Enhanced Triage for COVID-19 to Validate the Rapid Acute Lung Injury Diagnostic (RALI-Dx) Test
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 806
- Locations
- 3
- Primary Endpoint
- Predictive Accuracy of Biomarkers for Risk Stratification
Study Overview
Brief Summary
This study is to evaluate of the accuracy of biomarkers (i.e. circulating endothelial and immune activation markers) that indicate progression to severe disease in patients with suspected COVID-19 in the Emergency Department. It is a prospective observational study of patients presenting to emergency departments with a clinical suspicion of COVID19. All participants will have plasma samples collected for biomarker analysis, and will be tested for SARS-CoV-2 infection with a nasopharyngeal swab. Participants will be managed according to the best local practices.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients presenting with clinical suspicion of COVID-19 infection, as per UHN case definition at the time of presentation
- •Age >18 years
- •Ability to provide verbal informed consent
Exclusion Criteria
- •Patients who are not suspected of COVID-19 infection, as per UHN definition at the time of presentation
Outcomes
Primary Outcomes
Predictive Accuracy of Biomarkers for Risk Stratification
Time Frame: 28 days
Given the expected clinical utility, we will use likelihood ratios (LRs) as our target milestone. +LR = (test sensitivity)/(1-test specificity); -LR= (1- sensitivity)/specificity. We will conservatively target benchmarks of +LR\>5 for a disposition towards and a -LR\<0.1 for a disposition away from mortality risk.
Secondary Outcomes
- Performance of Biomarkers as Indicators of Clinical Severity: Disposition post-ED visit (admitted vs discharged home vs discharged home and readmitted)(28 days)
- Performance of Biomarkers as Indicators of Clinical Severity: Hospital and ICU length of stay(28 days)
- Performance of Biomarkers as Indicators of Clinical Severity: Need for artificial respiratory support or hemodynamic support (mechanical ventilation, ECLS)(28 days)