The RAPID COVID Study - Application of Point-of-Care COVID-19 Testing

Not Applicable

Terminated

• Conditions: Covid19
• Interventions: Diagnostic Test: Spartan COVID-19 Platform

• Registration Number: NCT04767958
• Lead Sponsor: Ottawa Heart Institute Research Corporation

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.

Study Timeline

• Study First Submitted: 2021-02-19
• Study First Submitted QC: 2021-02-22
• Study First Posted: 2021-02-23
• Study Start: 2021-03-19
• Primary Completion: 2021-05-31
• Study Completion: 2021-08-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-25
• Last Update Posted: 2022-05-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

• participants >/= 18 years of age
• patients for whom POC testing would change their course of treatment (in opinion of treatment team)

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Exclusion Criteria

• patients in whom conventional COVID-19 testing would not have otherwise been performed
• patients in whom immediate COVID-19 testing would not alter short-term treatment
• patients who refuse consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients awaiting surgery	Spartan COVID-19 Platform	All patients will have both standard care and point-of-care (experimental) NP swabs performed.
Health Care Workers	Spartan COVID-19 Platform	Health Care Workers who are being screened for COVID-19 will have both standard care and point-of-care NP swabs performed.
Patients consulted upon by ICU, internal medicine, or cardiology for hospital admission	Spartan COVID-19 Platform	All patients will have both standard care and point-of-care (experimental) NP swabs performed.
patients undergoing cardiac testing/procedures	Spartan COVID-19 Platform	All patients will have both standard care and point-of-care (experimental) NP swabs performed.

Primary Outcome Measures

Name	Time	Method
Sensitivity of POC testing as compared to core lab testing	3 months	Specificity, positive/negative predictive values will be derived

Secondary Outcome Measures

Name	Time	Method
Incidence in which decision making would have been altered by POC testing	12 months	examples include: ventilation decisions, use of ICU/isolation rooms, use of PPE, additional testing

Trial Locations

Locations (1)

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada