Actively Recruiting
Anti-CD14 Treatment With IC14 in Hospitalized ARDS Patients
Led by Implicit Bioscience · Updated on 2025-08-20
56
Participants Needed
2
Research Sites
119 weeks
Total Duration
On this page
Sponsors
I
Implicit Bioscience
Lead Sponsor
U
University of Washington
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Anti-CD14 Treatment With IC14 in Hospitalized ARDS Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- On mechanical ventilation with ARDS diagnosed by Berlin Criteria within 48 hours
- P:F ratio less than 300
- Positive end-expiratory pressure (PEEP) of 5 cm H2O or higher
- Bilateral lung opacities on chest x-ray or CT scan not fully explained by other causes
- Respiratory failure not fully explained by heart failure or fluid overload
- Symptoms or clinical insult within 1 week
- Patient or legal representative able to give written informed consent
You will not qualify if you...
- Significant pre-existing organ dysfunction prior to hospitalization including:
- Lung: Receiving home oxygen therapy
- Heart: Congestive heart failure with ejection fraction less than 20%
- Kidney: End-stage renal disease requiring dialysis or eGFR less than 30 mL/min
- Liver: Severe chronic liver disease (Child-Pugh Class C) or very high liver enzymes
- Hematologic: Platelet count less than 50,000/mm3
- Co-existing infections including:
- HIV not virally suppressed with CD4 counts 500 or less
- Active or inadequately treated tuberculosis
- Active hepatitis B or C infection
- Treatment within 30 days or five half-lives with certain immunosuppressants or immunomodulators
- Receiving comfort measures only
- Requiring more than two vasopressors
- Pregnant
- Prisoners
- History of hypersensitivity or reaction to IC14
- Currently breastfeeding
- Bronchoscopy safety exclusions including:
- P:F ratio less than 100 on 100% oxygen
- Mean pulmonary artery pressure over 55 mmHg
- Severe cardiovascular instability
- Intracranial pressure 20 mmHg or higher
- Acute ischemic heart disease
- Supported on extracorporeal membrane oxygenation
- Endotracheal tube smaller than 6.5 mm
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Harborview Medical Center
Seattle, Washington, United States, 98104
Actively Recruiting
2
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
L
Linzee Mabrey, MD, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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