COVID-19: SARS-CoV-2 Detection in Saliva, Oropharyngeal and Nasopharyngeal Specimens

Covid19 Clinical Trial

Official title:

Comparison of Detection Rate of SARS-CoV-2 in Saliva, Oropharyngeal and Nasopharyngeal Specimens in a Public COVID-19 Test Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04715607
• Other study ID #: 2021-01
• Status: Completed
• Phase: N/A
• Start date: January 22, 2021
• Est. completion date: May 31, 2021

Study information

• Verified date: September 2021
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27947
• Est. completion date: May 31, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus
• COVID-19
• Covid19
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

Diagnostic Test:
• Sequence of testing.
The participants will be tested in the following sequences of sampling technique: (1) nasopharyngeal swab, oropharyngeal swab, and salvia collection OR (2) oropharyngeal swab, salvia collection, and nasopharyngeal swab OR (3) salvia collection, nasopharyngeal swab, and oropharyngeal swab. Only the sequence is different in the different arm, while the sampling technique for each method is the same in all arms.

Locations

Country	Name	City	State
Denmark	Valby COVID-19 teststed	Copenhagen	Valby

Sponsors (3)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Hvidovre University Hospital, Region Hovedstadens Apotek

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SARS-CoV-2 detection rates for oropharyngeal swabs (OPS) compared with nasopharyngeal swabs and saliva collection.	Due to the high specificity of RT-PCR, we will define a participant with an RT-PCR positive result from either Saliva, OPS or NPS as having a COVID-19 infection. The combined Saliva/OPS/NPS result will therefore be used as the diagnostic reference standard to calculate the sensitivity for the Saliva, OPS and NPS tests.	48 hours after testing
Secondary	SARS-CoV-2 RT-PCR cycle threshold (Ct) values	Ct values are compared between testing methods	48 hours after testing
Secondary	OPS, NPS and saliva test discomfort and likelihood to get retested	Discomfort scores (1-10) and likelihood to get retested are compared between testing methods	immediately after testing (10 minutes)
Secondary	Ratio of mutations in SARS-CoV-2	Detection rate of any mutations in SARS-CoV-2	48 hours after testing