NCT04649424

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 2, 2020

Completed
20 days until next milestone

Study Start

First participant enrolled

December 22, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2021

Completed
Last Updated

July 15, 2021

Status Verified

July 1, 2021

Enrollment Period

4 months

First QC Date

November 27, 2020

Last Update Submit

July 14, 2021

Conditions

Covid19

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

CanSwab - 1st

EXPERIMENTAL

CanSwab will be swabbed first

Device: CanSwab

CanSwab - 2nd

EXPERIMENTAL

CanSwab will be swabbed second.

Device: CanSwab

Interventions

CanSwabDEVICE

New nasopharyngeal swab design.

CanSwab - 1stCanSwab - 2nd

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Malformation of the base of the known skull
  • Active nosebleed before the start of the sample

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Health Sciences Centre

Winnipeg, Manitoba, R3E 0Z3, Canada

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Anand Kumar, MD

    Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2020

First Posted

December 2, 2020

Study Start

December 22, 2020

Primary Completion

April 13, 2021

Study Completion

April 13, 2021

Last Updated

July 15, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)