Should Palatine Tonsils be Included in the Oropharyngeal Swab for SARS-CoV-2 Molecular Testing?

Study Overview
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Brief Summary
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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
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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

Official Title
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Molecular Detection of SARS-CoV-2 From Oropharyngeal Swabs Performed With or Without Specimen Collection From the Palatine Tonsils - a Multicenter Randomized Controlled Trial

Conditions
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Corona Virus Infection, SARS-CoV Infection, Coronavirus

Intervention / Treatment
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* Procedure: An Oropharyngeal swab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: citizens referred for outpatient testing for COVID-19 in Valby and Hillerød COVID-19 TestCenter. Exclusion Criteria: Age under 18 years neck breathers (tracheostomy/laryngectomy patients)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oropharyngeal swab only including the posterior oropharyngeal wall<br>An Oropharyngeal swab is performed with the collection of specimens from the posterior oropharyngeal wall only | Procedure: An Oropharyngeal swab<br>* An Oropharyngeal swab performed for diagnostic purposes<br>|
| Experimental: Oropharyngeal swab including the posterior oropharyngeal wall and both palatine tonsils<br>An Oropharyngeal swab is performed with the collection of specimens from the posterior oropharyngeal wall and both palatine tonsils | Procedure: An Oropharyngeal swab<br>* An Oropharyngeal swab performed for diagnostic purposes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RT-PCR results | The detection rate of SARS-CoV-2 RNA | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sycle threshold (Ct) | SARS-CoV-2 RT-PCR cycle threshold (Ct) values | Day 1 | 
| Inconclusive tests | Number of inconclusive RT-PCR tests results | Day 1 | 
| Test discomfort | Self reported on a 11-point NRS-scale from 0 - 10 (with 10 being the worst imaginable discomfort) | Day 1 | 
| Development of COVID-19 disease after testing | Online questionare about symptoms send by email | 1 month | 
| Test accuracy between healthcare workers | SARS-CoV-2 detection rate for each healthcare worker | Day 1 | 
| Participants oropharynx anatomy | Mallampati Score of participants | Day 1 |