Covid19NCT04840082
Optimal Length for Nasal Mid-turbinate and Nasopharyngeal Swabs
A study testing Nasopharyngeal swab for COVID-19 testing in people with Covid19, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
This study aim to explore the optimal swap insertion length for mid-turbinate and nasopharyngeal samples. Our clinical trial took place at a Covid-19 test center in Copenhagen. Participants consisted of voluntary citizens who were at the test center for a nasopharyngeal antigen quicktest. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Nasopharyngeal swab for COVID-19 testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Mar 2021to 8 Mar 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Referred for COVID-19 testing
Who cannot join
- Nose patology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimal Insertion Length for Nasal Mid-turbinate and Nasopharyngeal Swabs for Respiratory Virus Infection Diagnostic Testing - a Clinical Trial
This study aim to explore the optimal swap insertion length for mid-turbinate and nasopharyngeal samples. Our clinical trial took place at a Covid-19 test center in Copenhagen. Participants consisted of voluntary citizens who were at the test center for a nasopharyngeal antigen quicktest. An endoscopic examination was performed simultaneous with the swap to measure the length from the vestibulum nasi to the posterior wall of the nasopharynx and the mid-turbinate.
- Conditions
- Covid19
- Being tested
- Nasopharyngeal swab for COVID-19 testing
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasopharyngeal swab for COVID-19 testingDiagnostic test
A nasopharyngeal swab was performed endoscopically video guided to measure the actual length from to the mid turbinate and the posterior nasopharyngeal wall
| Study group | Role | What they receive |
|---|---|---|
| Collecting of Clinical Specimens for COVID-19 Testing | Experimental | Nasopharyngeal swab is performed on all participants to collect specimens for Rapid antigen COVID-19 Testing Receives: Diagnostic Test: Nasopharyngeal swab for COVID-19 testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length from the vestibulum nasi to the posterior wall of the nasopharynx.
Endoscopic measurement of the length from the vestibulum nasi to the posterior wall of the nasopharynx.
Measured: From inclusion at the testcenter until the COVID-19 testing was completed.
Length from the vestibulum nasi to the mid-turbinate.
Endoscopic measurement of the length from the vestibulum nasi to the mid-turbinate.
Measured: From inclusion at the testcenter until the endoscopic examination was completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start7 Mar 2021
- Primary completion8 Mar 2021
- Study completion8 Mar 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.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tobias Todsen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840082
- Sponsor's protocol ID
- 21015626
- Status last verified
- Apr 2021
- First submitted
- 6 Apr 2021
- Last updated
- 9 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Insertion Length for Nasal Mid-turbinate and Nasopharyngeal Swabs for Respiratory Virus Infection Diagnostic Testing - a Clinical Trial
- ClinicalTrials.gov ID
- NCT04840082
- Acronym / sponsor ID
- 21015626
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 7 Mar 2021 (actual)
- Primary completion
- 8 Mar 2021 (actual)
- Study completion
- 8 Mar 2021 (actual)
- First posted
- 9 Apr 2021 (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.
This study aim to explore the optimal swap insertion length for mid-turbinate and nasopharyngeal samples. Our clinical trial took place at a Covid-19 test center in Copenhagen. Participants consisted of voluntary citizens who were at the test center for a nasopharyngeal antigen quicktest. An endoscopic examination was performed simultaneous with the swap to measure the length from the vestibulum nasi to the posterior wall of the nasopharynx and the mid-turbinate.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Collecting of Clinical Specimens for COVID-19 Testing | Experimental | Diagnostic Test: Nasopharyngeal swab for COVID-19 testingNasopharyngeal swab is performed on all participants to collect specimens for Rapid antigen COVID-19 Testing |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Referred for COVID-19 testing
Key exclusion criteria (1 listed)
- Nose patology
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 |
|---|---|---|
| Nasopharyngeal swab for COVID-19 testingA nasopharyngeal swab was performed endoscopically video guided to measure the actual length from to the mid turbinate and the posterior nasopharyngeal wall | Diagnostic test | Collecting of Clinical Specimens for COVID-19 Testing |
Primary outcome
Length from the vestibulum nasi to the posterior wall of the nasopharynx.
Time frame: From inclusion at the testcenter until the COVID-19 testing was completed.
Endoscopic measurement of the length from the vestibulum nasi to the posterior wall of the nasopharynx.
Length from the vestibulum nasi to the mid-turbinate.
Time frame: From inclusion at the testcenter until the endoscopic examination was completed
Endoscopic measurement of the length from the vestibulum nasi to the mid-turbinate.
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 9 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasopharyngeal swab for COVID-19 testing in people with Covid19, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 1 inclusion and 1 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 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Length from the vestibulum nasi to the posterior wall of the nasopharynx. (time frame: From inclusion at the testcenter until the COVID-19 testing was completed.). The study lists 2 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 9 Apr 2021.