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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Corona Virus Infection; SARS-CoV Infection; Coronavirus
• Intervention / Treatment: Procedure: An Oropharyngeal swab

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

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tobias Todsen, MD, PhD; Phone Number: +45 35466008; Email: tobias.todsen@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2500
    • Recruiting
    • Valby
  • Hillerød
    • Copenhagen, Hillerød, Denmark, 3400
      • Recruiting
      • Hillerød Covid-19 Testcenter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oropharyngeal swab only including the posterior oropharyngeal wall; An Oropharyngeal swab is performed with the collection of specimens from the posterior oropharyngeal wall only	Procedure: An Oropharyngeal swab; An Oropharyngeal swab performed for diagnostic purposes
Experimental: 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	Procedure: An Oropharyngeal swab; An Oropharyngeal swab performed for diagnostic purposes

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2022
• Primary Completion (Anticipated): January 30, 2023
• Study Completion (Anticipated): March 2, 2023

Study Registration Dates

• First Submitted: November 3, 2022
• First Submitted That Met QC Criteria: November 8, 2022
• First Posted (Actual): November 9, 2022

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Disease Attributes; Severe Acute Respiratory Syndrome; Coronavirus Infections; Infections; Communicable Diseases
• Other Study ID Numbers: H-22022937

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Not decided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No