The RAPID COVID-19 TRIAGE Algorithm

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-15

Study Completion Date

2026-06-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Spartan Cube Point-of Care Covid-19 test

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20200228-01H

Identifier Type: -

Identifier Source: org_study_id