[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555581":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":45,"responsibleParty":75,"collaborators":77,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":33,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":33,"enrollmentInfo":88,"targetDuration":33,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":100,"overallStatus":48,"whyStopped":33,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Implicit Bioscience","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"IC14 (atibuclimab)","EXPERIMENTAL","IC14 (atibuclimab) is a recombinant monoclonal antibody against human CD14",[13],"Biological: Atibuclimab",{"label":15,"type":16,"description":17,"interventionNames":18},"Identical-appearing placebo","PLACEBO_COMPARATOR","Sterile normal saline",[19],"Other: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","Atibuclimab","monoclonal antibody against human CD14",[9],[27],"IC14",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"OTHER","Placebo","Sterile normal saline for injection",[15],null,[35],{"name":36,"affiliation":37,"role":38},"Linzee Mabrey, MD, MsC","Unversity of Washington","PRINCIPAL_INVESTIGATOR",[40],{"name":41,"role":42,"phone":43,"phoneExt":33,"email":44},"Linzee Mabrey, MD, MSc","CONTACT","(206) 897-5051","mflinzee@uw.edu",[46,64],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Harborview Medical Center","RECRUITING","Seattle","Washington","98104","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-122.33207,47.60621,{"lat":58,"lon":57},[61,63],{"name":62,"role":42,"phone":33,"phoneExt":33,"email":33},"Linzee Mabrey, MD",{"name":62,"role":38,"phone":33,"phoneExt":33,"email":33},{"facility":65,"status":48,"city":49,"state":50,"zip":66,"country":52,"countryCode":53,"cosmosGeoPoint":67,"geoPoint":69,"contacts":70},"University of Washington","98195",{"type":55,"coordinates":68},[57,58],{"lat":58,"lon":57},[71,73],{"name":41,"role":42,"phone":72,"phoneExt":33,"email":44},"206-731-4165",{"name":74,"role":38,"phone":33,"phoneExt":33,"email":33},"Eric Morrell, MD, PhD",{"type":76,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[78],{"name":65,"class":29},"100555581","phase-2-anti-cd14-treatment-with-ic14-in-hospitalized-ards-patients-100555581",false,"NCT06513949","Anti-CD14 Treatment With IC14 in Hospitalized ARDS Patients","Phase 2, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Anti-CD14 Treatment With a Recombinant Chimeric Monoclonal Antibody (IC14) in Hospitalized Patients With Acute Respiratory Distress Syndrome","Inclusion Criteria:\n\nPatients may be included in the study only if they meet all the following criteria:\n\n1. Adult patients (18+) on mechanical ventilations with acute respiratory distress syndrome (ARDS) by Berlin Criteria (≤48 hours)\n\n   1. P:F ratio \\\u003C 300\n   2. Positive end-expiratory pressure (PEEP) ≥5 cm H2O\n   3. Bilateral opacities on chest x-ray or chest computerized tomography (CT)-- not fully explained by effusions, lobar\u002Flung collapse, or nodules\n   4. Respiratory failure not fully explained by cardiac failure or fluid overload\n   5. Within 1 week of known clinical insult or new or worsening respiratory symptoms\n\n   i. Common Risk Factors for ARDS: Pneumonia, aspiration, inhalation injury, pulmonary contusion, pulmonary vasculitis, drowning, non-pulmonary sepsis, major trauma, pancreatitis, severe burns, non-cardiogenic shock, drug overdose, multiple transfusions\n2. Patient or Legal authorized representative able to understand and give written informed consent\n\nExclusion Criteria:\n\nAn individual fulfilling any of the following criteria should be excluded from enrollment in the study:\n\n1. Significant pre-existing organ dysfunction prior to hospitalization\n\n   1. Lung: Currently receiving home oxygen therapy as documented in medical record\n   2. Heart: Pre-existing congestive heart failure defined as an ejection fraction \\\u003C20% as documented in the medical record\n   3. Renal: End-stage renal disease requiring renal replacement therapy or estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin.\n   4. Liver: Severe chronic liver disease defined as Child-Pugh Class C or hepatic transaminases \\>5 times upper limit of normal\n   5. Hematologic: Baseline platelet count \\\u003C50,000\u002Fmm3\n2. Presence of co-existing infection, including, but not limited to:\n\n   1. HIV infection not virally suppressed and with pre-hospitalization CD4 counts ≤ 500 cell\u002Fmm3\n   2. Active tuberculosis or a history of inadequately treated tuberculosis\n   3. Active hepatitis B or hepatitis C viral infection\n3. Current treatment, or treatment within 30 days or five half-lives (whichever is longer) with etanercept (Enbrel®), infliximab (Remicade®), adalimumab (Humira®), certolizumab (Cimzia®), golimumab (Simponi®), anakinra (Kineret®), rilonacept (Arcalyst®), tocilizumab (Actemra®), sarilumab (Kevzara®), siltuximab (Sylvant®), or other potent immunosuppressant or immunomodulatory drugs or treatments\n4. Receiving comfort measures only\n5. Requiring \\>2 vasopressors\n6. Pregnant\n7. Prisoners\n8. History of hypersensitivity or idiosyncratic reaction to IC14\n9. Women who are currently breastfeeding\n10. Bronchoscopy safety exclusions\n\n    1. P:F \\\u003C100 on 100% FiO2\n    2. Mean pulmonary artery pressure \\> 55 mmHg\n    3. Marked cardiovascular instability (Mean arterial pressure \\\u003C55 mmHg with vasopressor support)\n    4. Intracranial pressure ≥20 mmHg\n    5. Acute ischemic heart disease (unstable angina or ST-elevation myocardial infarction or Type 1 non-ST-elevation myocardial infarction)\n    6. Supported on extracorporeal membrane oxygenation\n    7. Endotracheal tube \\\u003C6.5 mm","ALL","18 Years",{"count":89,"type":90},56,"ESTIMATED","INTERVENTIONAL",[93],"PHASE2","Hospitalized patients with ARDS will be randomized to intravenous treatment with a monoclonal antibody against CD14, called IC14, or placebo. They will be followed for 28 days.\n\nThe primary outcome is the day 4 oxygenation index assessed as a continuous measure.",[96,97,98,99],"Acute Respiratory Distress Syndrome","Adult Respiratory Distress Syndrome","Acute Lung Injury","Acute Lung Injury\u002FAcute Respiratory Distress Syndrome (ARDS)",[101,27],"ARDS","2025-08-15",{"date":104,"type":105},"2025-08-20","ACTUAL",{"date":102,"type":105},{"date":108,"type":90},"2027-12",{"name":5,"class":6},2]