Covid19NCT04649424
COVID-19 Nasal Swab Trial
A study testing CanSwab in people with Covid19, run by Orthopaedic Innovation Centre at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- CanSwab
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 2 sitesCanada
- Study dates
- 22 Dec 2020to 13 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Malformation of the base of the known skull
- Active nosebleed before the start of the sample
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
Health Sciences Centre
Winnipeg, Manitoba, R3E 0Z3
About this study
Official title: Comparative Evaluation of Nasopharyngeal Swabs for Sampling and Detection of SARS-CoV2
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.
Read the 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
- Conditions
- Covid19
- Being tested
- CanSwab
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CanSwabDevice
New nasopharyngeal swab design.
| Study group | Role | What they receive |
|---|---|---|
| CanSwab - 1st | Experimental | CanSwab will be swabbed first Receives: Device: CanSwab |
| CanSwab - 2nd | Experimental | CanSwab will be swabbed second. Receives: Device: CanSwab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of SARS-CoV2 virus (COVID-19) collected
amount of SARS-CoV2 virus (COVID-19) collected measured in CT (thermal cycles).
Measured: Baseline
Clinical concordance rate
Calculate approximate sensitivity and specificity of the CanSwab to the Flocked swab control.
Measured: Baseline
Patient comfort
Patient description of comfort level between the 2 swabs experience measured by "Worse", "Identical" or "Better"
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start22 Dec 2020
- Primary completion13 Apr 2021
- Study completion13 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthopaedic Innovation Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anand Kumar, MD, Principal investigator, Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649424
- Sponsor's protocol ID
- B2020:121
- Status last verified
- Jul 2021
- First submitted
- 27 Nov 2020
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Nasopharyngeal Swabs for Sampling and Detection of SARS-CoV2
- ClinicalTrials.gov ID
- NCT04649424
- Acronym / sponsor ID
- B2020:121
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Orthopaedic Innovation CentreUniversity, hospital or other
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- 13 Apr 2021 (actual)
- Study completion
- 13 Apr 2021 (actual)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CanSwab - 1st | Experimental | Device: CanSwabCanSwab will be swabbed first |
| CanSwab - 2nd | Experimental | Device: CanSwabCanSwab will be swabbed second. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Malformation of the base of the known skull
- Active nosebleed before the start of the sample
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CanSwabNew nasopharyngeal swab design. | Device | CanSwab - 1st, CanSwab - 2nd |
Primary outcome
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"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anand Kumar, MD principal investigator
Health Sciences Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CanSwab in people with Covid19, run by Orthopaedic Innovation Centre at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of SARS-CoV2 virus (COVID-19) collected (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.