NCT07466524

suPAR Michigan M2C2 Heterogeneity Validation Cohort Study

suPAR ≥6 ng/mL for Predicting Severe Respiratory Failure in U.S. Adults Hospitalized With COVID 19 (suPAR US The Michigan Cohort Heterogeneity Study)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 367 (actual)
• Sponsor: ViroGates A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The Michigan Medicine COVID-19 Cohort (M2C2) is the largest sub-cohort of the International Study on Inflammation in COVID-19 (ISIC). The M2C2 comprises consecutive, systematically enrolled adults (≥18 years) with confirmed SARS-CoV-2 infection hospitalized specifically for COVID-19 at the University of Michigan from 1 February 2020 to 1 June 2021. Adult patients hospitalized in participating U.S. hospitals with confirmed COVID 19 infection during the study period, who had baseline suPAR measured using the suPARnostic TurbiLatex assay on Roche cobas c501 on plasma samples obtained within 48 hours of admission. The cohort reflects real world U.S. data and includes racially and ethnically diverse populations with typical U.S. burdens of obesity, diabetes, and chronic kidney disease. SAMPLE SIZE JUSTIFICATION - Since we have a fixed 6 ng/mL threshold and are only validating (not discovering), the analysis is just a 2×2 table. True sensitivity 94% (matching SPARCOL): N=136 is enough True sensitivity 90% (conservative): N=237 is enough True sensitivity 88% (worst case): N=440 needed SPARCOL showed 93.9%, so N=300 covers you even if U.S. sensitivity drops to \~88% - a generous safety margin. STATED LIMITATIONS * N=300 does not support fully adjusted multivariable logistic regression * Hispanic and Asian subgroups are too small for standalone powered analyses. These subgroups are reported descriptively. * Formal non-inferiority testing of sensitivity (U.S. vs. SPARCOL) would require a larger sample. The comparison is performed descriptively, with the acceptance criterion applied to the U.S. data independently (lower 95% CI \> 80%). CONCLUSION We have previously considered measuring 1200 samples, but a balance between statistical rigor and practical feasibility (assay cost, data extraction effort) we recalculated number needed to N=300 which according to the power calculation is an appropriate sample size for this validation study. REFERENCES 1. Hayek SS, Vasb inder A, Engoren M, et al. J Med Virol. 2024; 96(1):e29389. PMID: 38235904. 2. Chalkias A, Skoulakis A, Papagiannakis N, et al. Eur J Clin Invest. 022;52(7):e13794. PMID: 35435245. 3. Altintas I, Eugen-Olsen J, Seppala S, et al. Biomark Insights. 2021;16. PMID: 34421295. 4. Peduzzi P, Concato J, Kemper E, et al. J Clin Epidemiol. 1996; 49(12):1373-1379. 5. FDA Q-Sub Q240207/A001 Meeting Minutes, April 15, 2024. 6. Hanley JA, McNeil BJ. Radiology. 1982;143(1):29-36.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-02-01
• Primary completion: 2022-10-19
• Completion: 2022-10-19
• First posted: 2026-03-12
• Last updated: 2026-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study