Coronavirus, Corona Virus Infection, SARS-CoV Infection
Conditions
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.
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
Interventions
PROCEDUREAn Oropharyngeal swab
An Oropharyngeal swab performed for diagnostic purposes
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RT-PCR results | Day 1 | The detection rate of SARS-CoV-2 RNA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inconclusive tests | Day 1 | Number of inconclusive RT-PCR tests results |
| Test discomfort | Day 1 | Self reported on a 11-point NRS-scale from 0 - 10 (with 10 being the worst imaginable discomfort) |
| Sycle threshold (Ct) | Day 1 | SARS-CoV-2 RT-PCR cycle threshold (Ct) values |
| Test accuracy between healthcare workers | Day 1 | SARS-CoV-2 detection rate for each healthcare worker |
| Participants oropharynx anatomy | Day 1 | Mallampati Score of participants |
| Development of COVID-19 disease after testing | 1 month | Online questionare about symptoms send by email |
Countries
Denmark
Contacts
Primary ContactTobias Todsen, MD, PhD
Outcome results
None listed