SARS-CoV InfectionNCT05611203
Should Palatine Tonsils be Included in the Oropharyngeal Swab for SARS-CoV-2 Molecular Testing?
A study testing An Oropharyngeal swab in people with SARS-CoV Infection and Coronavirus, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial summary
Citizens who undergo testing for COVID-19 at one of two Testcenters in Copenhagen Captial Region will be invited to participate in the study. The participants will be randomized to either an oropharyngeal swap including the palatine tonsils OR an oropharyngeal swap without the palatine tonsils for SARS-CoV-2 testing. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV Infection, Coronavirus, Corona Virus Infection
- What is being tested?
- An Oropharyngeal swab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 2 sitesDenmark
- Study dates
- 10 Nov 2022to 2 Mar 2023
- 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
- citizens referred for outpatient testing for COVID-19 in Valby and Hillerød COVID-19 TestCenter.
Who cannot join
- Age under 18 years
- neck breathers (tracheostomy/laryngectomy patients)
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Recruiting
Hillerød Covid-19 Testcenter
Copenhagen, Hillerød, 3400
Tobias Todsen, MD, PhD
- Recruiting
Valby
Copenhagen, 2500
Tobias Todsen, MD, PhD
About this study
Official title: Molecular Detection of SARS-CoV-2 From Oropharyngeal Swabs Performed With or Without Specimen Collection From the Palatine Tonsils - a Multicenter Randomized Controlled Trial
Citizens who undergo testing for COVID-19 at one of two Testcenters in Copenhagen Captial Region will be invited to participate in the study. The participants will be randomized to either an oropharyngeal swap including the palatine tonsils OR an oropharyngeal swap without the palatine tonsils for SARS-CoV-2 testing. The swabs will be sent to the clinical microbiology laboratory for SARS-CoV-2 detection using RT-PCR. The diagnostic accuracy and SARS-CoV-2 viral load will be compared. The participants will be asked to complete a questionnaire regarding their symptoms.
Read the detailed description
We will include citizens referred for outpatient testing for COVID-19 who will be offered to participante in the study on a volunteer basis. Participants are all volunteers, who are attending the test facilities to obtain a PCR test. Participants are required to provide oral and written informed consent to participate before entering the study. The inclusion criterion is 18 years or more of age. Exclusion criteria are neck breathers (tracheostomy/laryngectomy patients).
The participants will be randomized to either an oropharyngeal swap including the palatine tonsils OR an oropharyngeal swap without the palatine tonsils for SARS-CoV-2 testing.
The swabs will be sent to the clinical microbiology laboratory for SARS-CoV-2 detection using RT-PCR as usual. The diagnostic accuracy and SARS-CoV-2 viral load will be compared using independent t-test. The participants will be asked to complete a questionnaire regarding their symptoms and the number of sick days. All data will be documented on-site in a secure web database (REDCap).
The primary outcome will be reported as:
- SARS-CoV-2 RNA by RT-PCR test result (positive, negative, inconclusive)
The secondary outcome will be reported as:
- SARS-CoV-2 RT-PCR cycle threshold (Ct) value
- Test discomfort on a 11-point NRS-scale
- Development of COVID-19 disease after testing
- SARS-CoV-2 detection rate for each healthcare worker
- Mallampati Score of participants being tested
- Conditions
- SARS-CoV Infection, Coronavirus, Corona Virus Infection
- Being tested
- An Oropharyngeal swab
- Medical subject headings
- Severe Acute Respiratory Syndrome, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An Oropharyngeal swabProcedure or surgery
An Oropharyngeal swab performed for diagnostic purposes
| Study group | Role | What they receive |
|---|---|---|
| Oropharyngeal swab only including the posterior oropharyngeal wall | Experimental | An Oropharyngeal swab is performed with the collection of specimens from the posterior oropharyngeal wall only Receives: Procedure: An Oropharyngeal swab |
| Oropharyngeal swab including the posterior oropharyngeal wall and both palatine tonsils | Experimental | An Oropharyngeal swab is performed with the collection of specimens from the posterior oropharyngeal wall and both palatine tonsils Receives: Procedure: An Oropharyngeal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
RT-PCR results
The detection rate of SARS-CoV-2 RNA
Measured: Day 1
Secondary outcomes (6)
Sycle threshold (Ct)
SARS-CoV-2 RT-PCR cycle threshold (Ct) values
Measured: Day 1
Inconclusive tests
Number of inconclusive RT-PCR tests results
Measured: Day 1
Test discomfort
Self reported on a 11-point NRS-scale from 0 - 10 (with 10 being the worst imaginable discomfort)
Measured: Day 1
Development of COVID-19 disease after testing
Online questionare about symptoms send by email
Measured: 1 month
Test accuracy between healthcare workers
SARS-CoV-2 detection rate for each healthcare worker
Measured: Day 1
Participants oropharynx anatomy
Mallampati Score of participants
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start10 Nov 2022
- Primary completion30 Jan 2023 (estimated)
- Study completion2 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV InfectionStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
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
- NCT05611203
- Sponsor's protocol ID
- H-22022937
- Status last verified
- Jan 2023
- First submitted
- 3 Nov 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not decided
Publications
Hartvigsen B, Jakobsen KK, Benfield T, Gredal NT, Ersboll AK, Gronlund MW, Bundgaard H, Andersen MP, Steenhard N, von Buchwald C, Todsen T. Molecular Detection of SARS-CoV-2 From Throat Swabs Performed With or Without Specimen Collection From the Tonsils: Protocol for a Multicenter Randomized Controlled Trial. JMIR Res Protoc. 2024 Jun 12;13:e47446. doi: 10.2196/47446.
PubMed 38865190
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Detection of SARS-CoV-2 From Oropharyngeal Swabs Performed With or Without Specimen Collection From the Palatine Tonsils - a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05611203
- Acronym / sponsor ID
- H-22022937
- Conditions
- SARS-CoV Infection, Coronavirus, Corona Virus Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 30 Jan 2023 (estimated)
- Study completion
- 2 Mar 2023 (estimated)
- First posted
- 9 Nov 2022 (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.
Citizens who undergo testing for COVID-19 at one of two Testcenters in Copenhagen Captial Region will be invited to participate in the study. The participants will be randomized to either an oropharyngeal swap including the palatine tonsils OR an oropharyngeal swap without the palatine tonsils for SARS-CoV-2 testing. The swabs will be sent to the clinical microbiology laboratory for SARS-CoV-2 detection using RT-PCR. The diagnostic accuracy and SARS-CoV-2 viral load will be compared. The participants will be asked to complete a questionnaire regarding their symptoms.
Detailed description
We will include citizens referred for outpatient testing for COVID-19 who will be offered to participante in the study on a volunteer basis. Participants are all volunteers, who are attending the test facilities to obtain a PCR test. Participants are required to provide oral and written informed consent to participate before entering the study. The inclusion criterion is 18 years or more of age. Exclusion criteria are neck breathers (tracheostomy/laryngectomy patients).
The participants will be randomized to either an oropharyngeal swap including the palatine tonsils OR an oropharyngeal swap without the palatine tonsils for SARS-CoV-2 testing.
The swabs will be sent to the clinical microbiology laboratory for SARS-CoV-2 detection using RT-PCR as usual. The diagnostic accuracy and SARS-CoV-2 viral load will be compared using independent t-test. The participants will be asked to complete a questionnaire regarding their symptoms and the number of sick days. All data will be documented on-site in a secure web database (REDCap).
The primary outcome will be reported as:
- SARS-CoV-2 RNA by RT-PCR test result (positive, negative, inconclusive)
The secondary outcome will be reported as:
- SARS-CoV-2 RT-PCR cycle threshold (Ct) value
- Test discomfort on a 11-point NRS-scale
- Development of COVID-19 disease after testing
- SARS-CoV-2 detection rate for each healthcare worker
- Mallampati Score of participants being tested
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oropharyngeal swab only including the posterior oropharyngeal wall | Experimental | Procedure: An Oropharyngeal swabAn Oropharyngeal swab is performed with the collection of specimens from the posterior oropharyngeal wall only |
| Oropharyngeal swab including the posterior oropharyngeal wall and both palatine tonsils | Experimental | Procedure: An Oropharyngeal swabAn Oropharyngeal swab is performed with the collection of specimens from the posterior oropharyngeal wall and both palatine tonsils |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- citizens referred for outpatient testing for COVID-19 in Valby and Hillerød COVID-19 TestCenter.
Key exclusion criteria (2 listed)
- Age under 18 years
- neck breathers (tracheostomy/laryngectomy patients)
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 |
|---|---|---|
| An Oropharyngeal swabAn Oropharyngeal swab performed for diagnostic purposes | Procedure or surgery | Oropharyngeal swab including the posterior oropharyngeal wall and both palatine tonsils, Oropharyngeal swab only including the posterior oropharyngeal wall |
Primary outcome
RT-PCR results
Time frame: Day 1
The detection rate of SARS-CoV-2 RNA
6 secondary outcomes
Sycle threshold (Ct)
Time frame: Day 1
Inconclusive tests
Time frame: Day 1
Test discomfort
Time frame: Day 1
Development of COVID-19 disease after testing
Time frame: 1 month
Test accuracy between healthcare workers
Time frame: Day 1
Participants oropharynx anatomy
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Derived from this study: PubMed 38865190Hartvigsen B, Jakobsen KK, Benfield T, Gredal NT, Ersboll AK, Gronlund MW, Bundgaard H, Andersen MP, Steenhard N, von Buchwald C, Todsen T. Molecular Detection of SARS-CoV-2 From Throat Swabs Performed With or Without Specimen Collection From the Tonsils: Protocol for a Multicenter Randomized Controlled Trial. JMIR Res Protoc. 2024 Jun 12;13:e47446. doi: 10.2196/47446.
- Individual participant dataSharing planned: Undecided. Not decided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing An Oropharyngeal swab in people with SARS-CoV Infection and Coronavirus, run by Copenhagen University Hospital, Rigshospitalet at 2 sites 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 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: status not confirmed, as of the sponsor's last update on 11 Jan 2023. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tobias Todsen, MD, PhD (+45 35466008, tobias.todsen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RT-PCR results (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05611203, which also lists 1 linked publication.
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 11 Jan 2023.