Sars-CoV-2 InfectionNCT05256589
Clinical Evaluation of the SONA Saliva C-19 Rapid Self-Test for the Detection of COVID-19
A study testing Sona Saliva C-19 Rapid Self-test in people with Sars-CoV-2 Infection, run by Sona Nanotech Inc at 1 site in Canada.
Trial summary
The Sona Saliva C-19 Rapid Self-Test is a lateral flow assay intended for detection of the SARS-CoV-2 virus. Performance of the Sona Saliva C-19 Rapid Test assay will be assessed by comparison to an RT-PCR reference method. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sars-CoV-2 Infection
- What is being tested?
- Sona Saliva C-19 Rapid Self-test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- 19 Apr 2022to 19 May 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18+ years
- Presenting at designated NS Health Central Zone COVID-19 PCR testing sites.
- Receiving a RT-PCR COVID-19 test as per standard of care (nasopharyngeal/mid-turbinate swabs).
- Unvaccinated, partially vaccinated, fully vaccinated and fully vaccinated-boosted patients
- Provide written informed consent..
- Patients may have recently been exposed, in close contact, show no symptoms or may be presenting or have experienced at least one (1) or more signs or symptoms of COVID-19 within ≤ 6 days:
Show all 17Show fewer
- Fever as self-described or measured ≥ 38 °C (100.4°F)
- Chills
- Cough
- Shortness of Breath
- Congestion or Runny Nose
- Difficulty Breathing
- Muscle or Body Aches
- Vomiting
- Diarrhoea
- New loss of sense of taste or smell
- General malaise All patients in whom a test result (positive or negative) is obtained from both the RT-PCR testing and Sona Saliva C-19 Rapid Self-test, will be included in the performance analysis.
Who cannot join
- All patients from whom a non-valid result is obtained from either or both the RT-PCR testing and Sona Saliva C-19 Rapid Self-test will be excluded in the analysis for sensitivity and specificity and will be noted as a test error.
- Any rapid tests that produced an invalid test result will be noted as a test error and secondary analysis will be conducted on this cohort of patients to understand any underlying causation.
- Patients recruited into the study that are recorded to have consumed anything orally within 30 minutes of conducting a rapid self-test, as per the warnings laid out in the IFU, may be excluded from the analysis to mitigate any interference risks relating to test outcome.
- Also, the following:
- Patients unable to provide a saliva sample for rapid testing
- Patients unable to provide written consent.
- Patients previously enrolled in the study
- Patients undergoing treatment currently and/or within the past thirty (30) days of the study with prescription medication to treat novel Coronavirus SARS-CoV-2 infection
Trial locations and contacts
1 site in 1 country.
Canada1 site
COVID-19 Assessment centre @bayers lake
Halifax, Nova Scotia, B3s1c5
About this study
The Sona Saliva C-19 Rapid Self-Test is a lateral flow assay intended for detection of the SARS-CoV-2 virus. Performance of the Sona Saliva C-19 Rapid Test assay will be assessed by comparison to an RT-PCR reference method.
Read the detailed description
This is a prospective, non-randomized clinical evaluation study being carried out in the intended use population in which fresh saliva samples are collected, tested, and interpreted by lay-users and the results are compared to samples evaluated with an authorized high sensitivity molecular RT-PCR test.
The device to be studied is the Sona Saliva C-19 Rapid Self Test.
Participants will be recruited into the study who present at a NS Health Central Zone COVID-19 PCR testing site for COIVID-19 testing. This study does not involve any additional study visits, and all participants will receive the current standard of care.
Patients will provide their RT-PCR sample as per the established testing processes at the health centre and will receive their results through the standard communication pathway. Self-testing using the Sona assay will be conducted at the COVID -19 testing center by individuals in real time.
The participants will be instructed as to not act on the result of their Sona saliva assay, but rather await the gold standard result of RT-PCR.
A usability questionnaire will also be completed by individuals.
- Conditions
- Sars-CoV-2 Infection
- Being tested
- Sona Saliva C-19 Rapid Self-test
- Keywords
- Antigen, COVID19, Rapid Test, Saliva, Self-test
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sona Saliva C-19 Rapid Self-testDiagnostic test
Rapid Antigen diagnostic device performance comparative to RT-PCR
| Study group | Role | What they receive |
|---|---|---|
| SARS_CoV_2 Antigen Rapid Test | Experimental | The same group of patients participate in two arms of the study:
One arm is for obtaining performance data of the Sona Saliva C-19 Rapid self test and the comparator arm is to obtain data from the primary care route using approved RT-PCR testing. Receives: Diagnostic Test: Sona Saliva C-19 Rapid Self-test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Positive Agreement (Sensitivity) and Negative Percent Agreement (Specificity)
Calculate the performance of the Sona Saliva C-19 Rapid Self Test when compared to RT- PCR
Measured: 35 days from last patient enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start19 Apr 2022
- Primary completion26 Apr 2022
- Study completion19 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sars-CoV-2 InfectionStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- The purpose of this study is to validate the performance of the Sona Saliva C-19 rapid Self-Test for detection of SARS\_CoV\_2 infection when using saliva specimens. A prospective study to evaluate a rapid point of care antigen test for the detection of viral proteins and compared against an approved RT-PCR test. Saliva samples will be collected along with the current standard of care collection.
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sona Nanotech Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nova Scotia Health Authority
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256589
- Sponsor's protocol ID
- DHF009 - NSHCT
- Status last verified
- Mar 2023
- First submitted
- 16 Feb 2022
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the SONA Saliva C-19 Rapid Self-Test for the Detection of COVID-19
- ClinicalTrials.gov ID
- NCT05256589
- Acronym / sponsor ID
- DHF009 - NSHCT
- Conditions
- Sars-CoV-2 Infection
- Keywords
- Antigen, COVID19, Rapid Test, Saliva, Self-test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Sona Nanotech IncIndustry (pharma, biotech, devices)
- Collaborators
- Nova Scotia Health Authority
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 26 Apr 2022 (actual)
- Study completion
- 19 May 2022 (actual)
- First posted
- 25 Feb 2022 (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 Sona Saliva C-19 Rapid Self-Test is a lateral flow assay intended for detection of the SARS-CoV-2 virus. Performance of the Sona Saliva C-19 Rapid Test assay will be assessed by comparison to an RT-PCR reference method.
Detailed description
This is a prospective, non-randomized clinical evaluation study being carried out in the intended use population in which fresh saliva samples are collected, tested, and interpreted by lay-users and the results are compared to samples evaluated with an authorized high sensitivity molecular RT-PCR test.
The device to be studied is the Sona Saliva C-19 Rapid Self Test.
Participants will be recruited into the study who present at a NS Health Central Zone COVID-19 PCR testing site for COIVID-19 testing. This study does not involve any additional study visits, and all participants will receive the current standard of care.
Patients will provide their RT-PCR sample as per the established testing processes at the health centre and will receive their results through the standard communication pathway. Self-testing using the Sona assay will be conducted at the COVID -19 testing center by individuals in real time.
The participants will be instructed as to not act on the result of their Sona saliva assay, but rather await the gold standard result of RT-PCR.
A usability questionnaire will also be completed by individuals.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The purpose of this study is to validate the performance of the Sona Saliva C-19 rapid Self-Test for detection of SARS_CoV_2 infection when using saliva specimens. A prospective study to evaluate a rapid point of care antigen test for the detection of viral proteins and compared against an approved RT-PCR test. Saliva samples will be collected along with the current standard of care collection.
| Arm | Type | Receives |
|---|---|---|
| SARS_CoV_2 Antigen Rapid Test | Experimental | Diagnostic Test: Sona Saliva C-19 Rapid Self-testThe same group of patients participate in two arms of the study: One arm is for obtaining performance data of the Sona Saliva C-19 Rapid self test and the comparator arm is to obtain data from the primary care route using approved RT-PCR testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Aged ≥ 18+ years
- Presenting at designated NS Health Central Zone COVID-19 PCR testing sites.
- Receiving a RT-PCR COVID-19 test as per standard of care (nasopharyngeal/mid-turbinate swabs).
- Unvaccinated, partially vaccinated, fully vaccinated and fully vaccinated-boosted patients
- Provide written informed consent..
Key exclusion criteria (8 listed)
- All patients from whom a non-valid result is obtained from either or both the RT-PCR testing and Sona Saliva C-19 Rapid Self-test will be excluded in the analysis for sensitivity and specificity and will be noted as a test error.
- Any rapid tests that produced an invalid test result will be noted as a test error and secondary analysis will be conducted on this cohort of patients to understand any underlying causation.
- Patients recruited into the study that are recorded to have consumed anything orally within 30 minutes of conducting a rapid self-test, as per the warnings laid out in the IFU, may be excluded from the analysis to mitigate any interference risks relating to test outcome.
- Patients unable to provide a saliva sample for rapid testing
- Patients unable to provide written consent.
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 |
|---|---|---|
| Sona Saliva C-19 Rapid Self-testRapid Antigen diagnostic device performance comparative to RT-PCR | Diagnostic test | SARS_CoV_2 Antigen Rapid Test |
Primary outcome
Percent Positive Agreement (Sensitivity) and Negative Percent Agreement (Specificity)
Time frame: 35 days from last patient enrolment
Calculate the performance of the Sona Saliva C-19 Rapid Self Test when compared to RT- PCR
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 24 Mar 2023.
- Individual participant dataSharing planned: No
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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 Sona Saliva C-19 Rapid Self-test in people with Sars-CoV-2 Infection, run by Sona Nanotech Inc at 1 site in Canada.
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 17 inclusion and 8 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 24 Mar 2023. 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 Canada. 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?
Percent Positive Agreement (Sensitivity) and Negative Percent Agreement (Specificity) (time frame: 35 days from last patient enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2023.