Recruiting

Observational Study

Sponsor:

Prenosis, Inc.

Code:

NCT07675265

Conditions

ARDS (Acute Respiratory Distress Syndrome)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

ARDS (Acute Respiratory Distress Syndrome)

Study ID

NCT07675265

Start date

Sep 14, 2026

Status verified date

Sep, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1200 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Number of Participants with an ARDS Diagnosis [ Time Frame: from enrollment to 28-day in-hospital mortality ]

Central Contacts and Locations

Locations

Carle Foundation Hospital

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Benjamin Davis, Associate Medical Director, MD

2173776109benjamin.davis@carle.com

More Information

Sponsor

Prenosis, Inc.

Last update posted

Sep 28, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-29. This information was provided to ClinicalTrials.gov by Prenosis, Inc. on 2026-09-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.