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

Rigshospitalet

Status: Enrolling

Conditions: Corona Virus Infection; SARS-CoV Infection; Coronavirus

Treatments: Procedure: An Oropharyngeal swab

Study type: Interventional

Funder types: Other

Identifiers

NCT05611203

H-22022937

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

Oropharyngeal swab only including the posterior oropharyngeal wall

Experimental group

Description:

An Oropharyngeal swab is performed with the collection of specimens from the posterior oropharyngeal wall only

Treatment:

Procedure: An Oropharyngeal swab

Oropharyngeal swab including the posterior oropharyngeal wall and both palatine tonsils

Experimental group

Description:

An Oropharyngeal swab is performed with the collection of specimens from the posterior oropharyngeal wall and both palatine tonsils

Treatment:

Procedure: An Oropharyngeal swab