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suPAR Michigan M2C2 Heterogeneity Validation Cohort Study

CompletedN/A

Sponsor: ViroGates A/S

Conditions: COVID-19, Severe Respiratory Distress Syndrome, Acute Respiratory Distress Syndrome

Interventions: suPARnostic® TurbiLatex Assay on Roche cobas c501

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

* 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).

Locations (1)

Ann Arbor, Michigan, United States