NCT07675265Recruiting
Observational, Non-interventional Biomarker and Endotyping Study
Prenosis, Inc.
Start Date
9/14/2026
Completion Date
3/1/2029
Summary
The goal of this observational study is to establish a centralized ARDS biorepository of longitudinal biospecimens and harmonized clinical data, develop unsupervised, therapy-agnostic endotyping algorithms, and develop unsupervised, therapy-specific treatment-prediction algorithms over a 24 month period.
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
* Age ≥18 years
* ARDS Diagnosis (New Global Definition of ARDS)
* Timing: Acute onset within 7 days
* Radiology: Bilateral pulmonary opacities
* Hypoxia:
Non-intubated ARDS: PaO2:FIO2\<300mmHg or SpO2:FIO2\<315 (if SpO2\<97%) on HFNO with flow of \>30 L/min or NIV/CPAP with at least 5 cm H2O end-expiratory pressure; or Intubated ARDS: PaO2:FIO2\<300 mm Hg or SpO2:FIO2\<315 (if SpO2\<97%)
* ICU admission
* Enrolled within 72 hours of meeting inclusion criteria
Exclusion Criteria:
• Primary cardiogenic pulmonary edema
Conditions
ARDS (Acute Respiratory Distress Syndrome)
Locations
Carle Foundation Hospital
Urbana, Illinois 61801
United States