ANTIBODY BASED TESTS FOR SARSCoV-2 COVID-19) - Evaluation of Patients and Healthcare Providers in the Confines of Healthcare Settings

Covid19 Clinical Trial

Official title:

Use of the ANTIBODY BASED LATERAL FLOW IMMUNOASSAY TESTS FOR SARSCoV-2 THAT CAUSES CORONAVIRUS DISEASE 2019 (COVID-19) - Evaluation of Patients and Healthcare Providers in the Confines of Healthcare Settings

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04352764
• Other study ID #: TCAI_COVID-19
• Status: Recruiting
• Start date: March 27, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: April 2020
• Source: Texas Cardiac Arrhythmia Research Foundation
• Contact: Andrea Natale, MD
• Phone: 512-544-8186
• Email: dr.natale[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study will be conducted as a registry to identify asymptomatic or symptomatic persons to determine whether they carry SARS-CoV-2 antibodies.

Description:

This study will be conducted as a registry to identify asymptomatic or symptomatic persons to determine whether they carry SARS-CoV-2 antibodies. The blood test data will be collected as allowed by the EUA using the CoronaCideTM COVID-19 IgM/IgG Rapid Test and the Premier Biotech COVID-19 IgM/IgG Rapid Test. Both COVID-19 IgM/IgG Rapid Tests are intended for Over-The-Counter/Professional use as a screening aid in the diagnosis of primary and secondary SARSCoV-2 infections, and are only for use under the FDA's EUA.

The RNA test data will be collected via a nasopharyngeal swab and processed using the Abbott ID NOW COVID-19 diagnostic test.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: January 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patient is Under the care of Texas Cardiac Arrhythmia, and Presenting to the hospital OR Presenting to a clinic conducted by Texas Cardiac Arrhythmia Or

• An employee of Texas Cardiac Arrhythmia Or

• An employee or healthcare professional working with patients receiving cardiac electrophysiology care at a hospital. Or A professional first responder to include Emergency Medical Services (EMS), Police or Fire departments.

Exclusion Criteria:

• Any person who refuses to undergo study procedures

Related Conditions & MeSH terms

• Covid19

Intervention

Diagnostic Test:
• CoronaCideTM COVID-19 IgM/IgG Rapid Test and Premier Biotech COVID-19 IgM/IgG Rapid Test
The tests are being distributed under section IV.D of the current United States Food and Drug Administration (FDA) policies for diagnostic tests for coronavirus disease 2019. The test is available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Service's (HHS's) declaration that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes COVID-19

Locations

Country	Name	City	State
United States	St. David's Medical Center	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Cardiac Arrhythmia Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of COVID-19 exposure	To evaluate the prevalence of COVID-19 exposure to healthcare staff, community 1st responders and patients. and patient population within a subspecialty	Mar-Dec 2020
Secondary	correlation between the test results with the presence or lack of COVID-19 symptoms or illness	correlation between the test results with the presence or lack of COVID-19 symptoms or illness	Mar-Dec 2020
Secondary	correlate pre-existing risk factors with test results and baseline symptoms	correlate pre-existing risk factors with test results and baseline symptoms	Mar-Dec 2020
Secondary	correlate subsequent healthcare utilization with test results and baseline symptoms	correlate subsequent healthcare utilization with test results and baseline symptoms	Mar-Dec 2020