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

• Conditions: Covid19

• Registration Number: NCT04352764
• Lead Sponsor: Texas Cardiac Arrhythmia Research Foundation

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.

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 Timeline

• Study Start: 2020-03-27
• Status Verified: 2020-04
• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-04-16
• Study First Posted: 2020-04-20
• Last Update Submitted: 2020-04-23
• Last Update Posted: 2020-04-27
• Primary Completion: 2020-12-31
• Study Completion: 2021-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
prevalence of COVID-19 exposure	Mar-Dec 2020	To evaluate the prevalence of COVID-19 exposure to healthcare staff, community 1st responders and patients. and patient population within a subspecialty

Secondary Outcome Measures

Name	Time	Method
correlate subsequent healthcare utilization with test results and baseline symptoms	Mar-Dec 2020	correlate subsequent healthcare utilization with test results and baseline symptoms
correlate pre-existing risk factors with test results and baseline symptoms	Mar-Dec 2020	correlate pre-existing risk factors with test results and baseline symptoms
correlation between the test results with the presence or lack of COVID-19 symptoms or illness	Mar-Dec 2020	correlation between the test results with the presence or lack of COVID-19 symptoms or illness

Trial Locations

Locations (1)

St. David's Medical Center; 🇺🇸 Austin, Texas, United States