Covid19NCT04878068
Study to Evaluate the Performance of the Therma COVID-19 Rapid Antigen Test for Detection of SARS-CoV-2
An observational study of Covid19, run by Cannabis Research Associates.
Trial summary
The Therma COVID-19 Rapid Antigen Test is an in vitro rapid, lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in human saliva specimens. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Theram COVID-19 Rapid Antigen Test
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2021to 30 Jun 2021
- Phase
- Observational
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Potential participants attending a COVID-19 testing centre for a PCR test will be approached to determine eligibility and obtain consent after they have had their PCR test completed. Three hundred participants will be recruited into the study.
Who may be able to join
- Participant is willing to sign verbal informed consent form
- Age 12 or older and parents or legal guardians must consent for children as required by law.
- Participant is attending COVID-19 testing centre for a nasopharyngeal swab sample
- Participant is willing to provide a self-collected saliva sample
Who cannot join
- 1. Participant has previously tested positive for COVID-19 within the past 90 days
Trial locations and contacts
No sites are listed yet.
Ira Price, MD contact
About this study
Official title: POC Study to Evaluate the Performance of the Therma COVID-19 Rapid Antigen Test for Detection of SARS-CoV-2 Virus in Human Saliva
The Therma COVID-19 Rapid Antigen Test is an in vitro rapid, lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in human saliva specimens. This test is intended for near-patient use at the point-of-care or lay person, self-use in a non-laboratory or home setting using saliva samples from individuals with or without symptoms of COVID-19.
The Therma COVID-19 Rapid Antigen Test will be compared to a Health Canada approved RT-PCR COVID-19 test. Nasopharyngeal (for RT-PCR) samples will be collected at a COVID-19 Testing centre and saliva (for the rapid antigen test) samples will be collected and compared.
The prospective, observational, feasibility study will test 300 participants to establish the performance characteristics of the test on saliva specimens.
- Conditions
- Covid19
- Being tested
- Theram COVID-19 Rapid Antigen Test
- Keywords
- Saliva Antigen, Rapid Saliva 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.
Theram COVID-19 Rapid Antigen TestDevice
The Therma COVID-19 Rapid Antigen Test is an in vitro rapid, lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in human saliva specimens. This test is intended for near-patient use at the point-of-care or lay person, self-use in a non-laboratory or home setting using saliva samples from individuals with or without symptoms of COVID-19.
| Study group | Role | What they receive |
|---|---|---|
| Rapid Antigen Saliva Test | Participants who have had a COVID-19 PCR test will self-administer the saliva test. The research team will conduct the processing of the test for the results of positive, negative or inconclusive Receives: Device: Theram COVID-19 Rapid Antigen Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish Performance of Therma COVID-19 Rapid Antigen Test
To establish the performance characteristics of the Therma COVID-19 Rapid Antigen Test in a near-patient, point-of-care (POC) setting with lay users (no laboratory experience) testing a participant that has self-collected the saliva specimen. Clinical accuracy of the rapid antigen test compared to RT-PCR test results. Accuracy refers to the (PPA, positive percent agreement (sensitivity) and (NPA, negative percent agreement (specificity) between the results of the tests. The expected performance of the test for symptomatic participants shall be >90% PPA and >98% NPA.
Measured: 1 day
Secondary outcomes (2)
Participant Feedback
Evaluate participant feedback on the usability of the Therma COVID-19 Rapid Antigen Test and saliva collection device using the Participant Study Questionnaire Form (Ease of use 5-point scale from 5=Easy to 1=Hard)
Measured: 1 day
User Feedback
Evaluate user feedback on the usability of the Therma COVID-19 Rapid Antigen Test and saliva collection device using the Therma Feasibility Study User Feedback Questionnaire (ease of use 5-point scale from Not at all to Very easy)
Measured: 1 day
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 start15 May 2021 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cannabis Research Associates
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ira Price, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878068
- Sponsor's protocol ID
- TB20
- Status last verified
- Apr 2021
- First submitted
- 27 Apr 2021
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POC Study to Evaluate the Performance of the Therma COVID-19 Rapid Antigen Test for Detection of SARS-CoV-2 Virus in Human Saliva
- ClinicalTrials.gov ID
- NCT04878068
- Acronym / sponsor ID
- TB20
- Conditions
- Covid19
- Keywords
- Saliva Antigen, Rapid Saliva Test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Cannabis Research AssociatesUniversity, hospital or other
- Study start
- 15 May 2021 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- 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 Therma COVID-19 Rapid Antigen Test is an in vitro rapid, lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in human saliva specimens. This test is intended for near-patient use at the point-of-care or lay person, self-use in a non-laboratory or home setting using saliva samples from individuals with or without symptoms of COVID-19.
The Therma COVID-19 Rapid Antigen Test will be compared to a Health Canada approved RT-PCR COVID-19 test. Nasopharyngeal (for RT-PCR) samples will be collected at a COVID-19 Testing centre and saliva (for the rapid antigen test) samples will be collected and compared.
The prospective, observational, feasibility study will test 300 participants to establish the performance characteristics of the test on saliva specimens.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rapid Antigen Saliva Test | – | Device: Theram COVID-19 Rapid Antigen TestParticipants who have had a COVID-19 PCR test will self-administer the saliva test. The research team will conduct the processing of the test for the results of positive, negative or inconclusive |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Potential participants attending a COVID-19 testing centre for a PCR test will be approached to determine eligibility and obtain consent after they have had their PCR test completed. Three hundred participants will be recruited into the study.
Key inclusion criteria (4 listed)
- Participant is willing to sign verbal informed consent form
- Age 12 or older and parents or legal guardians must consent for children as required by law.
- Participant is attending COVID-19 testing centre for a nasopharyngeal swab sample
- Participant is willing to provide a self-collected saliva sample
Key exclusion criteria (1 listed)
- 1. Participant has previously tested positive for COVID-19 within the past 90 days
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 |
|---|---|---|
| Theram COVID-19 Rapid Antigen TestThe Therma COVID-19 Rapid Antigen Test is an in vitro rapid, lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in human saliva specimens. This test is intended for near-patient use at the point-of-care or lay person, self-use in a non-laboratory or home setting using saliva samples from individuals with or without symptoms of COVID-19. | Device | Rapid Antigen Saliva Test |
Primary outcome
Establish Performance of Therma COVID-19 Rapid Antigen Test
Time frame: 1 day
To establish the performance characteristics of the Therma COVID-19 Rapid Antigen Test in a near-patient, point-of-care (POC) setting with lay users (no laboratory experience) testing a participant that has self-collected the saliva specimen. Clinical accuracy of the rapid antigen test compared to RT-PCR test results. Accuracy refers to the (PPA, positive percent agreement (sensitivity) and (NPA, negative percent agreement (specificity) between the results of the tests. The expected performance of the test for symptomatic participants shall be >90% PPA and >98% NPA.
2 secondary outcomes
Participant Feedback
Time frame: 1 day
User Feedback
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
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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.
Ira Price, MD contact
Ira Price, MD principal investigator
McMaster University
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Cannabis Research Associates.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa Patterson, BA (289-230-3605, lisap1636@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish Performance of Therma COVID-19 Rapid Antigen Test (time frame: 1 day). 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 7 May 2021.