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.
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
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.
Parallel
Atibuclimab
Biological/Vaccinemonoclonal antibody against human CD14
Placebo
Other interventionSterile normal saline for injection
Day 4 Oxygenation Index
(mean airway pressure x fraction of inspired oxygen \[FiO2\] x100)/ partial pressure of oxygen \[PaO2\]
Biomarkers of injury and inflammation measured in bronchoalveolar lavage fluid
Interleukin(IL)-6
Biomarkers of injury and inflammation measured in plasma
Interleukin(IL)-6
Oxygenation index
(mean airway pressure x FiO2 x100)/PaO2
Oxygen saturation index
(mean airway pressure x FiO2 x100)/peripheral oxygen saturation \[SpO2\]
Ventilator-free Days
Days alive and free of invasive mechanical ventilation
Mortality
All-cause mortality
Click on the lead sponsor to view all of their trials.
Implicit Bioscience
Lead sponsor
University of Washington
Collaborator
