Clinical trial NCT04715607: COVID-19: SARS-CoV-2 Detection in Saliva, Oropharyngeal and Nasopharyngeal Specimens
Official title: Comparison of Detection Rate of SARS-CoV-2 in Saliva, Oropharyngeal and Nasopharyngeal Specimens in a Public COVID-19 Test Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SARS-CoV Infection
Covid19
Coronavirus
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Hvidovre University Hospital
name: Region Hovedstadens Apotek
First posted: 2021-01-20
Enrollment: 27947
Sex: ALL
Minimum age (years): 16
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants will have Saliva collected and recieve nasopharyngeal swabs and oropharyngeal swabs for SARS-COV2. To avoid systematic bias we plan to randomize the sequence of testing.
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to compare the SARS-CoV-2 detection rate using either a Saliva, oropharyngeal swabs or nasopharyngeal swab method for specimen collection.

Detailed description: The reference test to evaluate patients with suspected respiratory infection caused by virus is a real-time reverse transcription-polymerase chain reaction (RT-PCR) from a nasopharyngeal swab (NPS). However, other specimen collection methods like oropharyngeal swabs (OPS) and a saliva specimen collection have also been accepted by the Centers for Disease Control and Prevention for SARS-CoV-2 testing during the current coronavirus disease 19 (COVID-19) pandemic. It is unclear how much the SARS-CoV-2 detection rate differs when using different sampling methods and the aim of this study is to compare the expected COVID-19 detection rate using saliva, oropharyngeal swabs or nasopharyngeal swab in a public setting.

We, therefore, aim to investigate the detection rate of SARS-CoV-2 in Saliva, oropharyngeal swab, and nasopharyngeal swab specimen samples collected in symptomatic and non-symptomatic individuals tested for COVID-19 in a public test center during the COVID-19 pandemic.

Individuals referred for outpatient COVID-19 testing center will be invited to participate in a prospective clinical study. They will have saliva, OPS, and NPS specimen collection performed at the same time and analyzed separately for SARS-CoV-2. The rate for SARS-CoV-2 detection in saliva, OPS, and NPS will be compared using a logistic regression mixed-effect analysis. A Sample Size Calculation estimated that a sample of 18,000 participants would be needed for the trial with 80% power at a significance level of 5%.

Eligibility criteria: Inclusion Criteria:

* volunteers, who are attending the COVID-19 test facilities to obtain a RT-PCR test.
* oral and written informed consent to participate before entering the study.

Exclusion Criteria:

* Failure to understand and provide informed consent.
* Neck breathers (tracheostomy/laryngectomy patients) or other nasopharyngeal or oropharyngeal anomalies that do not allow for sampling using swabs.

Primary outcomes:
measure: SARS-CoV-2 detection rates for oropharyngeal swabs (OPS) compared with nasopharyngeal swabs and saliva collection.
timeFrame: 48 hours after testing
Secondary outcomes:
measure: SARS-CoV-2 RT-PCR cycle threshold (Ct) values
timeFrame: 48 hours after testing
measure: OPS, NPS and saliva test discomfort and likelihood to get retested
timeFrame: immediately after testing (10 minutes)
measure: Ratio of mutations in SARS-CoV-2
timeFrame: 48 hours after testing
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Valby COVID-19 teststed
state: Valby
Study officials:
affiliation: Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Rigshospitalet
name: Tobias Todsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Clinical Microbiology, Rigshospitalet
name: Nikolai Kirkby, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Todsen T, Tolsgaard M, Folke F, Jakobsen KK, Ersboll AK, Benfield T, von Buchwald C, Kirkby N. SARS-CoV-2 in saliva, oropharyngeal and nasopharyngeal specimens. Dan Med J. 2021 Apr 7;68(5):A01210087.