Should Palatine Tonsils be Included in the Oropharyngeal Swab for SARS-CoV-2 Molecular Testing?
NCT ID: NCT05611203
Last Updated: 2023-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1000 participants
INTERVENTIONAL
2022-11-10
2023-03-02
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Oropharyngeal swab only including the posterior oropharyngeal wall
An Oropharyngeal swab is performed with the collection of specimens from the posterior oropharyngeal wall only
An Oropharyngeal swab
An Oropharyngeal swab performed for diagnostic purposes
Oropharyngeal swab including the posterior oropharyngeal wall and both palatine tonsils
An Oropharyngeal swab is performed with the collection of specimens from the posterior oropharyngeal wall and both palatine tonsils
An Oropharyngeal swab
An Oropharyngeal swab performed for diagnostic purposes
Interventions
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An Oropharyngeal swab
An Oropharyngeal swab performed for diagnostic purposes
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* neck breathers (tracheostomy/laryngectomy patients)
18 Years
ALL
Yes
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Tobias Todsen
Consultant, Associate Prof
Locations
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Hillerød Covid-19 Testcenter
Copenhagen, Hillerød, Denmark
Valby
Copenhagen, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Tobias Todsen, MD, PhD
Role: primary
Tobias Todsen, MD, PhD
Role: primary
References
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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.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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H-22022937
Identifier Type: -
Identifier Source: org_study_id
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