suPAR Michigan M2C2 Heterogeneity Validation Cohort Study

March 19, 2026 updated by: ViroGates A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

367

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Michigan state university, Department of Biostatistics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

  • Inclusion Criteria

    1. Age ≥18 years at hospital admission.
    2. Confirmed SARS CoV 2 infection documented in the EHR (positive RT PCR or antigen test from a respiratory specimen).
    3. suPAR level measured from EDTA plasma using the suPARnostic TurbiLatex assay on a Roche cobas c501 analyzer on samples taken within 24 hours of Emergency Department presentation or hospital admission.
    4. Available 30 day follow up data from the date of admission (30 day vital status and SRF status ascertainable).

  • Exclusion Criteria

    1. Already intubated and/or receiving invasive mechanical ventilation at the time of suPAR sample collection.
    2. Documented "Do Not Intubate" order or determination that the patient was not a candidate for mechanical ventilation at admission.
    3. suPAR measured by a method other than the suPARnostic TurbiLatex assay on Roche cobas c501 (e.g., ELISA, other platforms).
    4. Incomplete primary endpoint data (SRF status cannot be determined within 30 days).
    5. Patients with confirmed SARS CoV 2 infection who were not primarily admitted for COVID 19 (incidental positive test in a non COVID admission).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severe respiratory failure (SRF) within 30 days
Time Frame: Statistical analysis will be carried out in March 2026
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.
Statistical analysis will be carried out in March 2026

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary outcomes (optional)
Time Frame: March 2026
Compare performance to European SPARCOL cohort
March 2026
Subgroup analysis
Time Frame: March 2026
Evaluate performance across subgroups (sex, age, race/ethnicity, BMI, diabetes, CKD, SARS-CoV-2 variant era).
March 2026
Composite endpoint
Time Frame: March 2026
Evaluate suPAR ≥6 ng/mL for ICU admission, 30-day mortality, and composite (SRF or death).
March 2026

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ViroGates A/S

Collaborators

University of Michigan
The University of Texas Medical Branch, Galveston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

October 19, 2022

Study Completion (Actual)

October 19, 2022

Study Registration Dates

First Submitted

February 18, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VG-001-Michigan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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