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Precision Medicine Adaptive Network Platform Trial in Hypoxemic Acute Respiratory Failure
Sponsor: University of Colorado, Denver
Summary
The goal of this trial is to accelerate the development of pharmacological therapies for critical illness by identifying biological subphenotypes in patients with acute respiratory distress syndrome (ARDS). The trial will stratify participants by biological markers into different subphenotypes, then randomized 1:1:1 to active treatment 1, active treatment 2, or usual care. Initial stratification will be into hyperinflammatory and hypoinflammatory subphenotypes in ARDS based on plasma biomarker profiles. Regular adaptive analyses will enable efficient identification of treatment effects within each subphenotype, stopping interventions where there is evidence of efficacy or futility, and bringing in new interventions and potentially new subphenotypes.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2026-09
Completion Date
2030-09
Last Updated
2026-08-21
Healthy Volunteers
No
Interventions
Simvastatin
Simvastatin will be administered at a dose of 80 mg once daily by the enteral route for up to 28 days
Baricitinib
Baricitinib will be administered at a dose of 4 mg once daily by the enteral route for up to 10 days.Baricitinib will be prescribed on the participants' in-patient drug administration chart (or equivalent) and administered to the participant by appropriately trained clinical staff with appropriate competencies in accordance with local practice. These staff do not need to be on the study delegation log. The dosing regimen below will be used in the setting of renal impairment: eGFR 30 to \<60 mL/min Baricitinib Dose: 2mg eGFR15 to \<30 mL/min Baricitinib Dose:1mg eGFR \<15 mL/min (or receiving RRT) Baricitinib Dose withheld