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Recruiting Phase 2 NCT06513949

Anti-CD14 Treatment With IC14 in Hospitalized ARDS Patients

Trial Parameters

Condition Acute Respiratory Distress Syndrome
Sponsor Implicit Bioscience
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 56
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-08-15
Completion 2027-09
Interventions
AtibuclimabPlacebo

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 the day 4 oxygenation index assessed as a continuous measure.

Eligibility Criteria

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 f

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