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

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

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

Study Overview

• Status: Unknown
• Conditions: Covid19
• Intervention / Treatment: Diagnostic test: CoronaCideTM COVID-19 IgM/IgG Rapid Test and Premier Biotech COVID-19 IgM/IgG Rapid Test

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78705
      • Recruiting
      • St. David's Medical Center
      • Contact: Deb Cardinal, RN; Phone Number: 512-431-4868
      • Contact: Andrea Natale, MD FACC FHRS; Email: dr.natale@gmail.com
      • Principal Investigator: Andrea Natale, MD FACC FHRS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patient under care of TCA or employee of TCA or employee or healthcare professional working with patients receiving cardiac electrophysiology care at a hospital

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
correlate subsequent healthcare utilization with test results and baseline symptoms	correlate subsequent healthcare utilization with test results and baseline symptoms	Mar-Dec 2020

Collaborators and Investigators

• Sponsor: Texas Cardiac Arrhythmia Research Foundation

Publications and helpful links

General Publications

• Mohanty S, Lakkireddy D, Trivedi C, MacDonald B, Quintero Mayedo A, Della Rocca DG, Atkins D, Park P, Shah A, Gopinathannair R, Al-Ahmad A, Burkhardt JD, Gallinghouse GJ, Bassiouny M, Di Biase L, Kessler D, Tschopp D, Coffeen P, Horton R, Canby R, Natale A. Creating a safe workplace by universal testing of SARS-CoV-2 infection in asymptomatic patients and healthcare workers in the electrophysiology units: a multi-center experience. J Interv Card Electrophysiol. 2021 Oct;62(1):171-176. doi: 10.1007/s10840-020-00886-9. Epub 2020 Oct 1.

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2020
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): January 31, 2021

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (Actual): April 20, 2020

Study Record Updates

• Last Update Posted (Actual): April 27, 2020
• Last Update Submitted That Met QC Criteria: April 23, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: TCAI_COVID-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: No plans decided yet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No