Should Palatine Tonsils be Included in the Oropharyngeal Swab for

Status Recruiting

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05611203
Study type	Interventional
Source	Rigshospitalet, Denmark
Contact	Tobias Todsen, MD, PhD
Phone	+45 35466008
Email	tobias.todsen@regionh.dk
Status	Recruiting
Phase	N/A
Start date	November 10, 2022
Completion date	March 2, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms