ANTIBODY BASED TESTS FOR SARSCoV-2 COVID-19) - Evaluation of Patients and Healthcare Providers in the Confines of Healthcare Settings
NCT04352764 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 5000
Last updated 2020-04-27
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
Interventions
- DIAGNOSTIC_TEST
-
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
Sponsors & Collaborators
-
Texas Cardiac Arrhythmia Research Foundation
lead OTHER
Eligibility
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-03-27
- Primary Completion
- 2020-12-31
- Completion
- 2021-01-31
Countries
- United States
Study Locations
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