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Blood test may predict COVID-19 severity, study finds

NCT ID NCT07466524

Knowledge-focused Sponsor: ViroGates A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether a blood test measuring suPAR levels can predict which adults hospitalized with COVID-19 will develop severe breathing failure requiring a breathing tube. Researchers analyzed stored blood samples from about 367 patients. The goal was to see if a suPAR level of 6 ng/mL or higher could identify high-risk patients early, potentially helping doctors make better treatment decisions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

367 people

The number who actually took part.

Started

Feb 2020

Finished

Oct 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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).

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome adult acute respiratory distress syndrome COVID-19 respiratory failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute respiratory distress syndrome COVID-19 Severe respiratory distress syndrome

Contacts and locations

Locations

  • Michigan state university, Department of Biostatistics

    Ann Arbor, Michigan, 48109, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.