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TerminatedNCT04353154Updated May 13, 2026

The RAPID COVID-19 TRIAGE Algorithm

An observational study in COVID-19, sponsored by Ottawa Heart Institute Research Corporation. Terminated at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-13.

Sponsored by Ottawa Heart Institute Research Corporation · Observational

Why this study was terminated
Health Canada revoked the device due to inaccurate results. Study was unable to be completed and data collected to date determined to be invalid.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
66
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Currently, testing for COVID-19 is carried out with swabs and blood tests that are sent to hospital laboratories for analysis. With the current technology, the turnaround time for test results may take any where from 8 hours up to several days for confirmation of whether you have COVID-19. This delay in diagnosis may delay care, prevent other testing modalities, consume isolation beds and deplete the valuable personal protective equipment (PPE) needed while providing treatment for patients with COVID-19.

Using a new, Health Canada approved technology, we can conduct the virus genetic testing at the bedside with a nostril and throat swab, with results in under 45 minutes. This new "point-of-care (POC)" technology, if proven accurate, may help future patients receive faster and more definitive treatment. At the same time, it might help health care teams to preserve resources and optimize care for patients (example: triage use of intensive care or isolation unit beds, determine need for PPE, get quarantined staff back to front line to help with care if they are non-carriers).

02

Conditions studied

  • COVID-19

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03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 66 is below the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Ottawa Heart Institute Research Corporation is the lead sponsor of 179 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Study population is admitted patients who have had a positive core-lab virology test for COVID-19.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
66 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testSpartan Cube Point-of Care Covid-19 test

    Throat and nasal swab for COVID-19 point-of-care test.

06

What researchers measure

Primary outcomes

  1. Sensitivity

    For the analysis, this will be based on a comparison of the identified patients in the core lab with the POC testing with the following data to arrive at an early sensitivity: Sensitivity = True Positive/ (True positive/True positive + False Negative)

    Time frame: 1 month

07

Study locations

1 site
  • University of Ottawa Heart Institute
    Ottawa, Ontario K1N 4W7, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04353154
Lead sponsor
Ottawa Heart Institute Research Corporation
Responsible party
Sponsor
First posted
Apr 20, 2020
Start date
Jun 15, 2020
Primary completion
May 17, 2022
Completion
May 17, 2022
Last update
May 13, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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