COVID-19 Nasal Swab Trial | NCT04649424

Studies
COVID-19 Nasal Swab Trial

NCT04649424

Sponsor

Orthopaedic Innovation Centre

Status

Completed

Last Update Posted

Jul 15, 2021Actual

Enrollment

169Actual

Phase

Not Applicable

Conditions

Covid19

Interventions

CanSwab

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 22, 2020Actual

Primary Completion Date

Apr 13, 2021Actual

Completion Date

Apr 13, 2021Actual

First Submitted Date

Nov 27, 2020

First Submission Date that Met QC Criteria

Nov 30, 2020

First Posted Date

Dec 2, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2021

Last Update Posted Date

Jul 15, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

169Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CanSwab - 1st	Experimental	CanSwab will be swabbed first	Device: CanSwab
CanSwab - 2nd	Experimental	CanSwab will be swabbed second.	Device: CanSwab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CanSwab	Device	New nasopharyngeal swab design.	CanSwab - 1st CanSwab - 2nd

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anand Kumar, MD	Health Sciences Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Boniface General Hospital		Winnipeg	Manitoba	R2H 2A6	Canada
Health Sciences Centre

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided