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
1 other identifier
observational
5,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 27, 2020
CompletedFirst Submitted
Initial submission to the registry
April 16, 2020
CompletedFirst Posted
Study publicly available on registry
April 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2021
CompletedApril 27, 2020
April 1, 2020
9 months
April 16, 2020
April 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Mar-Dec 2020
correlate subsequent healthcare utilization with test results and baseline symptoms
Mar-Dec 2020
Interventions
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
Eligibility Criteria
Patient under care of TCA or employee of TCA or employee or healthcare professional working with patients receiving cardiac electrophysiology care at a hospital
You may qualify if:
- 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.
You may not qualify if:
- Any person who refuses to undergo study procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. David's Medical Center
Austin, Texas, 78705, United States
Related Publications (1)
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.
PMID: 33006086DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Month
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2020
First Posted
April 20, 2020
Study Start
March 27, 2020
Primary Completion
December 31, 2020
Study Completion
January 31, 2021
Last Updated
April 27, 2020
Record last verified: 2020-04