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

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Recruiting
CT.gov ID
NCT05611203
Collaborator
(none)
1,000
Enrollment
2
Locations
2
Arms
3.7
Anticipated Duration (Months)
500
Patients Per Site
135.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: An Oropharyngeal swab
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Actual Study Start Date :
Nov 10, 2022
Anticipated Primary Completion Date :
Jan 30, 2023
Anticipated Study Completion Date :
Mar 2, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. RT-PCR results [Day 1]

    The detection rate of SARS-CoV-2 RNA

Secondary Outcome Measures

  1. Sycle threshold (Ct) [Day 1]

    SARS-CoV-2 RT-PCR cycle threshold (Ct) values

  2. Inconclusive tests [Day 1]

    Number of inconclusive RT-PCR tests results

  3. Test discomfort [Day 1]

    Self reported on a 11-point NRS-scale from 0 - 10 (with 10 being the worst imaginable discomfort)

  4. Development of COVID-19 disease after testing [1 month]

    Online questionare about symptoms send by email

  5. Test accuracy between healthcare workers [Day 1]

    SARS-CoV-2 detection rate for each healthcare worker

  6. Participants oropharynx anatomy [Day 1]

    Mallampati Score of participants

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hillerød Covid-19 Testcenter Copenhagen Hillerød Denmark 3400
2 Valby Copenhagen Denmark 2500

Sponsors and Collaborators

  • Rigshospitalet, Denmark

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Tobias Todsen, Consultant, Associate Prof, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT05611203
Other Study ID Numbers:
  • H-22022937
First Posted:
Nov 9, 2022
Last Update Posted:
Jan 11, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Infections
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome

Study Results

No Results Posted as of Jan 11, 2023