The RAPID COVID Study - Application of Point-of-Care COVID-19 Testing

Study Overview
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Brief Summary
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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.

Detailed Description
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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: patients consulted upon by ICU, internal medicine, or cardiology for admission to the hospital patients undergoing cardiac testing and/or procedures 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.

Official Title
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The RAPID COVID Study - Application of Point-of-Care COVID-19 Testing to Optimize Patient Care, Resource Allocation and Safety for Frontline Staff

Conditions
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Covid19

Intervention / Treatment
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* Diagnostic Test: Spartan COVID-19 Platform


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: This is a cohort study of participants falling into one of four groups.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients consulted upon by ICU, internal medicine, or cardiology for hospital admission<br>All patients will have both standard care and point-of-care (experimental) NP swabs performed. | Diagnostic Test: Spartan COVID-19 Platform<br>* Nasal-pharyngeal swab for testing on the Spartan Covid-19 platform<br>|
| Experimental: patients undergoing cardiac testing/procedures<br>All patients will have both standard care and point-of-care (experimental) NP swabs performed. | Diagnostic Test: Spartan COVID-19 Platform<br>* Nasal-pharyngeal swab for testing on the Spartan Covid-19 platform<br>|
| Experimental: patients awaiting surgery<br>All patients will have both standard care and point-of-care (experimental) NP swabs performed. | Diagnostic Test: Spartan COVID-19 Platform<br>* Nasal-pharyngeal swab for testing on the Spartan Covid-19 platform<br>|
| Experimental: Health Care Workers<br>Health Care Workers who are being screened for COVID-19 will have both standard care and point-of-care NP swabs performed. | Diagnostic Test: Spartan COVID-19 Platform<br>* Nasal-pharyngeal swab for testing on the Spartan Covid-19 platform<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of POC testing as compared to core lab testing | Specificity, positive/negative predictive values will be derived | 3 months | 

Secondary Outcome Measures

| Outcome Measure | 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 |