The RAPID COVID Study - Application of Point-of-Care COVID-19 Testing to Optimize Patient Care, Resource Allocation and Safety for Frontline Staff
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- Ottawa Heart Institute Research Corporation
- Enrollment
- 89
- Locations
- 1
- Primary Endpoint
- Sensitivity of POC testing as compared to core lab testing
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Sensitivity of POC testing as compared to core lab testing
Time Frame: 3 months
Specificity, positive/negative predictive values will be derived
Secondary Outcomes
- Incidence in which decision making would have been altered by POC testing(12 months)