- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04353154
The RAPID COVID-19 TRIAGE Algorithm
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
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ontario
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Ottawa, Ontario, Canada, K1N 4W7
- University of Ottawa Heart Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensitivity
Time Frame: 1 month
|
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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20200228-01H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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