Actively Recruiting
Phase 2, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of IC14 in Hospitalized Patients With Acute Respiratory Distress Syndrome
Led by Implicit Bioscience · Updated on 2025-08-20
56
Participants Needed
2
Research Sites
13 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
Researchers are studying the effects of a monoclonal antibody called IC14 on hospitalized patients with Acute Respiratory Distress Syndrome (ARDS). This phase 2, randomized, double-blind, placebo-controlled trial aims to assess the safety and efficacy of IC14 in reducing lung injury severity, measured primarily by the oxygenation index on day 4. The study also investigates how blocking CD14 affects inflammation and other clinical outcomes in ARDS patients. Participants will be randomly assigned to receive either IC14, a recombinant chimeric monoclonal antibody targeting CD14, or a placebo consisting of sterile normal saline. Treatments are given intravenously while patients remain hospitalized. The study includes safety monitoring and explores additional effects such as mechanical ventilation duration and mortality. Pharmacokinetic and pharmacodynamic assessments involve measuring IC14 levels in lung fluid and blood, as well as blood presepsin levels as a biomarker. During the 28-day follow-up, researchers will evaluate lung function using oxygenation indices and assess inflammation through biomarkers in bronchoalveolar lavage fluid and plasma. They will also monitor organ failure scores, adverse events, and serious events throughout the study period. Participants undergo regular clinical assessments and laboratory tests to track treatment effects and safety. The trial begins with a screening visit and continues with scheduled evaluations up to day 28 post-treatment.
CONDITIONS
Brief Title
Anti-CD14 Treatment With IC14 in Hospitalized ARDS Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or older
- Hospitalized and on mechanical ventilation with acute respiratory distress syndrome (ARDS) by Berlin Criteria within 48 hours
- P:F ratio less than 300
- Positive end-expiratory pressure (PEEP) of 5 cm H2O or higher
- Bilateral opacities on chest x-ray or chest CT not fully explained by other lung conditions
- Respiratory failure not fully explained by heart failure or fluid overload
- Within 1 week of known clinical insult or new or worsening respiratory symptoms
- Patient or legal authorized representative able to understand and provide 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 below 50,000/mm3
- Active infections such as unsuppressed HIV, active or inadequately treated tuberculosis, or active hepatitis B or C
- Treatment within 30 days with certain immunosuppressive or immunomodulatory drugs including etanercept, infliximab, adalimumab, anakinra, tocilizumab, and others
- Receiving comfort measures only
- Requiring more than 2 vasopressors
- Pregnant or breastfeeding women
- Prisoners
- History of allergic or unusual reaction to IC14
- Bronchoscopy safety exclusions including severe hypoxemia, high pulmonary artery pressure, cardiovascular instability, high intracranial pressure, recent acute ischemic heart disease, extracorporeal membrane oxygenation support, or small endotracheal tube size
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 14 days
Participants receive anti-CD14 treatment with IC14 or placebo while hospitalized with ARDS.
Multiple visits during hospitalization from Day 1 through Day 14
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
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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