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Anti-CD14 Treatment With IC14 in Hospitalized ARDS Patients

RecruitingPhase 2Ages 18 Years - anyAllImplicit Bioscience
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In plain words

What the trial is, and whether it could suit you

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. The primary outcome is the day 4 oxygenation index assessed as a continuous measure.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: Patients may be included in the study only if they meet all the following criteria: 1. Adult patients (18+) on mechanical ventilations with acute respiratory distress syndrome (ARDS) by Berlin Criteria (≤48 hours) 1. P:F ratio \< 300 2. Positive end-expiratory pressure (PEEP) ≥5 cm H2O 3. Bilateral opacities on chest x-ray or chest computerized tomography (CT)-- not fully explained by effusions, lobar/lung collapse, or nodules 4. Respiratory failure not fully explained by cardiac failure or fluid overload 5. Within 1 week of known clinical insult or new or worsening respiratory symptoms 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 2. Patient or Legal authorized representative able to understand and give written informed consent Exclusion Criteria: An individual fulfilling any of the following criteria should be excluded from enrollment in the study: 1. Significant pre-existing organ dysfunction prior to hospitalization 1. Lung: Currently receiving home oxygen therapy as documented in medical record 2. Heart: Pre-existing congestive heart failure defined as an ejection fraction \<20% as documented in the medical record 3. Renal: End-stage renal disease requiring renal replacement therapy or estimated glomerular filtration rate (eGFR) \<30 mL/min. 4. Liver: Severe chronic liver disease defined as Child-Pugh Class C or hepatic transaminases \>5 times upper limit of normal 5. Hematologic: Baseline platelet count \<50,000/mm3 2. Presence of co-existing infection, including, but not limited to: 1. HIV infection not virally suppressed and with pre-hospitalization CD4 counts ≤ 500 cell/mm3 2. Active tuberculosis or a history of inadequately treated tuberculosis 3. Active hepatitis B or hepatitis C viral infection 3. 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 4. Receiving comfort measures only 5. Requiring \>2 vasopressors 6. Pregnant 7. Prisoners 8. History of hypersensitivity or idiosyncratic reaction to IC14 9. Women who are currently breastfeeding 10. Bronchoscopy safety exclusions 1. P:F \<100 on 100% FiO2 2. Mean pulmonary artery pressure \> 55 mmHg 3. Marked cardiovascular instability (Mean arterial pressure \<55 mmHg with vasopressor support) 4. Intracranial pressure ≥20 mmHg 5. Acute ischemic heart disease (unstable angina or ST-elevation myocardial infarction or Type 1 non-ST-elevation myocardial infarction) 6. Supported on extracorporeal membrane oxygenation 7. Endotracheal tube \<6.5 mm
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What it tests

  • Atibuclimab
  • Placebo
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Where

2 sites
Harborview Medical Center
Seattle, United States
University of Washington
Seattle, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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