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

Corona Virus Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05611203
• Other study ID #: H-22022937
• Status: Recruiting
• Phase: N/A
• Start date: November 10, 2022
• Est. completion date: March 2, 2023

Study information

• Verified date: January 2023
• Source: Rigshospitalet, Denmark
• Contact: Tobias Todsen, MD, PhD
• Phone: +45 35466008
• Email: tobias.todsen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 2, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Communicable Diseases
• Corona Virus Infection
• Coronavirus
• Coronavirus Infections
• Infections
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

Procedure:
• An Oropharyngeal swab
An Oropharyngeal swab performed for diagnostic purposes

Locations

Country	Name	City	State
Denmark	Hillerød Covid-19 Testcenter	Copenhagen	Hillerød
Denmark	Valby	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

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