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 Type
OBSERVATIONAL
Enrollment
806
Pontifícia Universidade Católica do Rio Grande do Sul
Porto Alegre, Brazil
University Health Network
Toronto, Ontario, Canada
Cittá della Salute e della Scienza di Torino Hospital-Molinette Site
Turin, Italy
Predictive Accuracy of Biomarkers for Risk Stratification
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.
Time frame: 28 days
Performance of Biomarkers as Indicators of Clinical Severity: Disposition post-ED visit (admitted vs discharged home vs discharged home and readmitted)
Time frame: 28 days
Performance of Biomarkers as Indicators of Clinical Severity: Hospital and ICU length of stay
Time frame: 28 days
Performance of Biomarkers as Indicators of Clinical Severity: Need for artificial respiratory support or hemodynamic support (mechanical ventilation, ECLS)
Time frame: 28 days
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