Precision Medicine Adaptive Network Platform Trial in Hypoxemic Acute Respiratory Failure

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.

Conditions

• ARDS (Acute Respiratory Distress Syndrome)
• Acute Hypoxic Respiratory Failure

Interventions

DRUG

Simvastatin

Simvastatin will be administered at a dose of 80 mg once daily by the enteral route for up to 28 days

DRUG

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

Sponsors & Collaborators

• Vanderbilt University School of Medicine

  collaborator OTHER

• Emory University

  collaborator OTHER

• Wake Forest University

  collaborator OTHER

• New York University

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• Montefiore Medical Center

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• Intermountain Health Care, Inc.

  collaborator OTHER

• University of Colorado, Denver

  lead OTHER

Principal Investigators

• Neil Aggarwal, MD · University of Colorado, Denver

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-30

Primary Completion

2029-09-30

Completion

2030-09-30

FDA Drug

Yes