Covid19NCT04877002
Performance Study of SONA Saliva C-19 Rapid Test
A study testing Sona Saliva C-19 Rapid Test in people with Covid19 and Sars-CoV-2 Infection, run by Sona Nanotech Inc at 1 site in Canada.
Trial summary
The Sona Saliva C-19 Rapid Test is a bioassay intended for rapid point-of-care detection of the SARS-CoV-2 virus. Performance of the Sona Saliva C-19 Rapid Test assay will be assessed by comparison to a RT-PCR reference method Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Sars-CoV-2 Infection, Corona Virus Infection
- What is being tested?
- Sona Saliva C-19 Rapid Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 29 Apr 2021to 5 Jan 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
- Up to 500 subjects will be screened, consented, and enrolled to obtain a minimum of 50 eligible candidates. In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Presenting to the Emergency Department at HRH.
- Receiving a COVID-19 RT-PCR test as per standard pathway of care.
- Provide written informed consent.
- Patients must be presenting or have experienced at least one (1) or more signs or symptoms of COVID-19 within ≤ 7 days:
- Fever as self-described or measured ≥ 38 °C (100.4°F)
Show all 18Show fewer
- Chills
- Cough
- Shortness of breath
- Congestion or runny nose
- Difficulty Breathing
- Muscle or Body Aches
- Vomiting
- Diarrhea
- New loss of sense of taste or smell
- Headache
- General malaise
- Sore Throat
Who cannot join
- Asymptomatic patients.
- Patients unable to provide a saliva sample.
- Patients unable to give consent.
- Patients who will not be receiving a nasopharyngeal RT-PCR test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Salivary Rapid Testing of SARS_CoV_2
The Sona Saliva C-19 Rapid Test is a bioassay intended for rapid point-of-care detection of the SARS-CoV-2 virus. Performance of the Sona Saliva C-19 Rapid Test assay will be assessed by comparison to a RT-PCR reference method
Read the detailed description
The clinical performance of the Sona Saliva C-19 Rapid Test will be evaluated in a prospective clinical study conducted at a single (1) investigational site in Toronto, Cananda.
Consenting patients of ages 18+, any gender, or race/ethnicity who presents at the test site with COVID-19 like symptoms during the 2021 COVID-19 season will be asked to take part in the study, will be sequentially enrolled and tested.
Trained operators with laboratory experience who have received training on the use of the Sona Saliva C-19 Rapid Test will conduct the testing and represent the intended users.
A subject's participation in this study will consist of a single visit. Following the completion of the informed consent process, study questionnaire and a review of Inclusion/Exclusion criteria to determine eligibility, each subject will receive a unique study identification number, be asked to provide a sample for testing.
- Conditions
- Covid19, Sars-CoV-2 Infection, Corona Virus Infection
- Being tested
- Sona Saliva C-19 Rapid Test
- Keywords
- Antigen, COVID19, Rapid Test, Saliva
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sona Saliva C-19 Rapid 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 participated in two arms of the study:
One arm was for obtaining performance data of the Sona Saliva C-19 Rapid test and the comparator arm was to obtain data from the primary care route using approved RT-PCR testing. Receives: Diagnostic Test: Sona Saliva C-19 Rapid Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Positive Agreement and Negative Percent Agreement
Calculate the performance of the Sona Saliva C-19 Rapid Test when compared to RT- PCR using nasopharyngeal swab specimens.
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 posted7 May 2021
- Study start29 Apr 2021
- Primary completion10 Jun 2021
- Study completion5 Jan 2022
Why it stopped: Limited participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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 Test for rapid detection of SARS\_CoV\_2 infection when using saliva specimens. A prospective randomized and blinded 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sona Nanotech Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Jacobs, Dr, Principal investigator, Humber River Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877002
- Sponsor's protocol ID
- CT002-SalC19RT
- Status last verified
- Mar 2023
- First submitted
- 3 May 2021
- 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
- Novel Salivary Rapid Testing of SARS_CoV_2
- ClinicalTrials.gov ID
- NCT04877002
- Acronym / sponsor ID
- CT002-SalC19RT
- Conditions
- Covid19, Sars-CoV-2 Infection, Corona Virus Infection
- Keywords
- Antigen, COVID19, Rapid Test, Saliva
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Limited participants
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sona Nanotech IncIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 5 Jan 2022 (actual)
- First posted
- 7 May 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 Sona Saliva C-19 Rapid Test is a bioassay intended for rapid point-of-care detection of the SARS-CoV-2 virus. Performance of the Sona Saliva C-19 Rapid Test assay will be assessed by comparison to a RT-PCR reference method
Detailed description
The clinical performance of the Sona Saliva C-19 Rapid Test will be evaluated in a prospective clinical study conducted at a single (1) investigational site in Toronto, Cananda.
Consenting patients of ages 18+, any gender, or race/ethnicity who presents at the test site with COVID-19 like symptoms during the 2021 COVID-19 season will be asked to take part in the study, will be sequentially enrolled and tested.
Trained operators with laboratory experience who have received training on the use of the Sona Saliva C-19 Rapid Test will conduct the testing and represent the intended users.
A subject's participation in this study will consist of a single visit. Following the completion of the informed consent process, study questionnaire and a review of Inclusion/Exclusion criteria to determine eligibility, each subject will receive a unique study identification number, be asked to provide a sample for testing.
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 Test for rapid detection of SARS_CoV_2 infection when using saliva specimens. A prospective randomized and blinded 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 TestThe same group of patients participated in two arms of the study: One arm was for obtaining performance data of the Sona Saliva C-19 Rapid test and the comparator arm was 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 (18 listed)
- Up to 500 subjects will be screened, consented, and enrolled to obtain a minimum of 50 eligible candidates. In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Presenting to the Emergency Department at HRH.
- Receiving a COVID-19 RT-PCR test as per standard pathway of care.
- Provide written informed consent.
- Patients must be presenting or have experienced at least one (1) or more signs or symptoms of COVID-19 within ≤ 7 days:
Key exclusion criteria (4 listed)
- Asymptomatic patients.
- Patients unable to provide a saliva sample.
- Patients unable to give consent.
- Patients who will not be receiving a nasopharyngeal RT-PCR test.
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 TestRapid Antigen diagnostic device performance comparative to RT-PCR | Diagnostic test | SARS_CoV_2 Antigen Rapid Test |
Primary outcome
Percent Positive Agreement and Negative Percent Agreement
Time frame: 35 days from last patient enrolment
Calculate the performance of the Sona Saliva C-19 Rapid Test when compared to RT- PCR using nasopharyngeal swab specimens.
Results and safety
The study was stopped early (reason given: Limited participants). Results are not available in the source record.
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.
David Jacobs, Dr principal investigator
Humber River Hospital
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 Test in people with Covid19 and 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 18 inclusion and 4 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: stopped early, 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 was stopped early (reason given: Limited participants). Results are not available in the source record.
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 and Negative Percent Agreement (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.