Clinical trial NCT04352764: ANTIBODY BASED TESTS FOR SARSCoV-2 COVID-19) - Evaluation of Patients and Healthcare Providers in the Confines of Healthcare Settings
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Lead sponsor: Texas Cardiac Arrhythmia Research Foundation
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: prevalence of COVID-19 exposure
timeFrame: Mar-Dec 2020
Secondary outcomes:
measure: correlation between the test results with the presence or lack of COVID-19 symptoms or illness
timeFrame: Mar-Dec 2020
measure: correlate pre-existing risk factors with test results and baseline symptoms
timeFrame: Mar-Dec 2020
measure: correlate subsequent healthcare utilization with test results and baseline symptoms
timeFrame: Mar-Dec 2020
Other outcomes:
Locations:
city: Austin
country: United States
facility: St. David's Medical Center
state: Texas
Study officials:
References:
citation: 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.