Precision Medicine Adaptive Network Platform Trial in Hypoxemic Acute Respiratory Failure

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Colorado, Denver

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

300 Participants
are divided into 3 treatment groups

Locations

This trial has no 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