Covid-19NCT04599959

COVID-19 Tests: Nasopharyngeal Swab vs Saliva Collected With Salivette® Cortisol for Viral RNA Sampling for RT-qPCR

A study testing Sampling of SARS-CoV-2 RNA from nasopharyngeal swab specimen or saliva collected via Salivette Cortisol in people with Covid-19, run by Boehringer Ingelheim at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main objective of the tests is to establish saliva collection with Salivette® Cortisol. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Covid-19
What is being tested?: Sampling of SARS-CoV-2 RNA from nasopharyngeal swab specimen or saliva collected via Salivette Cortisol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 151 participants
Where: 1 siteMexico
Study dates: 26 Oct 2020to 20 Jan 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Informed consent form signed and dated before any samples have been taken.
Suspected or confirmed SARS-CoV-2 infection by PCR within the past five days.
Male and/or female patients aged 18 years and over.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas
México, 14080

Other trials in Mexico

About this study

Official title: COVID-19 Tests: a Systematic Comparison of Viral RNA Test Sample Taking for RT-qPCR, in This Case With a Nasopharyngeal Swab or Saliva Collected With Salivette® Cortisol, to Diagnose SARS-CoV-2 Virus Infection

The main objective of the tests is to establish saliva collection with Salivette® Cortisol.

Conditions: Covid-19
Being tested: Sampling of SARS-CoV-2 RNA from nasopharyngeal swab specimen or saliva collected via Salivette Cortisol
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sampling of SARS-CoV-2 RNA from nasopharyngeal swab specimen or saliva collected via Salivette CortisolDiagnostic test
Kylt® for detection/confirmation of SARS-CoV-2 cobas® SARS-CoV-2 (PCR) test TaqPath™ COVID-19 CE-IVD RT-PCR kit

Study groups in NCT04599959
Study group	Role	What they receive
Overall (Swab/Saliva)	Experimental	Not described Receives: Diagnostic Test: Sampling of SARS-CoV-2 RNA from nasopharyngeal swab specimen or saliva collected via Salivette Cortisol

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Testing Positive or Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Mexico
Number of participants testing positive or negative for SARS-CoV-2 virus from sample collected via swab versus saliva sample collected from Salivette® Cortisol, which samples were processed in Mexico.
Measured: At baseline (the test day), up to one day.
Percentage of Participants Testing True Positive or True Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Germany
Percentage of participants testing true positive or true negative for SARS-CoV-2 virus from Swab and Saliva samples being processed in Germany was reported. The swab sample was used as the reference. Among participants who were tested positive from swab samples, those who were tested positive from saliva samples were classified as "true positive". Among participants tested negative from swab samples, those who were tested negative from saliva samples were then classified as "true negative".
Measured: At baseline (the test day), up to one day.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Oct 202020 Jan 2021

First posted23 Oct 2020
Study start26 Oct 2020
Primary completion20 Jan 2021
Study completion20 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Covid-19Studies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe 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: Non-randomised
Intervention model: Single group
Model description: Comparison of SARS-CoV-2-RNA detectability in Swab and Salivette samples.
Masking: None (open label)
Enrolment: 151 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04599959
Sponsor's protocol ID: 0352-2150
Status last verified: Jul 2021
First submitted: 22 Oct 2020
Last updated: 26 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: http://trials.boehringer-ingelheim.com/

Publications

Moroni-Zentgraf P, Keller C, Eschenfelder CC, Walter Muller H, Sigmund R, Galeana-Cadena D, Marquez-Garcia JE, Moncada-Morales A, Zuniga JA. Salivette(R) Cortisol versus oropharyngeal swabbing for the detection of SARS-CoV-2 infection. Expert Rev Mol Diagn. 2023 Jul-Dec;23(11):1011-1014. doi: 10.1080/14737159.2023.2260308. Epub 2023 Oct 24.
PubMed 37724431

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: COVID-19 Tests: a Systematic Comparison of Viral RNA Test Sample Taking for RT-qPCR, in This Case With a Nasopharyngeal Swab or Saliva Collected With Salivette® Cortisol, to Diagnose SARS-CoV-2 Virus Infection
ClinicalTrials.gov ID: NCT04599959
Acronym / sponsor ID: 0352-2150
Conditions: Covid-19
Study type: Interventional
Recruitment status: Completed
Enrolment: 151 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 26 Oct 2020 (actual)
Primary completion: 20 Jan 2021 (actual)
Study completion: 20 Jan 2021 (actual)
First posted: 23 Oct 2020 (actual)
Results: Posted 26 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The main objective of the tests is to establish saliva collection with Salivette® Cortisol.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Comparison of SARS-CoV-2-RNA detectability in Swab and Salivette samples.

Arm	Type	Receives
Overall (Swab/Saliva)	Experimental	Diagnostic Test: Sampling of SARS-CoV-2 RNA from nasopharyngeal swab specimen or saliva collected via Salivette Cortisol

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Informed consent form signed and dated before any samples have been taken.
Suspected or confirmed SARS-CoV-2 infection by PCR within the past five days.
Male and/or female patients aged 18 years and over.

Key exclusion criteria (0 listed)

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
Sampling of SARS-CoV-2 RNA from nasopharyngeal swab specimen or saliva collected via Salivette CortisolKylt® for detection/confirmation of SARS-CoV-2 cobas® SARS-CoV-2 (PCR) test TaqPath™ COVID-19 CE-IVD RT-PCR kit	Diagnostic test	Overall (Swab/Saliva)

Primary outcome

Number of Participants Testing Positive or Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Mexico
Time frame: At baseline (the test day), up to one day.
Number of participants testing positive or negative for SARS-CoV-2 virus from sample collected via swab versus saliva sample collected from Salivette® Cortisol, which samples were processed in Mexico.
Percentage of Participants Testing True Positive or True Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Germany
Time frame: At baseline (the test day), up to one day.
Percentage of participants testing true positive or true negative for SARS-CoV-2 virus from Swab and Saliva samples being processed in Germany was reported. The swab sample was used as the reference. Among participants who were tested positive from swab samples, those who were tested positive from saliva samples were classified as "true positive". Among participants tested negative from swab samples, those who were tested negative from saliva samples were then classified as "true negative".

Results and safety

Results posted to the registry on 26 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall	151	151

Primary outcome: Number of Participants Testing Positive or Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Mexico

Time frame: At baseline (the test day), up to one day.. Count of participants. Unit: Participants

Measure	Swab - Processed in Mexico n = 151	Saliva - Processed in Mexico n = 103
Positive	85	13
Negative	66	89
Ambiguous	0	1

Population analysed: All eligible participants in this study who had been diagnosed with COVID-19 confirmed by polymerase chain reaction (PCR) test within the past 5 days before study entry, and whose samples were processed in Mexico.

Primary outcome: Percentage of Participants Testing True Positive or True Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Germany

Time frame: At baseline (the test day), up to one day.. Number. Unit: Percentage of participants

Measure	Swab+Saliva - Processed in Germany n = 141
True positive (sensitivity)	52.2
True negative (specificity)	100.0

Adverse events

Time frame: Up to 1 day.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Overall	0 of 151 (0%)	0 of 151 (0%)	0 of 151

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37724431Moroni-Zentgraf P, Keller C, Eschenfelder CC, Walter Muller H, Sigmund R, Galeana-Cadena D, Marquez-Garcia JE, Moncada-Morales A, Zuniga JA. Salivette(R) Cortisol versus oropharyngeal swabbing for the detection of SARS-CoV-2 infection. Expert Rev Mol Diagn. 2023 Jul-Dec;23(11):1011-1014. doi: 10.1080/14737159.2023.2260308. Epub 2023 Oct 24.
Click here to connect to Boehringer Ingelheim Clinical Studies WebsiteLink provided by the sponsor.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: http://trials.boehringer-ingelheim.com/

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Sampling of SARS-CoV-2 RNA from nasopharyngeal swab specimen or saliva collected via Salivette Cortisol in people with Covid-19, run by Boehringer Ingelheim at 1 site in Mexico.

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 3 inclusion and 0 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 26 Jul 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 Mexico. 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?

Yes. Results are posted in the registry (first posted 26 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Testing Positive or Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Mexico (time frame: At baseline (the test day), up to one day.). The study lists 2 primary outcomes in all. 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 NCT04599959, which also lists 1 linked publication.

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 26 Jul 2021.