The RAPID COVID-19 TRIAGE Algorithm (NCT04353154) | Clinical Trial Compass
TerminatedNot Applicable
The RAPID COVID-19 TRIAGE Algorithm
Stopped: Health Canada revoked the device due to inaccurate results. Study was unable to be completed and data collected to date determined to be invalid.
Canada66 participantsStarted 2020-06-15
Plain-language 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. Phase I of this study will determine the best route for the swabs (nasal, throat, or both), and to determine if this POC test results are comparable to the standard core-lab test results.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients ≥ 18 yo referred to the cardiology, internal medicine, ICU, CICU, CSICU or RACE teams who have tested positive for COVID-19.
Exclusion Criteria:
* Patients in whom conventional COVID-19 testing would not have otherwise been instituted or in whom immediate test results would not alter short-term treatment, Patients with pre-existing wishes for DNR.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before completing — do you know why it was stopped, and does that affect whether the RAPID triage algorithm it was studying is still considered useful or reliable for COVID-19 assessment?
2Since this study was measuring 'sensitivity' as its primary outcome, meaning how well the algorithm correctly identifies COVID-19 cases, does the available data tell us anything about whether it missed cases or produced false negatives that I should be aware of?
3Given that this trial was terminated and labeled 'NA' for phase, meaning it may not have gone through the full research process, how much confidence do you have in any findings it produced compared to fully completed COVID-19 triage studies?
4Are there other completed studies or validated triage tools for COVID-19 that you would recommend instead, now that this trial did not finish?
5If this algorithm was being considered as part of my care or triage process, would the fact that the trial was terminated change how you would use or interpret its results in my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sensitivity
Timeframe: 1 month
Trial details
NCT IDNCT04353154
SponsorOttawa Heart Institute Research Corporation