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

NCT04767958 | Terminated DMC

• 1 other identifier: 20200858-01T
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Sensitivity of POC testing as compared to core lab testing

  Specificity, positive/negative predictive values will be derived

  3 months

Secondary Outcomes (1)

• Incidence in which decision making would have been altered by POC testing

  12 months

Other Outcomes (2)

• In hospital outcomes

  16 months

• Length of hospital admission

  16 months

Study Arms (4)

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

EXPERIMENTAL

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

Diagnostic Test: Spartan COVID-19 Platform

patients undergoing cardiac testing/procedures

EXPERIMENTAL

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

Diagnostic Test: Spartan COVID-19 Platform

patients awaiting surgery

EXPERIMENTAL

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

Diagnostic Test: Spartan COVID-19 Platform

Health Care Workers

EXPERIMENTAL

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

Diagnostic Test: Spartan COVID-19 Platform

Interventions

Spartan COVID-19 Platform DIAGNOSTIC_TEST

Nasal-pharyngeal swab for testing on the Spartan Covid-19 platform

Health Care Workers; Patients consulted upon by ICU, internal medicine, or cardiology for hospital admission; patients awaiting surgery; patients undergoing cardiac testing/procedures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a cohort study of participants falling into one of four groups.

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: February 23, 2021
• Study Start: March 19, 2021
• Primary Completion: May 31, 2021
• Study Completion: August 31, 2021
• Last Updated: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)