,284,285,286,287,288,289,290,291],"ARDS","Pulmonary Fibrosis","Mechanical Ventilation","Antifibrotic drug","Intensive Care Unit","ICU discharge","Mortality","Spirometry","Quality of life","2026-05-05",{"date":294,"type":295},"2026-05-08","ACTUAL",{"date":297,"type":295},"2022-06-01",{"date":299,"type":275},"2026-12",{"name":5,"class":6},17]