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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Biomarker Study for the Evaluation of Response and Validation of Endotypes in Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT07675265
- Acronym / sponsor ID
- OBSERVE-ARDS / CLN-10
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Prenosis, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 14 Sep 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with clinically defined acute respiratory distress syndrome (ARDS)
Key inclusion criteria (8 listed)
- Age ≥18 years
- ARDS Diagnosis (New Global Definition of ARDS)
- Timing: Acute onset within 7 days
- Radiology: Bilateral pulmonary opacities
- Hypoxia:
Key exclusion criteria (1 listed)
- Primary cardiogenic pulmonary edema
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS (Acute Respiratory Distress Syndrome), run by Prenosis, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with an ARDS Diagnosis (time frame: from enrollment to 28-day in-hospital mortality). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.