NCT07675265

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
31mo left

Started Jul 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Jul 2026Mar 2029

First Submitted

Initial submission to the registry

June 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 30, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

June 30, 2026

Status Verified

June 1, 2026

Enrollment Period

2.4 years

First QC Date

June 23, 2026

Last Update Submit

June 23, 2026

Conditions

ARDS (Acute Respiratory Distress Syndrome)

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with an ARDS Diagnosis

    Adults with clinically defined ARDS receiving ICU-level care

    from enrollment to 28-day in-hospital mortality

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with clinically defined acute respiratory distress syndrome (ARDS)

You may qualify if:

  • 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

You may not qualify if:

  • Primary cardiogenic pulmonary edema

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2026

First Posted

June 30, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

March 1, 2029

Last Updated

June 30, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share