Back to resultsCOVID-19 Nasal Swab Trial
Primary Purpose
Covid19
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CanSwab
Sponsored by
About this trial
This is an interventional other trial for Covid19
Eligibility Criteria
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
Sites / Locations
- St. Boniface General Hospital
- Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
CanSwab - 1st
CanSwab - 2nd
Arm Description
CanSwab will be swabbed first
CanSwab will be swabbed second.
Outcomes
Primary Outcome Measures
Amount of SARS-CoV2 virus (COVID-19) collected
amount of SARS-CoV2 virus (COVID-19) collected measured in CT (thermal cycles).
Clinical concordance rate
Calculate approximate sensitivity and specificity of the CanSwab to the Flocked swab control.
Patient comfort
Patient description of comfort level between the 2 swabs experience measured by "Worse", "Identical" or "Better"
Secondary Outcome Measures
Full Information
NCT ID
NCT04649424
First Posted
November 27, 2020
Last Updated
July 14, 2021
Sponsor
Orthopaedic Innovation Centre
1. Study Identification
Unique Protocol Identification Number
NCT04649424
Brief Title
COVID-19 Nasal Swab Trial
Official Title
Comparative Evaluation of Nasopharyngeal Swabs for Sampling and Detection of SARS-CoV2
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
December 22, 2020 (Actual)
Primary Completion Date
April 13, 2021 (Actual)
Study Completion Date
April 13, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orthopaedic Innovation Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
The amount of SARS-CoV2 virus (COVID-19) collected by swabs, measured in CT (thermal cycles)
Clinical concordance rate
Patient comfort during nasopharyngeal sampling procedure
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
169 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CanSwab - 1st
Arm Type
Experimental
Arm Description
CanSwab will be swabbed first
Arm Title
CanSwab - 2nd
Arm Type
Experimental
Arm Description
CanSwab will be swabbed second.
Intervention Type
Device
Intervention Name(s)
CanSwab
Intervention Description
New nasopharyngeal swab design.
Primary Outcome Measure Information:
Title
Amount of SARS-CoV2 virus (COVID-19) collected
Description
amount of SARS-CoV2 virus (COVID-19) collected measured in CT (thermal cycles).
Time Frame
Baseline
Title
Clinical concordance rate
Description
Calculate approximate sensitivity and specificity of the CanSwab to the Flocked swab control.
Time Frame
Baseline
Title
Patient comfort
Description
Patient description of comfort level between the 2 swabs experience measured by "Worse", "Identical" or "Better"
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anand Kumar, MD
Organizational Affiliation
Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Boniface General Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0Z3
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
COVID-19 Nasal Swab Trial
We'll reach out to this number within 24 hrs