COVID-19NCT07466524
suPAR Michigan M2C2 Heterogeneity Validation Cohort Study
An observational study of COVID-19 and Severe Respiratory Distress Syndrome, run by ViroGates A/S at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Severe Respiratory Distress Syndrome, Acute Respiratory Distress Syndrome
- What is being tested?
- suPARnostic® TurbiLatex Assay on Roche cobas c501
- How many people
- 367 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to 19 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age ≥18 years at hospital admission.
- Confirmed SARS CoV 2 infection documented in the EHR (positive RT PCR or antigen test from a respiratory specimen).
- 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.
- Available 30 day follow up data from the date of admission (30 day vital status and SRF status ascertainable).
Who cannot join
- Already intubated and/or receiving invasive mechanical ventilation at the time of suPAR sample collection.
- Documented "Do Not Intubate" order or determination that the patient was not a candidate for mechanical ventilation at admission.
- suPAR measured by a method other than the suPARnostic TurbiLatex assay on Roche cobas c501 (e.g., ELISA, other platforms).
- Incomplete primary endpoint data (SRF status cannot be determined within 30 days).
- Patients with confirmed SARS CoV 2 infection who were not primarily admitted for COVID 19 (incidental positive test in a non COVID admission).
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan state university, Department of Biostatistics
Ann Arbor, Michigan, 48109
About this study
Official title: 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.
Read the 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
- Hayek SS, Vasb inder A, Engoren M, et al. J Med Virol. 2024; 96(1):e29389. PMID: 38235904.
- Chalkias A, Skoulakis A, Papagiannakis N, et al. Eur J Clin Invest. 022;52(7):e13794. PMID: 35435245.
- Altintas I, Eugen-Olsen J, Seppala S, et al. Biomark Insights. 2021;16. PMID: 34421295.
- Peduzzi P, Concato J, Kemper E, et al. J Clin Epidemiol. 1996; 49(12):1373-1379.
- FDA Q-Sub Q240207/A001 Meeting Minutes, April 15, 2024.
- Hanley JA, McNeil BJ. Radiology. 1982;143(1):29-36.
- Being tested
- suPARnostic® TurbiLatex Assay on Roche cobas c501
- Keywords
- Soluble urokinase plasminogen activator receptor, suPAR, Respiratory failure, Mechanical ventilation, Biomarker, Real world data, Observational Cohort study
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suPARnostic® TurbiLatex Assay on Roche cobas c501Diagnostic 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: suPARnostic® TurbiLatex Assay on Roche cobas c501 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Statistical analysis will be carried out in March 2026
Secondary outcomes (3)
Secondary outcomes (optional)
Compare performance to European SPARCOL cohort
Measured: March 2026
Subgroup analysis
Evaluate performance across subgroups (sex, age, race/ethnicity, BMI, diabetes, CKD, SARS-CoV-2 variant era).
Measured: March 2026
Composite endpoint
Evaluate suPAR ≥6 ng/mL for ICU admission, 30-day mortality, and composite (SRF or death).
Measured: March 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Feb 2020
- Primary completion19 Oct 2022
- Study completion19 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 367 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViroGates A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Michigan, The University of Texas Medical Branch, Galveston
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466524
- Sponsor's protocol ID
- VG-001-Michigan
- Status last verified
- Mar 2026
- First submitted
- 18 Feb 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Vasbinder A, Anderson E, Shadid H, Berlin H, Pan M, Azam TU, Khaleel I, Padalia K, Meloche C, O'Hayer P, Michaud E, Catalan T, Feroze R, Blakely P, Launius C, Huang Y, Zhao L, Ang L, Mikhael M, Mizokami-Stout K, Pennathur S, Kretzler M, Loosen SH, Chalkias A, Tacke F, Giamarellos-Bourboulis EJ, Reiser J, Eugen-Olsen J, Feldman EL, Pop-Busui R, Hayek SS; ISIC Study Group. Inflammation, Hyperglycemia, and Adverse Outcomes in Individuals With Diabetes Mellitus Hospitalized for COVID-19. Diabetes Care. 2022 Mar 1;45(3):692-700. doi: 10.2337/dc21-2102.
PubMed 35045184Ismail A, Shadid HR, Huang Y, Hutten CG, Vasbinder A, Pizzo I, Catalan TC, Diaz KM, Kunkle P, Banerjee M, Rubenfire M, Brandt EJ, Williams G, Pop-Busui R, Hayek SS. Statin Therapy, Inflammation, and Outcomes in Patients Hospitalized for COVID-19: A Prospective Multicenter Cohort Study. Am J Med. 2024 Dec;137(12):1264-1271.e1. doi: 10.1016/j.amjmed.2024.08.011. Epub 2024 Aug 22.
PubMed 39179167Hutten CG, Padalia K, Vasbinder A, Huang Y, Ismail A, Pizzo I, Machado Diaz K, Catalan T, Presswalla F, Anderson E, Erne G, Bitterman B, Blakely P, Giamarellos-Bourboulis EJ, Loosen SH, Tacke F, Chalkias A, Reiser J, Eugen-Olsen J, Banerjee M, Pop-Busui R, Hayek SS. Obesity, Inflammation, and Clinical Outcomes in COVID-19: A Multicenter Prospective Cohort Study. J Clin Endocrinol Metab. 2024 Oct 15;109(11):2745-2753. doi: 10.1210/clinem/dgae273.
PubMed 38635301Vasbinder A, Padalia K, Pizzo I, Machado K, Catalan T, Presswalla F, Anderson E, Ismail A, Hutten C, Huang Y, Blakely P, Azam TU, Berlin H, Feroze R, Launius C, Meloche C, Michaud E, O'Hayer P, Pan M, Shadid HR, Rasmussen LJH, Roberts DA, Zhao L, Banerjee M, Murthy V, Loosen SH, Chalkias A, Tacke F, Reiser J, Giamarellos-Bourboulis EJ, Eugen-Olsen J, Pop-Busui R, Hayek SS; ISIC investigators. SuPAR, biomarkers of inflammation, and severe outcomes in patients hospitalized for COVID-19: The International Study of Inflammation in COVID-19. J Med Virol. 2024 Jan;96(1):e29389. doi: 10.1002/jmv.29389.
PubMed 38235904
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- suPAR ≥6 ng/mL for Predicting Severe Respiratory Failure in U.S. Adults Hospitalized With COVID 19 (suPAR US The Michigan Cohort Heterogeneity Study)
- ClinicalTrials.gov ID
- NCT07466524
- Acronym / sponsor ID
- VG-001-Michigan
- Keywords
- Soluble urokinase plasminogen activator receptor, suPAR, Respiratory failure, Mechanical ventilation, Biomarker, Real world data, Observational Cohort study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 367 participants (actual)
- Lead sponsor
- ViroGates A/SIndustry (pharma, biotech, devices)
- Collaborators
- University of Michigan, The University of Texas Medical Branch, Galveston
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 19 Oct 2022 (actual)
- Study completion
- 19 Oct 2022 (actual)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Hayek SS, Vasb inder A, Engoren M, et al. J Med Virol. 2024; 96(1):e29389. PMID: 38235904.
- Chalkias A, Skoulakis A, Papagiannakis N, et al. Eur J Clin Invest. 022;52(7):e13794. PMID: 35435245.
- Altintas I, Eugen-Olsen J, Seppala S, et al. Biomark Insights. 2021;16. PMID: 34421295.
- Peduzzi P, Concato J, Kemper E, et al. J Clin Epidemiol. 1996; 49(12):1373-1379.
- FDA Q-Sub Q240207/A001 Meeting Minutes, April 15, 2024.
- Hanley JA, McNeil BJ. Radiology. 1982;143(1):29-36.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Michigan Medicine Cohort Study | – | Diagnostic Test: suPARnostic® TurbiLatex Assay on Roche cobas c501The Michigan Medicine Cohort (M2C2) is part of the International Study of Inflammation in COVID-19 (ISIC), ClinicalTrials.gov ID NCT04818866 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
Key exclusion criteria (5 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| suPARnostic® TurbiLatex Assay on Roche cobas c501Quantitative 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. | Diagnostic test | Michigan Medicine Cohort Study |
Primary outcome
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.
3 secondary outcomes
Secondary outcomes (optional)
Time frame: March 2026
Subgroup analysis
Time frame: March 2026
Composite endpoint
Time frame: March 2026
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Results publication: PubMed 35045184Vasbinder A, Anderson E, Shadid H, Berlin H, Pan M, Azam TU, Khaleel I, Padalia K, Meloche C, O'Hayer P, Michaud E, Catalan T, Feroze R, Blakely P, Launius C, Huang Y, Zhao L, Ang L, Mikhael M, Mizokami-Stout K, Pennathur S, Kretzler M, Loosen SH, Chalkias A, Tacke F, Giamarellos-Bourboulis EJ, Reiser J, Eugen-Olsen J, Feldman EL, Pop-Busui R, Hayek SS; ISIC Study Group. Inflammation, Hyperglycemia, and Adverse Outcomes in Individuals With Diabetes Mellitus Hospitalized for COVID-19. Diabetes Care. 2022 Mar 1;45(3):692-700. doi: 10.2337/dc21-2102.
- Results publication: PubMed 39179167Ismail A, Shadid HR, Huang Y, Hutten CG, Vasbinder A, Pizzo I, Catalan TC, Diaz KM, Kunkle P, Banerjee M, Rubenfire M, Brandt EJ, Williams G, Pop-Busui R, Hayek SS. Statin Therapy, Inflammation, and Outcomes in Patients Hospitalized for COVID-19: A Prospective Multicenter Cohort Study. Am J Med. 2024 Dec;137(12):1264-1271.e1. doi: 10.1016/j.amjmed.2024.08.011. Epub 2024 Aug 22.
- Results publication: PubMed 38635301Hutten CG, Padalia K, Vasbinder A, Huang Y, Ismail A, Pizzo I, Machado Diaz K, Catalan T, Presswalla F, Anderson E, Erne G, Bitterman B, Blakely P, Giamarellos-Bourboulis EJ, Loosen SH, Tacke F, Chalkias A, Reiser J, Eugen-Olsen J, Banerjee M, Pop-Busui R, Hayek SS. Obesity, Inflammation, and Clinical Outcomes in COVID-19: A Multicenter Prospective Cohort Study. J Clin Endocrinol Metab. 2024 Oct 15;109(11):2745-2753. doi: 10.1210/clinem/dgae273.
- Results publication: PubMed 38235904Vasbinder A, Padalia K, Pizzo I, Machado K, Catalan T, Presswalla F, Anderson E, Ismail A, Hutten C, Huang Y, Blakely P, Azam TU, Berlin H, Feroze R, Launius C, Meloche C, Michaud E, O'Hayer P, Pan M, Shadid HR, Rasmussen LJH, Roberts DA, Zhao L, Banerjee M, Murthy V, Loosen SH, Chalkias A, Tacke F, Reiser J, Giamarellos-Bourboulis EJ, Eugen-Olsen J, Pop-Busui R, Hayek SS; ISIC investigators. SuPAR, biomarkers of inflammation, and severe outcomes in patients hospitalized for COVID-19: The International Study of Inflammation in COVID-19. J Med Virol. 2024 Jan;96(1):e29389. doi: 10.1002/jmv.29389.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Severe Respiratory Distress Syndrome, run by ViroGates A/S at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe respiratory failure (SRF) within 30 days (time frame: Statistical analysis will be carried out in March 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07466524, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.