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

January 10, 2023 updated by: Tobias Todsen, Rigshospitalet, Denmark

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional 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
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
Time Frame: Day 1
The detection rate of SARS-CoV-2 RNA
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sycle threshold (Ct)
Time Frame: Day 1
SARS-CoV-2 RT-PCR cycle threshold (Ct) values
Day 1
Inconclusive tests
Time Frame: Day 1
Number of inconclusive RT-PCR tests results
Day 1
Test discomfort
Time Frame: Day 1
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
Time Frame: 1 month
Online questionare about symptoms send by email
1 month
Test accuracy between healthcare workers
Time Frame: Day 1
SARS-CoV-2 detection rate for each healthcare worker
Day 1
Participants oropharynx anatomy
Time Frame: Day 1
Mallampati Score of participants
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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