CompletedNot Applicable

suPAR Michigan M2C2 Heterogeneity Validation Cohort Study

United States367 participantsStarted 2020-02-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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).

Exclusion criteria

. 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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Severe respiratory failure (SRF) within 30 days

Timeframe: Statistical analysis will be carried out in March 2026

Trial details

NCT IDNCT07466524

SponsorViroGates A/S

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-10-19

View on ClinicalTrials.gov More COVID-19 trials