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_TEST
    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.

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 Study
    The 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)

FacilityCityStateZIPSite coordinators
Michigan state university, Department of BiostatisticsAnn ArborMichigan48109-

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