Anti-CD14 Treatment With IC14 in Hospitalized ARDS Patients

Eligibility 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
• 2. Patient or Legal authorized representative able to understand and give written informed consent
• 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