An observational study in COVID-19, Severe Respiratory Distress Syndrome and Acute Respiratory Distress Syndrome, sponsored by ViroGates A/S. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-20.
Sponsored by ViroGates A/S · Observational
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.
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
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
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 367 is above the median of 260 across 3,135 observational studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with ViroGates A/S as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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 clinical practice and includes racially and ethnically diverse populations with typical U.S. burdens of obesity, diabetes, and chronic kidney disease.
Age ≥18 years at hospital admission.
Already intubated and/or receiving invasive mechanical ventilation at the time of suPAR sample collection.
The Michigan Medicine Cohort (M2C2) is part of the International Study of Inflammation in COVID-19 (ISIC), ClinicalTrials.gov ID NCT04818866
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.
Severe respiratory failure (SRF) within 30 days
Development of severe respiratory failure requiring endotracheal intubation and initiation of invasive mechanical ventilation within 30 days of hospital admission. SRF is ascertained from EHR procedure codes and clinical documentation. Performance metrics (sensitivity, specificity, PPV, NPV, AUC) at the suPAR ≥6 ng/mL threshold will be calculated.
Time frame: Statistical analysis will be carried out in March 2026
Secondary outcomes (optional)
Compare performance to European SPARCOL cohort
Time frame: March 2026
Subgroup analysis
Evaluate performance across subgroups (sex, age, race/ethnicity, BMI, diabetes, CKD, SARS-CoV-2 variant era).
Time frame: March 2026
Composite endpoint
Evaluate suPAR ≥6 ng/mL for ICU admission, 30-day mortality, and composite (SRF or death).
Time frame: March 2026
Plan to share: Undecided
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