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 range18 Years

SexALL

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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).

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