Biorepository and endotyping study for ARDS patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study collects longitudinal biospecimens and harmonized clinical data from adults with ARDS to build unsupervised, therapy-agnostic endotyping algorithms and unsupervised, therapy-specific treatment-prediction models over two years. It is non-interventional and observational, focusing on biomarker discovery and data-driven patient subtyping. Eligible participants are adults with acute ARDS diagnosed within seven days, requiring ICU admission and receiving oxygen support or mechanical ventilation. Data and specimens are gathered to enable centralized analysis and algorithm development across participating sites, under sponsor Prenosis, Inc. with support from BARDA and a collaborating hospital system.

Why it matters

Who can join: the full rules

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

Where it's running

• Carle Foundation Hospital
  Urbana, Illinois, United States Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pulse Wave vs Saline Bolus EIT to measure lung perfusion in ARDS

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• BAL balance: ARDS through lung lavage and imaging to find different ARDS types

  This study tests how bronchoalveolar lavage fluid and chest CT imaging can reveal different ARDS subtypes in adults with ARDS or severe pneumonia in the ICU.

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• Titrating PEEP in ARDS: Manual chest compression vs. electrical impedance tomography

  In adults with ARDS on mechanical ventilation, the study tests whether a simple manual chest compression method can set the right PEEP as well as electrical impedance tomography (EIT).

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• Individualized PEEP Titration in ARDS Based on Lung Recruitment Potential

  This pilot study tests two personalized PEEP strategies in adults with ARDS to see which approach better supports breathing mechanics by using a recruitment potential measure.

  Recruiting Hospital Dr. Franco Ravera Zunino · Rancagua, Región del Libertador General Bernardo O’Higgins · NCT07603310

• Single-dose inhaled rh-KGF-2 for ARDS in adults

  This trial tests whether a single inhaled dose of rh-KGF-2 helps adults with ARDS who are on ventilators, using three dose levels to see which is safest and potentially most effective.

  Recruiting Early Phase 1 Shanghai Zhongshan Hospital · Shanghai, Shanghai Municipality · NCT07558538

• HT31-1 for ARDS: a first-in-human test of a monoclonal antibody

  This early study tests whether HT31-1, a monoclonal antibody, is safe and how it behaves in the body in healthy adults, with a plan to move into ARDS patients later.

  Recruiting Phase 1 HTIC, Inc · Richmond, Virginia and 1 other locations · NCT07449572

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.