Recruiting

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

Sponsor:

Texas Cardiac Arrhythmia Research Foundation

Code:

NCT04352764

Conditions

Covid19

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

CoronaCideTM COVID-19 IgM/IgG Rapid Test and Premier Biotech COVID-19 IgM/IgG Rapid Test

Study Details

Brief summary:

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

Conditions

Covid19

Study ID

NCT04352764

Start date

Mar 27, 2020

Status verified date

Apr, 2020

Completion date

Jan 31, 2021

Anticipated

Primary completion date

Dec 31, 2020

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Interventions

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

Primary outcome measure

prevalence of COVID-19 exposure [ Time Frame: Mar-Dec 2020 ]

Central Contacts and Locations

Central contacts

Andrea Natale, MD

512-544-8186 dr.natale@gmail.com

Deb Cardinal, RN

512-431-4868

Locations

St. David's Medical Center

Recruiting

Austin, Texas, United States, 78705

Contacts

Andrea Natale, MD FACC FHRS

dr.natale@gmail.com

Deb Cardinal, RN

512-431-4868

Principal Investigator:

Andrea Natale, MD FACC FHRS

More Information

Sponsor

Texas Cardiac Arrhythmia Research Foundation

Last update posted

Apr 27, 2020

Last verified

Apr, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Texas Cardiac Arrhythmia Research Foundation on 2020-04-27.