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

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT04715607
Collaborator
Hvidovre University Hospital (Other), Region Hovedstadens Apotek (Other)
27,947
1
3
4.2
6594.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Sequence of testing.
N/A

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%.

Study Design

Study Type:
Interventional
Actual Enrollment :
27947 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
Comparison of Detection Rate of SARS-CoV-2 in Saliva, Oropharyngeal and Nasopharyngeal Specimens in a Public COVID-19 Test Setting
Actual Study Start Date :
Jan 22, 2021
Actual Primary Completion Date :
May 30, 2021
Actual Study Completion Date :
May 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Nasopharyngeal swab, oropharyngeal swab, and salvia collection

The participants will first be tested with nasopharyngeal swabs followed by oropharyngeal swab and saliva collection. The collection material, virus transport medium and laboratory equipment for each method is the same in both arms

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.

Active Comparator: Oropharyngeal swab, salvia collection, and nasopharyngeal swab

The participants will first be tested with oropharyngeal swabs followed by saliva collection and nasopharyngeal swab. The collection material, virus transport medium and laboratory equipment for each method is the same in both arms

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.

Active Comparator: Salvia collection, nasopharyngeal swab, and oropharyngeal swab

The participants will first be tested with saliva collection followed by nasopharyngeal swab and oropharyngeal swabs. The collection material, virus transport medium and laboratory equipment for each method is the same in both arms

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.

Outcome Measures

Primary Outcome Measures

  1. SARS-CoV-2 detection rates for oropharyngeal swabs (OPS) compared with nasopharyngeal swabs and saliva collection. [48 hours after testing]

    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.

Secondary Outcome Measures

  1. SARS-CoV-2 RT-PCR cycle threshold (Ct) values [48 hours after testing]

    Ct values are compared between testing methods

  2. OPS, NPS and saliva test discomfort and likelihood to get retested [immediately after testing (10 minutes)]

    Discomfort scores (1-10) and likelihood to get retested are compared between testing methods

  3. Ratio of mutations in SARS-CoV-2 [48 hours after testing]

    Detection rate of any mutations in SARS-CoV-2

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Valby COVID-19 teststed Copenhagen Valby Denmark 2500

Sponsors and Collaborators

  • Rigshospitalet, Denmark
  • Hvidovre University Hospital
  • Region Hovedstadens Apotek

Investigators

  • Principal Investigator: Tobias Todsen, MD, PhD, Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Rigshospitalet
  • Study Director: Nikolai Kirkby, MD, PhD, Department of Clinical Microbiology, Rigshospitalet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tobias Todsen, MD, PhD, Assistant professor Tobias Todsen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT04715607
Other Study ID Numbers:
  • 2021-01
First Posted:
Jan 20, 2021
Last Update Posted:
Sep 30, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 30, 2021