COVID-19 Nasal Swab Trial

NCT ID: NCT04649424

Last Updated: 2021-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

169 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-22

Study Completion Date

2021-04-13

Brief Summary

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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

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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

Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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CanSwab - 1st

CanSwab will be swabbed first

Group Type EXPERIMENTAL

CanSwab

Intervention Type DEVICE

New nasopharyngeal swab design.

CanSwab - 2nd

CanSwab will be swabbed second.

Group Type EXPERIMENTAL

CanSwab

Intervention Type DEVICE

New nasopharyngeal swab design.

Interventions

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CanSwab

New nasopharyngeal swab design.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Orthopaedic Innovation Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anand Kumar, MD

Role: PRINCIPAL_INVESTIGATOR

Health Sciences Centre

Locations

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St. Boniface General Hospital

Winnipeg, Manitoba, Canada

Site Status

Health Sciences Centre

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

Other Identifiers

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B2020:121

Identifier Type: -

Identifier Source: org_study_id

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