Trials / Unknown
UnknownNCT04352764
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
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 5,000 (estimated)
- Sponsor
- Texas Cardiac Arrhythmia Research Foundation · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2020-03-27
- Primary completion
- 2020-12-31
- Completion
- 2021-01-31
- First posted
- 2020-04-20
- Last updated
- 2020-04-27
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04352764. Inclusion in this directory is not an endorsement.