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PERC Health Canada COVID-19

NCT05040763 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7263

Last updated 2024-05-23

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Health Canada

    collaborator OTHER_GOV

  • University of Calgary

    lead OTHER

Principal Investigators

  • Stephen Freedman, MD · University of Calgary

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-10
Primary Completion
2022-09-30
Completion
2023-03-31

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05040763 on ClinicalTrials.gov