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

University of Ottawa Heart Institute

Status: Terminated

Conditions: Covid19

Treatments: Diagnostic Test: Spartan COVID-19 Platform

Study type: Interventional

Funder types: Other

Identifiers

NCT04767958

20200858-01T

Details and patient eligibility

About

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.

Full 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.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

89 participants in 4 patient groups

Patients consulted upon by ICU, internal medicine, or cardiology for hospital admission

Experimental group

Description:

All patients will have both standard care and point-of-care (experimental) NP swabs performed.

Treatment:

Diagnostic Test: Spartan COVID-19 Platform

patients undergoing cardiac testing/procedures

Experimental group

Description:

All patients will have both standard care and point-of-care (experimental) NP swabs performed.

Treatment:

Diagnostic Test: Spartan COVID-19 Platform

patients awaiting surgery

Experimental group

Description:

All patients will have both standard care and point-of-care (experimental) NP swabs performed.

Treatment:

Diagnostic Test: Spartan COVID-19 Platform

Health Care Workers

Experimental group

Description:

Health Care Workers who are being screened for COVID-19 will have both standard care and point-of-care NP swabs performed.

Treatment:

Diagnostic Test: Spartan COVID-19 Platform