Covid19NCT04473248
Spartan COVID-19 System: Evaluation of Clinical Sample Collection
A study testing Spartan COVID-19 System in people with Covid19, run by Spartan Bioscience Inc. at 2 sites in Canada.
Trial summary
This study will evaluate the efficacy of various sample collection methods for use with the Spartan COVID-19 System. It will compare the results from the Spartan COVID-19 System with results that are obtained using a predicate lab-based COVID-19 test that uses a nasopharyngeal swab sample. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Spartan COVID-19 System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesCanada
- Study dates
- 28 Jun 2020to 30 Aug 2020
- 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
- must have tested positive for COVID-19 via the existing nucleic acid testing method.
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Humber River Hospital
North York, Ontario, M3M 0B2
The Univeristy of Ottawa Heart Institute
Ottawa, Ontario, K1Y4W7
About this study
Official title: Evaluation of Clinical Sample Collection Project: Spartan COVID-19
This study will evaluate the efficacy of various sample collection methods for use with the Spartan COVID-19 System. It will compare the results from the Spartan COVID-19 System with results that are obtained using a predicate lab-based COVID-19 test that uses a nasopharyngeal swab sample. The goal is to determine which sample collection methods are most effective in capturing SARS-CoV-2 virus.
Read the detailed description
Once the subject is recruited,two nasopharyngeal swabs using the standard method will be taken from the patient. Additionally, two nasal swab samples will be taken using the Spartan COVID-19 swabs with an adjusted tip. All samples will be analyzed using the Spartan COVID-19 System.
The lab-based predicate test will be taken at the same time, with results reported back to Spartan to be compared with results obtained from the Spartan COVID-19 System.
- Conditions
- Covid19
- Being tested
- Spartan COVID-19 System
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spartan COVID-19 SystemDevice
PCR analysis of patient samples using the Spartan COVID-19 System
| Study group | Role | What they receive |
|---|---|---|
| Method 1- Nasopharyngeal Swab in transfer liquid | Experimental | A nasopharyngeal swab will inoculate a proprietary solution which will be transferred to the Spartan COVID-19 System for analysis Receives: Device: Spartan COVID-19 System |
| Method 2- Dipping of specialized swab in VTM | Experimental | A nasopharyngeal swab will inoculate VTM solution. A modified traditional Spartan Swab will be dipped into the inoculated VTM solution and then transferred to the Spartan COVID-19 System for analysis. Receives: Device: Spartan COVID-19 System |
| Method 3: Direct input of VTM | Experimental | Using the VTM from Method 2, pipette 10uL of VTM, inoculated with sample, into the Spartan COVID-19 System for analysis. Receives: Device: Spartan COVID-19 System |
| Method 4: Collection of nasal sample. | Experimental | Using a modified tip of the Spartan swab, a nasal sample will be taken from the patient and directly placed into the Spartan COVID-19 System for analysis. Receives: Device: Spartan COVID-19 System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asses the % agreement between predicate results and Spartan COVID-19 results.
The purpose of this study is to evaluate which method has the best % agreement between the lab-based predicate results and Spartan COVID-19 System results.
Measured: Through study completion; anticipated to be less than 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start28 Jun 2020
- Primary completion30 Aug 2020
- Study completion30 Aug 2020
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
- Non-randomised
- Intervention model
- Single group
- Model description
- Each Patient enrolle dint he study will experience the same modes of sample collection and sample analysis.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spartan Bioscience Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Humber River Hospital, The Ottawa Hospital
- Responsible party
- Sponsor
- Investigators
- Tara Linseman, MSc, Study director, Spartan Bioscience Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473248
- Sponsor's protocol ID
- VNV-00552
- Status last verified
- Jul 2020
- First submitted
- 14 Jul 2020
- Last updated
- 13 Nov 2020
- 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 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Sample Collection Project: Spartan COVID-19
- ClinicalTrials.gov ID
- NCT04473248
- Acronym / sponsor ID
- VNV-00552
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Spartan Bioscience Inc.Industry (pharma, biotech, devices)
- Collaborators
- Humber River Hospital, The Ottawa Hospital
- Study start
- 28 Jun 2020 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 16 Jul 2020 (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.
This study will evaluate the efficacy of various sample collection methods for use with the Spartan COVID-19 System. It will compare the results from the Spartan COVID-19 System with results that are obtained using a predicate lab-based COVID-19 test that uses a nasopharyngeal swab sample. The goal is to determine which sample collection methods are most effective in capturing SARS-CoV-2 virus.
Detailed description
Once the subject is recruited,two nasopharyngeal swabs using the standard method will be taken from the patient. Additionally, two nasal swab samples will be taken using the Spartan COVID-19 swabs with an adjusted tip. All samples will be analyzed using the Spartan COVID-19 System.
The lab-based predicate test will be taken at the same time, with results reported back to Spartan to be compared with results obtained from the Spartan COVID-19 System.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Each Patient enrolle dint he study will experience the same modes of sample collection and sample analysis.
| Arm | Type | Receives |
|---|---|---|
| Method 1- Nasopharyngeal Swab in transfer liquid | Experimental | Device: Spartan COVID-19 SystemA nasopharyngeal swab will inoculate a proprietary solution which will be transferred to the Spartan COVID-19 System for analysis |
| Method 2- Dipping of specialized swab in VTM | Experimental | Device: Spartan COVID-19 SystemA nasopharyngeal swab will inoculate VTM solution. A modified traditional Spartan Swab will be dipped into the inoculated VTM solution and then transferred to the Spartan COVID-19 System for analysis. |
| Method 3: Direct input of VTM | Experimental | Device: Spartan COVID-19 SystemUsing the VTM from Method 2, pipette 10uL of VTM, inoculated with sample, into the Spartan COVID-19 System for analysis. |
| Method 4: Collection of nasal sample. | Experimental | Device: Spartan COVID-19 SystemUsing a modified tip of the Spartan swab, a nasal sample will be taken from the patient and directly placed into the Spartan COVID-19 System for analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- must have tested positive for COVID-19 via the existing nucleic acid testing method.
Key exclusion criteria (1 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 |
|---|---|---|
| Spartan COVID-19 SystemPCR analysis of patient samples using the Spartan COVID-19 System | Device | Method 1- Nasopharyngeal Swab in transfer liquid, Method 2- Dipping of specialized swab in VTM, Method 3: Direct input of VTM, Method 4: Collection of nasal sample. |
Primary outcome
Asses the % agreement between predicate results and Spartan COVID-19 results.
Time frame: Through study completion; anticipated to be less than 6 months.
The purpose of this study is to evaluate which method has the best % agreement between the lab-based predicate results and Spartan COVID-19 System results.
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 13 Nov 2020.
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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.
Tara Linseman, MSc study director
Spartan Bioscience Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spartan COVID-19 System in people with Covid19, run by Spartan Bioscience Inc. at 2 sites 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 1 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: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Asses the % agreement between predicate results and Spartan COVID-19 results. (time frame: Through study completion; anticipated to be less than 6 months.). 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 13 Nov 2020.