COVID-19 Nasal Swab Trial

Comparative Evaluation of Nasopharyngeal Swabs for Sampling and Detection of SARS-CoV2

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Device: CanSwab

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 Type: Interventional
• Enrollment (Actual): 169
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • St. Boniface General Hospital
    • Winnipeg, Manitoba, Canada, R3E 0Z3
      • Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CanSwab - 1st; CanSwab will be swabbed first	Device: CanSwab; New nasopharyngeal swab design.
EXPERIMENTAL: CanSwab - 2nd; CanSwab will be swabbed second.	Device: CanSwab; New nasopharyngeal swab design.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Orthopaedic Innovation Centre
• Investigators: Principal Investigator: Anand Kumar, MD, Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 22, 2020
• Primary Completion (ACTUAL): April 13, 2021
• Study Completion (ACTUAL): April 13, 2021

Study Registration Dates

• First Submitted: November 27, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (ACTUAL): December 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 15, 2021
• Last Update Submitted That Met QC Criteria: July 14, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: B2020:121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No