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Clinical Trials/NCT04649424
NCT04649424
Completed
Not Applicable

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

Orthopaedic Innovation Centre2 sites in 1 country169 target enrollmentDecember 22, 2020
ConditionsCovid19

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Covid19
Sponsor
Orthopaedic Innovation Centre
Enrollment
169
Locations
2
Primary Endpoint
Amount of SARS-CoV2 virus (COVID-19) collected
Status
Completed
Last Updated
4 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
December 22, 2020
End Date
April 13, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Orthopaedic Innovation Centre
Responsible Party
Sponsor

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Amount of SARS-CoV2 virus (COVID-19) collected

Time Frame: Baseline

amount of SARS-CoV2 virus (COVID-19) collected measured in CT (thermal cycles).

Clinical concordance rate

Time Frame: Baseline

Calculate approximate sensitivity and specificity of the CanSwab to the Flocked swab control.

Patient comfort

Time Frame: Baseline

Patient description of comfort level between the 2 swabs experience measured by "Worse", "Identical" or "Better"

Study Sites (2)

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