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Observational, Non-interventional Biomarker and Endotyping Study

Observational Biomarker Study for the Evaluation of Response and Validation of Endotypes in Acute Respiratory Distress Syndrome

Who can join

Ages 18 and older · All sexes

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

About the study

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.

Sponsor: Prenosis, Inc. · Participants: 1,200 · Started: Sep 14, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07675265

Locations in the U.S.

Conditions

• Acute Lung Injury

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.