We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

PERC Health Canada COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05040763
Recruitment Status : Recruiting
First Posted : September 10, 2021
Last Update Posted : July 22, 2022
Sponsor:
Collaborator:
Health Canada
Information provided by (Responsible Party):
University of Calgary

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
COVID-19 SARS-CoV-2 Infection Diagnostic Test: Buccal Swabc- Copan flocked swab Diagnostic Test: Standard of Care COVID-19 swab Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 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 : November 10, 2021
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Buccal Swab Clinical Sensitivity [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 3 month recruitment timeframe ]
    The study will examine the feasibility and perception of self/caregiver buccal swab sample collection



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05040763


Contacts
Layout table for location contacts
Contact: Stephen Freedman, MD (403) 955-7740 Stephen.Freedman@albertahealthservices.ca
Contact: Kelly Kim (403) 955-7740 Kelly.Kim@albertahealthservices.ca

Locations
Layout table for location information
Canada, Alberta
Stollery Children's Hospital Recruiting
Edmonton, Alberta, Canada
Contact: Andrew Dixon         
Principal Investigator: Bruce Wright         
Sub-Investigator: Andrew Dixon         
Canada, British Columbia
BC Children's Hospital Recruiting
Vancouver, British Columbia, Canada
Contact: Quynh Doan         
Principal Investigator: Quynh Doan         
Canada, Manitoba
The Children's Hospital of Winnipeg Not yet recruiting
Winnipeg, Manitoba, Canada
Contact: Darcy Beer         
Principal Investigator: Darcy Beer         
Canada, Newfoundland and Labrador
Janeway Children's Health and Rehabilitation Centre Recruiting
Saint John's, Newfoundland and Labrador, Canada
Contact: Robert Porter         
Principal Investigator: Robert Porter         
Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada
Contact: Jason Emsley         
Principal Investigator: Jason Emsley         
Canada, Ontario
Children's Hospital of Eastern Ontario Recruiting
Hamilton, Ontario, Canada
Contact: Roger Zemek         
Principal Investigator: Roger Zemek         
Sub-Investigator: Maala Bhatt         
McMaster Children's Hospital Recruiting
Hamilton, Ontario, Canada
Contact: April Kam         
Principal Investigator: April Kam         
Kingston Health Sciences Centre Recruiting
Kingston, Ontario, Canada
Contact: Kirk Leifso         
Principal Investigator: Kirk Leifso         
Children's Hospital London Health Sciences Centre Recruiting
London, Ontario, Canada
Contact: Naveen Poonai         
Principal Investigator: Naveen Poonai         
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada
Contact: Gabrielle Freire         
Principal Investigator: Gabrielle Freire         
Canada, Quebec
CHU Sainte-Justine Recruiting
Montréal, Quebec, Canada
Contact: Jocelyn Gravel         
Principal Investigator: Jocelyn Gravel         
Montreal Children's Hospital Recruiting
Montréal, Quebec, Canada
Contact: Brett Burstein         
Principal Investigator: Brett Burstein         
Centre Hospitalier de l'Universite de Laval Recruiting
Québec City, Quebec, Canada
Contact: Simon Berthelot         
Principal Investigator: Simon Berthelot         
Canada, Saskatchewan
Jim Pattison Children's Hospital Recruiting
Saskatoon, Saskatchewan, Canada
Contact: Ahmed Mater         
Principal Investigator: Ahmed Mater         
Sponsors and Collaborators
University of Calgary
Health Canada
Investigators
Layout table for investigator information
Principal Investigator: Stephen Freedman, MD University of Calgary
Layout table for additonal information
Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT05040763    
Other Study ID Numbers: REB21-1373
First Posted: September 10, 2021    Key Record Dates
Last Update Posted: July 22, 2022
Last Verified: November 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases