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
Brief Summary

Citizens who undergo testing for COVID-19 at one of two Testcenters in Copenhagen CaptialRegion will be invited to participate in the study. The participants will be randomizedto either an oropharyngeal swap including the palatine tonsils OR an oropharyngeal swapwithout the palatine tonsils for SARS-CoV-2 testing. The swabs will be sent to theclinical microbiology laboratory for SARS-CoV-2 detection using RT-PCR. The diagnosticaccuracy and SARS-CoV-2 viral load will be compared. The participants will be asked tocomplete a questionnaire regarding their symptoms.

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

Unknown status
SARS-CoV Infection
Coronavirus
Corona Virus Infection

Procedure: An Oropharyngeal swab

An Oropharyngeal swab performed for diagnostic purposes

Eligibility Criteria

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)

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Denmark
Locations

Hillerød Covid-19 Testcenter
Copenhagen, Hillerød, Denmark

Valby
Copenhagen, Denmark

Contacts

Tobias Todsen, MD, PhD
+45 35466008
tobias.todsen@regionh.dk

Not Provided

Rigshospitalet, Denmark
NCT Number
MeSH Terms
Infections
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome