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

Primary Purpose

Covid19

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Spartan COVID-19 Platform
Sponsored by
Ottawa Heart Institute Research Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Ottawa Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Patients consulted upon by ICU, internal medicine, or cardiology for hospital admission

patients undergoing cardiac testing/procedures

patients awaiting surgery

Health Care Workers

Arm Description

All patients will have both standard care and point-of-care (experimental) NP swabs performed.

All patients will have both standard care and point-of-care (experimental) NP swabs performed.

All patients will have both standard care and point-of-care (experimental) NP swabs performed.

Health Care Workers who are being screened for COVID-19 will have both standard care and point-of-care NP swabs performed.

Outcomes

Primary Outcome Measures

Sensitivity of POC testing as compared to core lab testing
Specificity, positive/negative predictive values will be derived

Secondary Outcome Measures

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

Full Information

First Posted
February 19, 2021
Last Updated
April 25, 2022
Sponsor
Ottawa Heart Institute Research Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04767958
Brief Title
The RAPID COVID Study - Application of Point-of-Care COVID-19 Testing
Acronym
RAPID COVID
Official Title
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
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
Device pulled from market due to inconsistent results.
Study Start Date
March 19, 2021 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Heart Institute Research Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a cohort study of participants falling into one of four groups.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients consulted upon by ICU, internal medicine, or cardiology for hospital admission
Arm Type
Experimental
Arm Description
All patients will have both standard care and point-of-care (experimental) NP swabs performed.
Arm Title
patients undergoing cardiac testing/procedures
Arm Type
Experimental
Arm Description
All patients will have both standard care and point-of-care (experimental) NP swabs performed.
Arm Title
patients awaiting surgery
Arm Type
Experimental
Arm Description
All patients will have both standard care and point-of-care (experimental) NP swabs performed.
Arm Title
Health Care Workers
Arm Type
Experimental
Arm Description
Health Care Workers who are being screened for COVID-19 will have both standard care and point-of-care NP swabs performed.
Intervention Type
Diagnostic Test
Intervention Name(s)
Spartan COVID-19 Platform
Intervention Description
Nasal-pharyngeal swab for testing on the Spartan Covid-19 platform
Primary Outcome Measure Information:
Title
Sensitivity of POC testing as compared to core lab testing
Description
Specificity, positive/negative predictive values will be derived
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Incidence in which decision making would have been altered by POC testing
Description
examples include: ventilation decisions, use of ICU/isolation rooms, use of PPE, additional testing
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
In hospital outcomes
Description
In hospital outcomes include death, pneumonia, intubation, myocardial infarction, urgent revascularization,mechanical device support, transplant
Time Frame
16 months
Title
Length of hospital admission
Description
Total number of days in hospital will be collected
Time Frame
16 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y4W7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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