IC14Anti-CD14 Treatment With IC14 in Hospitalized ARDS Patients

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