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

Covid19 Clinical Trial

— RAPID COVID  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04767958
• Other study ID #: 20200858-01T
• Status: Terminated
• Phase: N/A
• Start date: March 19, 2021
• Est. completion date: August 31, 2021

Study information

• Verified date: April 2022
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 89
• Est. completion date: August 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• participants >/= 18 years of age

• patients for whom POC testing would change their course of treatment (in opinion of treatment team)

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Diagnostic Test:
• Spartan COVID-19 Platform
Nasal-pharyngeal swab for testing on the Spartan Covid-19 platform

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
Other	In hospital outcomes	In hospital outcomes include death, pneumonia, intubation, myocardial infarction, urgent revascularization,mechanical device support, transplant	16 months
Other	Length of hospital admission	Total number of days in hospital will be collected	16 months
Primary	Sensitivity of POC testing as compared to core lab testing	Specificity, positive/negative predictive values will be derived	3 months
Secondary	Incidence in which decision making would have been altered by POC testing	examples include: ventilation decisions, use of ICU/isolation rooms, use of PPE, additional testing	12 months