SARS-CoV InfectionNCT04715607
COVID-19: SARS-CoV-2 Detection in Saliva, Oropharyngeal and Nasopharyngeal Specimens
A study testing Sequence of testing. in people with SARS-CoV Infection and Covid19, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 16 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV Infection, Covid19, Coronavirus
- What is being tested?
- Sequence of testing.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27,947 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Jan 2021to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 120 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Detection Rate of SARS-CoV-2 in Saliva, Oropharyngeal and Nasopharyngeal Specimens in a Public COVID-19 Test Setting
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.
Read the 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%.
- Conditions
- SARS-CoV Infection, Covid19, Coronavirus
- Being tested
- Sequence of testing.
- Medical subject headings
- Severe Acute Respiratory Syndrome, COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequence of testing.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.
| Study group | Role | What they receive |
|---|---|---|
| Nasopharyngeal swab, oropharyngeal swab, and salvia collection | Active comparator | 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 Receives: Diagnostic Test: Sequence of testing. |
| Oropharyngeal swab, salvia collection, and nasopharyngeal swab | Active comparator | 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 Receives: Diagnostic Test: Sequence of testing. |
| Salvia collection, nasopharyngeal swab, and oropharyngeal swab | Active comparator | 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 Receives: Diagnostic Test: Sequence of testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours after testing
Secondary outcomes (3)
SARS-CoV-2 RT-PCR cycle threshold (Ct) values
Ct values are compared between testing methods
Measured: 48 hours after testing
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
Measured: immediately after testing (10 minutes)
Ratio of mutations in SARS-CoV-2
Detection rate of any mutations in SARS-CoV-2
Measured: 48 hours after testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start22 Jan 2021
- Primary completion30 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV InfectionStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 27,947 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital, Region Hovedstadens Apotek
- Responsible party
- Principal investigator, Tobias Todsen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Tobias Todsen, MD, PhD, Principal investigator, Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, RigshospitaletNikolai Kirkby, MD, PhD, Study director, Department of Clinical Microbiology, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715607
- Sponsor's protocol ID
- 2021-01
- Status last verified
- Sep 2021
- First submitted
- 12 Jan 2021
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37208187Todsen 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.
PubMed 33832565
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Detection Rate of SARS-CoV-2 in Saliva, Oropharyngeal and Nasopharyngeal Specimens in a Public COVID-19 Test Setting
- ClinicalTrials.gov ID
- NCT04715607
- Acronym / sponsor ID
- 2021-01
- Conditions
- SARS-CoV Infection, Covid19, Coronavirus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27,947 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital, Region Hovedstadens Apotek
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Nasopharyngeal swab, oropharyngeal swab, and salvia collection | Active comparator | Diagnostic Test: Sequence of testing.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 |
| Oropharyngeal swab, salvia collection, and nasopharyngeal swab | Active comparator | Diagnostic Test: Sequence of testing.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 |
| Salvia collection, nasopharyngeal swab, and oropharyngeal swab | Active comparator | Diagnostic Test: Sequence of testing.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 |
Who may qualify
- Ages
- 16 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Nasopharyngeal swab, oropharyngeal swab, and salvia collection, Oropharyngeal swab, salvia collection, and nasopharyngeal swab, Salvia collection, nasopharyngeal swab, and oropharyngeal swab |
Primary outcome
SARS-CoV-2 detection rates for oropharyngeal swabs (OPS) compared with nasopharyngeal swabs and saliva collection.
Time frame: 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.
3 secondary outcomes
SARS-CoV-2 RT-PCR cycle threshold (Ct) values
Time frame: 48 hours after testing
OPS, NPS and saliva test discomfort and likelihood to get retested
Time frame: immediately after testing (10 minutes)
Ratio of mutations in SARS-CoV-2
Time frame: 48 hours after testing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Derived from this study: PubMed 37208187Todsen 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.
- Derived from this study: PubMed 33832565Todsen 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.
Related trials for SARS-CoV Infection
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Not yet recruiting
Effect of MxA Guidance on Antiviral Treatment in Respiratory Viral Infections
Respiratory Viral Infections, Influenza
Recruiting
Effectiveness of Transcranial Direct Current in Patients With Persistent COVID-19 With Headaches and Chronic Pain.
COVID-19, Long COVID
Active, not recruiting
SARS-COV-2 Seroprevalence and Seroconversion Among Employees of the Universitair Ziekenhuis Brussel Following mRNA COVID-19 Vaccination
SARS-CoV Infection
Active, not recruiting
Clinical Validation of the NowFuture Digital Flu / COVID Test in Anterior Nasal Samples for Over-the-Counter (OTC) Use in Australia
SARS CoV 2 Infection, Influenza A Virus Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobias Todsen, MD, PhD principal investigator
Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Rigshospitalet
Nikolai Kirkby, MD, PhD study director
Department of Clinical Microbiology, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sequence of testing. in people with SARS-CoV Infection and Covid19, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS-CoV-2 detection rates for oropharyngeal swabs (OPS) compared with nasopharyngeal swabs and saliva collection. (time frame: 48 hours after testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04715607, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.