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NCT06513949
Anti-CD14 Treatment With IC14 in Hospitalized ARDS Patients
Conditions: Acute Respiratory Distress Syndrome, Adult Respiratory Distress Syndrome, Acute Lung Injury, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 56
Sponsor: Implicit Bioscience
Location: Harborview Medical Center Seattle Washington
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 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 \
Source: ClinicalTrials.gov (NCT06513949). StuddyBuddy aggregates publicly available trial information.