ARDS (Acute Respiratory Distress Syndrome)OBSERVE-ARDSNCT07675265
Observational, Non-interventional Biomarker and Endotyping Study
An observational study of ARDS (Acute Respiratory Distress Syndrome), run by Prenosis, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS (Acute Respiratory Distress Syndrome)
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2026to Mar 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with clinically defined acute respiratory distress syndrome (ARDS)
Who may be able to join
- 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
Who cannot join
- Primary cardiogenic pulmonary edema
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Carle Foundation Hospital
Urbana, Illinois, 61801
Benjamin Davis, Associate Medical Director, MD, 2173776109, benjamin.davis@carle.com
About this study
Official title: 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.
- Medical subject headings
- Acute Lung Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with an ARDS Diagnosis
Adults with clinically defined ARDS receiving ICU-level care
Measured: from enrollment to 28-day in-hospital mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start14 Sep 2026
- Primary completionDec 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS (Acute Respiratory Distress Syndrome)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prenosis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07675265
- Sponsor's protocol ID
- CLN-10
- Other IDs
- 75A50125C00016
- Acronym
- OBSERVE-ARDS
- Status last verified
- Sep 2026
- First submitted
- 23 Jun 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No