Clinical trial NCT05611203: Should Palatine Tonsils be Included in the Oropharyngeal Swab for SARS-CoV-2 Molecular Testing?
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: SARS-CoV Infection
Coronavirus
Corona Virus Infection
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2022-11-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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. 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

Eligibility criteria: 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)

Primary outcomes:
measure: RT-PCR results
timeFrame: Day 1
Secondary outcomes:
measure: Sycle threshold (Ct)
timeFrame: Day 1
measure: Inconclusive tests
timeFrame: Day 1
measure: Test discomfort
timeFrame: Day 1
measure: Development of COVID-19 disease after testing
timeFrame: 1 month
measure: Test accuracy between healthcare workers
timeFrame: Day 1
measure: Participants oropharynx anatomy
timeFrame: Day 1
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Hillerød Covid-19 Testcenter
state: Hillerød
city: Copenhagen
country: Denmark
facility: Valby
Study officials:
References: