Status:
RECRUITING
Anti-CD14 Treatment With IC14 in Hospitalized ARDS Patients
Lead Sponsor:
Implicit Bioscience
Collaborating Sponsors:
University of Washington
Conditions:
Acute Respiratory Distress Syndrome
Adult Respiratory Distress Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
This is a phase 2, randomized, double-blind, placebo-controlled, safety and efficacy study of anti-CD14 treatment with a recombinant chimeric monoclonal antibody (IC14) in hospitalized patients with A...
Eligibility Criteria
Inclusion
- Patients may be included in the study only if they meet all the following criteria:
- Adult patients (18+) on mechanical ventilations with acute respiratory distress syndrome (ARDS) by Berlin Criteria (≤48 hours)
- P:F ratio \< 300
- Positive end-expiratory pressure (PEEP) ≥5 cm H2O
- Bilateral opacities on chest x-ray or chest computerized tomography (CT)-- not fully explained by effusions, lobar/lung collapse, or nodules
- Respiratory failure not fully explained by cardiac failure or fluid overload
- 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
- Patient or Legal authorized representative able to understand and give written informed consent
Exclusion
- An individual fulfilling any of the following criteria should be excluded from enrollment in the study:
- Significant pre-existing organ dysfunction prior to hospitalization
- Lung: Currently receiving home oxygen therapy as documented in medical record
- Heart: Pre-existing congestive heart failure defined as an ejection fraction \<20% as documented in the medical record
- Renal: End-stage renal disease requiring renal replacement therapy or estimated glomerular filtration rate (eGFR) \<30 mL/min.
- Liver: Severe chronic liver disease defined as Child-Pugh Class C or hepatic transaminases \>5 times upper limit of normal
- Hematologic: Baseline platelet count \<50,000/mm3
- Presence of co-existing infection, including, but not limited to:
- HIV infection not virally suppressed and with pre-hospitalization CD4 counts ≤ 500 cell/mm3
- Active tuberculosis or a history of inadequately treated tuberculosis
- Active hepatitis B or hepatitis C viral infection
- 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
- Receiving comfort measures only
- Requiring \>2 vasopressors
- Pregnant
- Prisoners
- History of hypersensitivity or idiosyncratic reaction to IC14
- Women who are currently breastfeeding
- Bronchoscopy safety exclusions
- P:F \<100 on 100% FiO2
- Mean pulmonary artery pressure \> 55 mmHg
- Marked cardiovascular instability (Mean arterial pressure \<55 mmHg with vasopressor support)
- Intracranial pressure ≥20 mmHg
- Acute ischemic heart disease (unstable angina or ST-elevation myocardial infarction or Type 1 non-ST-elevation myocardial infarction)
- Supported on extracorporeal membrane oxygenation
- Endotracheal tube \<6.5 mm
Key Trial Info
Start Date :
August 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT06513949
Start Date
August 15 2025
End Date
December 1 2027
Last Update
August 20 2025
Active Locations (2)
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1
Harborview Medical Center
Seattle, Washington, United States, 98104
2
University of Washington
Seattle, Washington, United States, 98195