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Phase 2Not yet recruiting

Precision Medicine Adaptive Network Platform Trial in Hypoxemic Acute Respiratory Failure (US-PANTHER)

Sponsor
University of Colorado, Denver (Academic or other)
Enrolment
300 planned
Conditions
ARDS (Acute Respiratory Distress Syndrome); Acute Hypoxic Respiratory Failure
Interventions
Simvastatin; Baricitinib
Ages
adults, older adults
Registry
NCT07779642

Full record on ClinicalTrials.gov

From the registry

The goal of this trial is to accelerate the development of pharmacological therapies for critical illness by identifying biological sub phenotypes in patients with acute respiratory distress syndrome (ARDS). The trial will stratify participants by biological markers into different sub phenotypes, then randomized 1:1:1 to active treatment 1, active treatment 2, or usual care. Initial stratification will be into hyperinflammatory and hypoinflammatory sub phenotypes in ARDS based on plasma biomarker profiles. Regular adaptive analyses will enable efficient identification of treatment effects within each sub phenotype, stopping interventions where there is evidence of efficacy or futility, and bringing in new interventions and potentially new sub phenotypes.

Primary outcomes

  • 28 day organ support free days

History

  1. Study completion expected

  2. Primary completion expected

  3. Last registry update

  4. Started

  5. Registered