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Recruiting Phase 2

Anti-CD14 Treatment With IC14 in Hospitalized ARDS Patients

NCT06513949 · tracked via the Priya Life Science USA tracker
Phase
Phase 2
Started
2026-06-17
Last updated
2026-07-29

Condition(s) studied

Acute Respiratory Distress SyndromeAdult Respiratory Distress SyndromeAcute Lung InjuryAcute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)

Investigational drug(s) / intervention(s)

Atibuclimab →Placebo

Atibuclimab: monoclonal antibody against human CD14

Placebo: Sterile normal saline for injection

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Day 4 Oxygenation Index — Day 1 through Day 4
    (mean airway pressure x fraction of inspired oxygen \[FiO2\] x100)/ partial pressure of oxygen \[PaO2\]

Trial sites (2)

FacilityCityRegionStatus
Harborview Medical Center Seattle Washington Recruiting
University of Washington Seattle Washington Recruiting

More Implicit Bioscience trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06513949 on ClinicalTrials.gov ↗ ← All trials in the USA