Observational, Non-interventional Biomarker and Endotyping Study

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07675265

Acronym

OBSERVE-ARDS

Enrollment

1200

Registered

2026-06-30

Start date

2026-07-01

Completion date

2029-03-01

Last updated

2026-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS (Acute Respiratory Distress Syndrome)

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants with an ARDS Diagnosis	from enrollment to 28-day in-hospital mortality	Adults with clinically defined ARDS receiving ICU-level care

Outcome results