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Device pulled from market due to inconsistent results.
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This study is being conducted to study the use and application of a point-of-care (POC) Covid-19 test developed by Spartan BioSciences and recently approved for clinical use by Health Canada.
This RAPID COVID-19 study is a prospective, unblinded clinical trial. POC testing utilizing the Spartan Cube COVID-19 platform will be performed on a cohort of 2200 hospitalized patients who have been tested for COVID-19.
This cohort will be divided into three groups:
An additional cohort of 500 quarantined health care workers will have the POC test performed and compared with the results from the traditional hospital core lab test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients consulted upon by ICU, internal medicine, or cardiology for hospital admission | Experimental | All patients will have both standard care and point-of-care (experimental) NP swabs performed. |
|
| patients undergoing cardiac testing/procedures | Experimental | All patients will have both standard care and point-of-care (experimental) NP swabs performed. |
|
| patients awaiting surgery | Experimental | All patients will have both standard care and point-of-care (experimental) NP swabs performed. |
|
| Health Care Workers | Experimental | Health Care Workers who are being screened for COVID-19 will have both standard care and point-of-care NP swabs performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spartan COVID-19 Platform | Diagnostic Test | Nasal-pharyngeal swab for testing on the Spartan Covid-19 platform |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of POC testing as compared to core lab testing | Specificity, positive/negative predictive values will be derived | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence in which decision making would have been altered by POC testing | examples include: ventilation decisions, use of ICU/isolation rooms, use of PPE, additional testing | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| In hospital outcomes | In hospital outcomes include death, pneumonia, intubation, myocardial infarction, urgent revascularization,mechanical device support, transplant | 16 months |
| Length of hospital admission |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ottawa Heart Institute | Ottawa | Ontario | K1Y4W7 | Canada |
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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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This is a cohort study of participants falling into one of four groups.
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Total number of days in hospital will be collected
| 16 months |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |