Observational, Non-interventional Biomarker and Endotyping Study (OBSERVE-ARDS)

June 23, 2026 updated by: Prenosis, Inc.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults with clinically defined acute respiratory distress syndrome (ARDS)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from enrollment to 28-day in-hospital mortality

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prenosis, Inc.

Collaborators

Biomedical Advanced Research and Development Authority

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

June 23, 2026

First Submitted That Met QC Criteria

June 23, 2026

First Posted (Actual)

June 30, 2026

Study Record Updates

Last Update Posted (Actual)

June 30, 2026

Last Update Submitted That Met QC Criteria

June 23, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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