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

Overview

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.

Full Title of Study: “The RAPID COVID Study – Application of Point-of-Care COVID-19 Testing to Optimize Patient Care, Resource Allocation and Safety for Frontline Staff”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 28, 2022

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 Test: Spartan COVID-19 Platform
    • Nasal-pharyngeal swab for testing on the Spartan Covid-19 platform

Arms, Groups and Cohorts

  • Experimental: Patients consulted upon by ICU, internal medicine, or cardiology for hospital admission
    • All patients will have both standard care and point-of-care (experimental) NP swabs performed.
  • Experimental: patients undergoing cardiac testing/procedures
    • All patients will have both standard care and point-of-care (experimental) NP swabs performed.
  • Experimental: patients awaiting surgery
    • All patients will have both standard care and point-of-care (experimental) NP swabs performed.
  • Experimental: Health Care Workers
    • Health Care Workers who are being screened for COVID-19 will have both standard care and point-of-care NP swabs performed.

Clinical Trial Outcome Measures

Primary Measures

  • Sensitivity of POC testing as compared to core lab testing
    • Time Frame: 3 months
    • Specificity, positive/negative predictive values will be derived

Secondary Measures

  • Incidence in which decision making would have been altered by POC testing
    • Time Frame: 12 months
    • examples include: ventilation decisions, use of ICU/isolation rooms, use of PPE, additional testing

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ottawa Heart Institute Research Corporation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Dr. Derek So, 613-696-7000, dso@ottawaheart.ca

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