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

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

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.

Study Overview

• Status: Terminated
• Conditions: Covid19
• Intervention / Treatment: Diagnostic test: Spartan COVID-19 Platform

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.

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y4W7
      • University of Ottawa Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Diagnostic test: Spartan COVID-19 Platform; Nasal-pharyngeal swab for testing on the Spartan Covid-19 platform
EXPERIMENTAL: patients undergoing cardiac testing/procedures; All patients will have both standard care and point-of-care (experimental) NP swabs performed.	Diagnostic test: Spartan COVID-19 Platform; Nasal-pharyngeal swab for testing on the Spartan Covid-19 platform
EXPERIMENTAL: patients awaiting surgery; All patients will have both standard care and point-of-care (experimental) NP swabs performed.	Diagnostic test: Spartan COVID-19 Platform; Nasal-pharyngeal swab for testing on the Spartan Covid-19 platform
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.	Diagnostic test: Spartan COVID-19 Platform; Nasal-pharyngeal swab for testing on the Spartan Covid-19 platform

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	Total number of days in hospital will be collected	16 months

Collaborators and Investigators

• Sponsor: Ottawa Heart Institute Research Corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 19, 2021
• Primary Completion (ACTUAL): May 31, 2021
• Study Completion (ACTUAL): August 31, 2021

Study Registration Dates

• First Submitted: February 19, 2021
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (ACTUAL): February 23, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 25, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 20200858-01T

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No