The RAPID COVID-19 TRIAGE Algorithm

COVID-19 Clinical Trial

Official title:

Development and Evaluation of Applying a Point-of-Care COVID-19 Test Strategy to Triage Patients Presenting With Acute Coronary Syndromes, Respiratory or Hemodynamic Instability and Out of Hospital Cardiac Arrests

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04353154
• Other study ID #: 20200228-01H
• Status: Active, not recruiting
• Start date: June 15, 2020
• Est. completion date: June 28, 2024

Study information

• Verified date: October 2023
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 66
• Est. completion date: June 28, 2024
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Diagnostic Test:
• Spartan Cube Point-of Care Covid-19 test
Throat and nasal swab for COVID-19 point-of-care test.

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	1 month