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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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This study aims to enroll patients 18 years or older, presenting to Emergency Rooms or COVID-19 Assessment Centers with clinical suspicion of COVID-19 infection.
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| Name | Affiliation | Role |
|---|---|---|
| Shahid Husain, MD MS | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pontifícia Universidade Católica do Rio Grande do Sul | Porto Alegre | Brazil | ||||
| University Health Network |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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A blood sample will be collected in an EDTA tube for biomarker analysis.
| 28 days |
| Performance of Biomarkers as Indicators of Clinical Severity: Need for artificial respiratory support or hemodynamic support (mechanical ventilation, ECLS) | 28 days |
| Toronto |
| Ontario |
| M5G 2C4 |
| Canada |
| Cittá della Salute e della Scienza di Torino Hospital-Molinette Site | Turin | Italy |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |