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suPAR Michigan M2C2 Heterogeneity Validation Cohort Study

NCT07466524 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 367

Last updated 2026-03-20

No results posted yet for this study

Summary

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.

Conditions

  • COVID-19
  • Severe Respiratory Distress Syndrome
  • Acute Respiratory Distress Syndrome

Interventions

DIAGNOSTIC_TEST

suPARnostic® TurbiLatex Assay on Roche cobas c501

Quantitative 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.

Sponsors & Collaborators

  • University of Michigan

    collaborator OTHER

  • The University of Texas Medical Branch, Galveston

    collaborator OTHER

  • ViroGates A/S

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2022-10-19
Completion
2022-10-19
FDA Device
Yes

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07466524 on ClinicalTrials.gov