Covid19
Conditions
Brief summary
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.
Detailed description
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: 1. patients consulted upon by ICU, internal medicine, or cardiology for admission to the hospital 2. patients undergoing cardiac testing and/or procedures 3. patients awaiting surgery The results from the POC test will be compared to the results from the traditional hospital core lab test to determine sensitivity and specificity of the POC test. 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.
Interventions
DIAGNOSTIC_TESTSpartan COVID-19 Platform
Nasal-pharyngeal swab for testing on the Spartan Covid-19 platform
Sponsors
Ottawa Heart Institute Research Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
This is a cohort study of participants falling into one of four groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* participants \>/= 18 years of age * patients for whom POC testing would change their course of treatment (in opinion of treatment team)
Exclusion criteria
* patients in whom conventional COVID-19 testing would not have otherwise been performed * patients in whom immediate COVID-19 testing would not alter short-term treatment * patients who refuse consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of POC testing as compared to core lab testing | 3 months | Specificity, positive/negative predictive values will be derived |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence in which decision making would have been altered by POC testing | 12 months | examples include: ventilation decisions, use of ICU/isolation rooms, use of PPE, additional testing |
Other
| Measure | Time frame | Description |
|---|---|---|
| In hospital outcomes | 16 months | In hospital outcomes include death, pneumonia, intubation, myocardial infarction, urgent revascularization,mechanical device support, transplant |
| Length of hospital admission | 16 months | Total number of days in hospital will be collected |
Countries
Canada
Outcome results
None listed