Observational, Non-interventional Biomarker and Endotyping 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.

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Key information

Conditions

ARDS (Acute Respiratory Distress Syndrome) Acute Lung Injury Lung Diseases Lung Injury Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Number of Participants with an ARDS Diagnosis

Time frame: from enrollment to 28-day in-hospital mortality

Adults with clinically defined ARDS receiving ICU-level care

Sponsors and collaborators

Lead sponsor

Prenosis, Inc.

Industry

Collaborators

Biomedical Advanced Research and Development Authority

Registry information

Official study title

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

Acronym: OBSERVE-ARDS

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2029
First posted: Jun 30, 2026
Registry last updated: Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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