About this trial
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.
Eligibility criteria
Qualifiers
a known acute clinical insult or new or worsening respiratory dysfunction
receiving respiratory support via invasive mechanical ventilation or non- invasive mechanical ventilation including continuous positive airway pressure, or high flow nasal oxygen greater than or equal to 30L/min
A pandemic associated syndrome
Disqualifiers
More than 48 hours from the diagnosis of AHRF
Patient is known to be pregnant
Liver transaminases >8 times the upper limit of the normal range
Creatine kinase >10 times the upper limit of the normal range
Trial design
Treatments tested in this trial
- Simvastatin
- Baricitinib
Treatment groups
Locations
Sponsors and collaborators
University of Colorado, Denver
Lead sponsor
Vanderbilt University School of Medicine
Collaborator
Emory University
Collaborator
Wake Forest University
Collaborator
New York University
Collaborator
University of California, San Francisco
Collaborator
Montefiore Medical Center
Collaborator
University of Pennsylvania
Collaborator
Intermountain Health Care, Inc.
Collaborator