PERC Health Canada COVID-19

Sponsor
University of Calgary (Other)
Overall Status
Recruiting
CT.gov ID
NCT05040763
Collaborator
Health Canada (Other)
2,882
14
1
13.7
205.9
15.1

Study Details

Study Description

Brief Summary

Although there are several licensed vaccines for SAR-CoV-2 (COVID-19) in Canada, none of them are approved for use in children under the age of 12, leaving five million children under 12 years unvaccinated. There is a need to find methods of mass rapid point of care testing in unvaccinated populations such as in schools that can be performed by a lay individual. This multi-center study will evaluate the clinical sensitivity of buccal swabs with the ID NOW COVID-19 device in comparison to standard of care COVID-19 testing at 15 pediatric emergency centres across Canada.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Buccal Swabc- Copan flocked swab
  • Diagnostic Test: Standard of Care COVID-19 swab
N/A

Detailed Description

This study will enroll approx 2882 participants under the age of 18 at 15 pediatric emergency centres across Canada. The purpose of the study is to evaluate the clinical sensitivity of buccal swab testing using Abbott ID NOW COVID-19device to detect SARS-CoV-2 infection among children aged 0-<18.0 years old presenting to the emergency department with an indication for SARS-CoV-2 testing as determined by the clinical care team. The study also seeks to identify factors that influence the accuracy of the testing approach and to examine the feasibility and perception of self/caregiver buccal swab sample collection.

In this prospective study, we will validate a self collected buccal swab that is analyzed with the Abbott ID NOW COVID-19 device against a reference RT-PCR nasal, nasopharyngeal (NP) or throat swab (or others) deemed standard of care at participating sites. The standard of care swabs will be collected by a qualified health professional and assessed by local laboratory services.

Individuals presenting to the emergency department that are identified as meeting the criteria as per local guidelines to be tested for SARS-CoV-2 (i.e. droplet precautions) will be appropriately consented and screened for participation in the study.

Eligible, consented participants will have their past medical history, COVID-19 symptom assessment, vaccination status, and physical exam findings collected from their charts.

A qualified healthcare professional will obtain a standard of care RT-PCR Swab from the participant. The results from this swab will be collected from the participants chart once available.

Depending on age, the study team will then train the participant/caregiver how to perform and obtain a buccal swab from the inside of the cheek. The collected buccal swab will be analyzed by the study team using the Abbott ID NOW COVID-19 device and results obtained within approx 15 mins.

Participants and their families will be notified of the qualitative result from the buccal swab.

Participants and their caregivers will be asked to complete pain assessment and acceptability questionnaires for both the standard of care and buccal swab tests.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2882 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
The primary objective of this study is to determine whether buccal swabs analyzed with the Abbott ID Now perform acceptably compared to standard of care COVID-19 swabsThe primary objective of this study is to determine whether buccal swabs analyzed with the Abbott ID Now perform acceptably compared to standard of care COVID-19 swabs
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
A Multi-Center Evaluation of Buccal Swabs With the Abbott ID NOW COVID-19 for Point-of-Care Detection SARS-CoV-2 in Pediatric Emergency Departments
Actual Study Start Date :
Nov 10, 2021
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: COVID-19 Swab Collection

All participants will receive standard of care COVID-19 testing in addition to buccal swab COVID-19 testing

Diagnostic Test: Buccal Swabc- Copan flocked swab
All participants will have a buccal swab sampled collected from the inside of the mouth either by themselves or by their caregiver

Diagnostic Test: Standard of Care COVID-19 swab
All participants will receive a standard of care COVID-19 swab collected by a qualified healthcare professional

Outcome Measures

Primary Outcome Measures

  1. Buccal Swab Clinical Sensitivity [3 month recruitment timeframe]

    The study will evaluate the clinical sensitivity of buccal swab testing using Abbott ID NOW COVID-19 to detect SARS-CoV-2 infection among children aged 0-<18.0 years old presenting to the emergency department with an indication for SARS-CoV-2 testing as compared to standard of care reference standard COVID-19 swab testing

Secondary Outcome Measures

  1. Accuracy of Testing Approach [3 month recruitment timeframe]

    The team will Identify factors which influence the accuracy of testing such as symptoms onset, duration of symptoms, age, past medical history, vaccination status etc.

  2. Feasibility and Acceptability of Buccal Swab Collection [3 month recruitment timeframe]

    The study will examine the feasibility and perception of self/caregiver buccal swab sample collection

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Age <18.0 years old

  2. Presenting to a participating emergency department

  3. Consented to undergo local standard of care SARS-CoV-2 test

  4. Able to read/speak English or French

Exclusion Criteria:
  1. Inability or unwillingness of individual or legal guardian/representative to give written informed consent or child to give assent.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stollery Children's Hospital Edmonton Alberta Canada
2 BC Children's Hospital Vancouver British Columbia Canada
3 The Children's Hospital of Winnipeg Winnipeg Manitoba Canada
4 Janeway Children's Health and Rehabilitation Centre Saint John's Newfoundland and Labrador Canada
5 IWK Health Centre Halifax Nova Scotia Canada
6 Children's Hospital of Eastern Ontario Hamilton Ontario Canada
7 McMaster Children's Hospital Hamilton Ontario Canada
8 Kingston Health Sciences Centre Kingston Ontario Canada
9 Children's Hospital London Health Sciences Centre London Ontario Canada
10 The Hospital for Sick Children Toronto Ontario Canada
11 CHU Sainte-Justine Montréal Quebec Canada
12 Montreal Children's Hospital Montréal Quebec Canada
13 Centre Hospitalier de l'Universite de Laval Québec City Quebec Canada
14 Jim Pattison Children's Hospital Saskatoon Saskatchewan Canada

Sponsors and Collaborators

  • University of Calgary
  • Health Canada

Investigators

  • Principal Investigator: Stephen Freedman, MD, University of Calgary

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Calgary
ClinicalTrials.gov Identifier:
NCT05040763
Other Study ID Numbers:
  • REB21-1373
First Posted:
Sep 10, 2021
Last Update Posted:
Jul 22, 2022
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 22, 2022