COVID-19 Nasal Swab Trial

Not Applicable

Completed

• Conditions: Covid19
• Interventions: Device: CanSwab

• Registration Number: NCT04649424
• Lead Sponsor: Orthopaedic Innovation Centre

Brief Summary

The purpose of this trial is to compare 2 types of nasonasopharyngeal swabs (a new design to a conventional nylon-flocked nasopharyngeal swab) for effectiveness.

Detailed Description

Compare the Precision ADM "CanSwab" nasopharyngeal swab to a conventional nylon-flocked nasopharyngeal swab on the basis of:

1. The amount of SARS-CoV2 virus (COVID-19) collected by swabs, measured in CT (thermal cycles)

2. Clinical concordance rate

3. Patient comfort during nasopharyngeal sampling procedure

Study Timeline

• Study First Submitted: 2020-11-27
• Study First Submitted QC: 2020-11-30
• Study First Posted: 2020-12-02
• Study Start: 2020-12-22
• Primary Completion: 2021-04-13
• Study Completion: 2021-04-13
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-14
• Last Update Posted: 2021-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

Inclusion Criteria

• 18 years and older
• Ability to provide informed consent
• COVID-19 positive cohort only: a previous, positive COVID-19 test in the last 5 days and patient remains symptomatic

Exclusion criteria:

• Malformation of the base of the known skull
• Active nosebleed before the start of the sample

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CanSwab - 2nd	CanSwab	CanSwab will be swabbed second.
CanSwab - 1st	CanSwab	CanSwab will be swabbed first

Primary Outcome Measures

Name	Time	Method
Amount of SARS-CoV2 virus (COVID-19) collected	Baseline	amount of SARS-CoV2 virus (COVID-19) collected measured in CT (thermal cycles).
Clinical concordance rate	Baseline	Calculate approximate sensitivity and specificity of the CanSwab to the Flocked swab control.
Patient comfort	Baseline	Patient description of comfort level between the 2 swabs experience measured by "Worse", "Identical" or "Better"

Trial Locations

Locations (2)

St. Boniface General Hospital; 🇨🇦 Winnipeg, Manitoba, Canada

Health Sciences Centre; 🇨🇦 Winnipeg, Manitoba, Canada