suPAR Michigan M2C2 Heterogeneity Validation Cohort Study
Part of paid clinical trials in Ann Arbor, Michigan.
- Sponsor
- ViroGates A/S
- Study ID
- NCT07466524
- Status
- Completed
Conditions
- Acute Respiratory Distress Syndrome
- COVID-19
- Severe Respiratory Distress Syndrome
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- suPARnostic® TurbiLatex Assay on Roche cobas c501 — DIAGNOSTIC_TESTQuantitative measurement of soluble urokinase plasminogen activator receptor (suPAR) in human EDTA plasma using the suPARnostic TurbiLatex particle enhanced turbidimetric immunoassay performed on the Roche Diagnostics cobas c501 analyzer. Results are reported in ng/mL and interpreted using a pre specified clinical threshold of 6 ng/mL to identify patients at increased risk for progression to severe respiratory failure.
Study Details
This is a retrospective, non interventional cohort study using stored plasma samples from appoximately 300 adults hospitalized with confirmed COVID 19. Baseline suPAR measured using the suPARnostic TurbiLatex assay on the Roche cobas c501.
Key Dates
- Start date
- Feb 1, 2020
- Status verified
- Mar 2026
- Primary completion
- Oct 19, 2022
- Completion
- Oct 19, 2022
Study Design
- Enrollment
- 367 participants (actual)
Arms
- Arm: Michigan Medicine Cohort StudyThe Michigan Medicine Cohort (M2C2) is part of the International Study of Inflammation in COVID-19 (ISIC), ClinicalTrials.gov ID NCT04818866
Primary Outcome Measure
Severe respiratory failure (SRF) within 30 days [ Time Frame: Statistical analysis will be carried out in March 2026 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Michigan state university, Department of Biostatistics | Ann Arbor | Michigan | 48109 | - |
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