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OpenTrials
Completed

NCT Number: NCT04649424

COVID-19 Nasal Swab Trial

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Sciences Centre, Winnipeg, Manitoba, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CanSwab

Device

New nasopharyngeal swab design.

Primary outcomes

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

    Time frame: Baseline

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

  2. Clinical concordance rate

    Time frame: Baseline

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

  3. Patient comfort

    Time frame: Baseline

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

Sponsors and collaborators

Lead sponsor

Orthopaedic Innovation Centre

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 2, 2020
Registry last updated
Jul 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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