Covid19RAPID COVIDNCT04767958
The RAPID COVID Study - Application of Point-of-Care COVID-19 Testing
A study testing Spartan COVID-19 Platform in people with Covid19, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial summary
This study is being conducted to study the use and application of a point-of-care (POC) Covid-19 test developed by Spartan BioSciences and recently approved for clinical use by Health Canada. 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 Platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteCanada
- Study dates
- 19 Mar 2021to 31 Aug 2021
- 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
- participants >/= 18 years of age
- patients for whom POC testing would change their course of treatment (in opinion of treatment team)
Who cannot join
- patients in whom conventional COVID-19 testing would not have otherwise been performed
- patients in whom immediate COVID-19 testing would not alter short-term treatment
- patients who refuse consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The RAPID COVID Study - Application of Point-of-Care COVID-19 Testing to Optimize Patient Care, Resource Allocation and Safety for Frontline Staff
This study is being conducted to study the use and application of a point-of-care (POC) Covid-19 test developed by Spartan BioSciences and recently approved for clinical use by Health Canada.
Read the detailed description
This RAPID COVID-19 study is a prospective, unblinded clinical trial. POC testing utilizing the Spartan Cube COVID-19 platform will be performed on a cohort of 2200 hospitalized patients who have been tested for COVID-19.
This cohort will be divided into three groups:
- patients consulted upon by ICU, internal medicine, or cardiology for admission to the hospital
- patients undergoing cardiac testing and/or procedures
- patients awaiting surgery The results from the POC test will be compared to the results from the traditional hospital core lab test to determine sensitivity and specificity of the POC test.
An additional cohort of 500 quarantined health care workers will have the POC test performed and compared with the results from the traditional hospital core lab test.
- Conditions
- Covid19
- Being tested
- Spartan COVID-19 Platform
- 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 PlatformDiagnostic test
Nasal-pharyngeal swab for testing on the Spartan Covid-19 platform
| Study group | Role | What they receive |
|---|---|---|
| Patients consulted upon by ICU, internal medicine, or cardiology for hospital admission | Experimental | All patients will have both standard care and point-of-care (experimental) NP swabs performed. Receives: Diagnostic Test: Spartan COVID-19 Platform |
| patients undergoing cardiac testing/procedures | Experimental | All patients will have both standard care and point-of-care (experimental) NP swabs performed. Receives: Diagnostic Test: Spartan COVID-19 Platform |
| patients awaiting surgery | Experimental | All patients will have both standard care and point-of-care (experimental) NP swabs performed. Receives: Diagnostic Test: Spartan COVID-19 Platform |
| Health Care Workers | Experimental | Health Care Workers who are being screened for COVID-19 will have both standard care and point-of-care NP swabs performed. Receives: Diagnostic Test: Spartan COVID-19 Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of POC testing as compared to core lab testing
Specificity, positive/negative predictive values will be derived
Measured: 3 months
Secondary outcomes (1)
Incidence in which decision making would have been altered by POC testing
examples include: ventilation decisions, use of ICU/isolation rooms, use of PPE, additional testing
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start19 Mar 2021
- Primary completion31 May 2021
- Study completion31 Aug 2021
Why it stopped: Device pulled from market due to inconsistent results.
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.
- More trials run by Ottawa Heart Institute Research CorporationThe 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
- This is a cohort study of participants falling into one of four groups.
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767958
- Sponsor's protocol ID
- 20200858-01T
- Acronym
- RAPID COVID
- Status last verified
- Apr 2022
- First submitted
- 19 Feb 2021
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RAPID COVID Study - Application of Point-of-Care COVID-19 Testing to Optimize Patient Care, Resource Allocation and Safety for Frontline Staff
- ClinicalTrials.gov ID
- NCT04767958
- Acronym / sponsor ID
- RAPID COVID / 20200858-01T
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Device pulled from market due to inconsistent results.
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 23 Feb 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.
This study is being conducted to study the use and application of a point-of-care (POC) Covid-19 test developed by Spartan BioSciences and recently approved for clinical use by Health Canada.
Detailed description
This RAPID COVID-19 study is a prospective, unblinded clinical trial. POC testing utilizing the Spartan Cube COVID-19 platform will be performed on a cohort of 2200 hospitalized patients who have been tested for COVID-19.
This cohort will be divided into three groups:
- patients consulted upon by ICU, internal medicine, or cardiology for admission to the hospital
- patients undergoing cardiac testing and/or procedures
- patients awaiting surgery The results from the POC test will be compared to the results from the traditional hospital core lab test to determine sensitivity and specificity of the POC test.
An additional cohort of 500 quarantined health care workers will have the POC test performed and compared with the results from the traditional hospital core lab test.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a cohort study of participants falling into one of four groups.
| Arm | Type | Receives |
|---|---|---|
| Patients consulted upon by ICU, internal medicine, or cardiology for hospital admission | Experimental | Diagnostic Test: Spartan COVID-19 PlatformAll patients will have both standard care and point-of-care (experimental) NP swabs performed. |
| patients undergoing cardiac testing/procedures | Experimental | Diagnostic Test: Spartan COVID-19 PlatformAll patients will have both standard care and point-of-care (experimental) NP swabs performed. |
| patients awaiting surgery | Experimental | Diagnostic Test: Spartan COVID-19 PlatformAll patients will have both standard care and point-of-care (experimental) NP swabs performed. |
| Health Care Workers | Experimental | Diagnostic Test: Spartan COVID-19 PlatformHealth Care Workers who are being screened for COVID-19 will have both standard care and point-of-care NP swabs performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- participants >/= 18 years of age
- patients for whom POC testing would change their course of treatment (in opinion of treatment team)
Key exclusion criteria (3 listed)
- patients in whom conventional COVID-19 testing would not have otherwise been performed
- patients in whom immediate COVID-19 testing would not alter short-term treatment
- patients who refuse 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 |
|---|---|---|
| Spartan COVID-19 PlatformNasal-pharyngeal swab for testing on the Spartan Covid-19 platform | Diagnostic test | Health Care Workers, Patients consulted upon by ICU, internal medicine, or cardiology for hospital admission, patients awaiting surgery, patients undergoing cardiac testing/procedures |
Primary outcome
Sensitivity of POC testing as compared to core lab testing
Time frame: 3 months
Specificity, positive/negative predictive values will be derived
1 secondary outcome
Incidence in which decision making would have been altered by POC testing
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Device pulled from market due to inconsistent results.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- 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 Spartan COVID-19 Platform in people with Covid19, run by Ottawa Heart Institute Research Corporation 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 2 inclusion and 3 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 2 May 2022. 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: Device pulled from market due to inconsistent results.). 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?
Sensitivity of POC testing as compared to core lab testing (time frame: 3 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 2 May 2022.