MedDataX Logo

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

NCT ID: NCT04715607

Last Updated: 2021-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27947 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-22

Study Completion Date

2021-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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%.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

SARS-CoV Infection Covid19 Coronavirus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

Sequence of testing.

Intervention Type DIAGNOSTIC_TEST

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.

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

Group Type ACTIVE_COMPARATOR

Sequence of testing.

Intervention Type DIAGNOSTIC_TEST

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.

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

Group Type ACTIVE_COMPARATOR

Sequence of testing.

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hvidovre University Hospital

OTHER

Sponsor Role collaborator

Region Hovedstadens Apotek

OTHER_GOV

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tobias Todsen

MD, PhD, Assistant professor Tobias Todsen

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tobias Todsen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Rigshospitalet

Nikolai Kirkby, MD, PhD

Role: STUDY_DIRECTOR

Department of Clinical Microbiology, Rigshospitalet

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Valby COVID-19 teststed

Copenhagen, Valby, Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

References

Explore related publications, articles, or registry entries linked to this study.

Todsen T, Tolsgaard MG, Benfield T, Folke F, Jakobsen KK, Gredal NT, Ersboll AK, von Buchwald C, Kirkby N. Higher SARS-CoV-2 detection of oropharyngeal compared with nasopharyngeal or saliva specimen for molecular testing: a multicentre randomised comparative accuracy study. Thorax. 2023 Oct;78(10):1028-1034. doi: 10.1136/thorax-2022-219599. Epub 2023 May 19.

Reference Type DERIVED
PMID: 37208187 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33832565 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021-01

Identifier Type: -

Identifier Source: org_study_id