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

NCT ID: NCT04767958

Last Updated: 2022-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-19

Study Completion Date

2021-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Covid19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

This is a cohort study of participants falling into one of four groups.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

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

Group Type EXPERIMENTAL

Spartan COVID-19 Platform

Intervention Type DIAGNOSTIC_TEST

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

patients undergoing cardiac testing/procedures

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

Group Type EXPERIMENTAL

Spartan COVID-19 Platform

Intervention Type DIAGNOSTIC_TEST

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

patients awaiting surgery

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

Group Type EXPERIMENTAL

Spartan COVID-19 Platform

Intervention Type DIAGNOSTIC_TEST

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

Health Care Workers

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

Group Type EXPERIMENTAL

Spartan COVID-19 Platform

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Spartan COVID-19 Platform

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20200858-01T

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

SARS-CoV-2 OTC At Home Test
NCT05553964 TERMINATED NA
Rapid, Onsite COVID-19 Detection
NCT04460690 COMPLETED NA
COVID-19 SARS-CoV-2 RAST Study
NCT06452056 COMPLETED