IC14 (anti-CD14) treatment for hospitalized patients with ARDS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 2 study testing IC14, a recombinant chimeric anti-CD14 monoclonal antibody, in adults hospitalized with ARDS. Eligible patients are intubated and enrolled early in ARDS, then randomized to receive IV IC14 or placebo and followed for 28 days. The primary endpoint is the day 4 Oxygenation Index, a measure that combines hypoxemia and ventilatory support intensity, and secondary/exploratory endpoints include inflammatory markers, duration of mechanical ventilation, and mortality. PK/PD sampling includes measuring IC14 levels in serum and bronchoalveolar fluid and exploring presepsin as a pathway-specific biomarker.

Why it matters

Who can join: the full rules

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

Where it's running

• Harborview Medical Center
  Seattle, Washington, United States Recruiting
• University of Washington
  Seattle, Washington, United States Recruiting

Study contacts

• Principal investigator: Linzee Mabrey, MD, MsC — Unversity of Washington
• Study coordinator: Linzee Mabrey, MD, MSc
• Email: mflinzee@uw.edu
• Phone: (206) 897-5051

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.