Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT04767958
Status:
TERMINATED
Last Update Posted:
2022-05-02
First Post:
2021-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The RAPID COVID Study - Application of Point-of-Care COVID-19 Testing
Sponsor:
Ottawa Heart Institute Research Corporation
Organization:
Study Overview
Official Title:
The RAPID COVID Study - Application of Point-of-Care COVID-19 Testing to Optimize Patient Care, Resource Allocation and Safety for Frontline Staff
Status:
TERMINATED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Device pulled from market due to inconsistent results.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAPID COVID
Brief 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.
Detailed Description:
This RAPID COVID-19 study is a prospective, unblinded clinical trial. POC testing utilizing the Spartan Cube COVID-19 platform will be performed on a cohort of 2200 hospitalized patients who have been tested for COVID-19.
This cohort will be divided into three groups:
1. patients consulted upon by ICU, internal medicine, or cardiology for admission to the hospital
2. patients undergoing cardiac testing and/or procedures
3. patients awaiting surgery The results from the POC test will be compared to the results from the traditional hospital core lab test to determine sensitivity and specificity of the POC test.
An additional cohort of 500 quarantined health care workers will have the POC test performed and compared with the results from the traditional hospital core lab test.
This cohort will be divided into three groups:
1. patients consulted upon by ICU, internal medicine, or cardiology for admission to the hospital
2. patients undergoing cardiac testing and/or procedures
3. patients awaiting surgery The results from the POC test will be compared to the results from the traditional hospital core lab test to determine sensitivity and specificity of the POC test.
An additional cohort of 500 quarantined health care workers will have the POC test performed and compared with the results from the traditional hospital core lab test.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: