Clinical Evaluation of a Point-of-Care (POC), COVID-19 Rapid Antigen Test (CoviDx™)
NCT ID: NCT04750629
Last Updated: 2021-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
140 participants
OBSERVATIONAL
2021-02-08
2021-05-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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SARS-Cov-2 RT-PCR AND CoviDx Rapid Antigen Testing
Sequentially enrolled symptomatic patients who present for COVID-19 testing and have a swab collected for high-sensitive, SARS-CoV-2 RT-PCR testing per Standard of Care AND a swab for CoviDx™ Rapid Antigen testing.
POC CoviDx™ Rapid Antigen Test
All patients will have a nasal swab for CoviDx™ Rapid Antigen testing
Interventions
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POC CoviDx™ Rapid Antigen Test
All patients will have a nasal swab for CoviDx™ Rapid Antigen testing
Eligibility Criteria
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Inclusion Criteria
* First onset of COVID-19-like symptoms within the last 5 days
* ≥ 1 year of age
* Signed Informed Consent
Exclusion Criteria
* Less than 1 year of age
* SARS-Cov-2 RT-PCR collection that occurred \> 3 hours from CoviDx Rapid Antigen Swab collection
* First onset of COVID-19-like symptoms occurring more than 5 days from study visit
* Invalid or missing PCR test results
* Use of a non-high-sensitive SARS-CoV-2 test as the qualifying SARS-CoV-2 RT-PCR test (e.g., Abbott ID NOW, rapid antigen tests, tests that do not have FDA EUA, a test that was not approved by Sponsor for use in the study)
* Enrollment in another study involving the collection of a nasopharyngeal or nasal swab
* Receipt of a COVID-19 vaccine or participation in a COVID-19 vaccine study
1 Year
ALL
No
Sponsors
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Rapid Pathogen Screening
INDUSTRY
Lumos Diagnostics
INDUSTRY
Responsible Party
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Locations
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Doral Medical Research
Hialeah, Florida, United States
Comprehensive Clinical Research
West Palm Beach, Florida, United States
Countries
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Other Identifiers
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21 0115
Identifier Type: -
Identifier Source: org_study_id
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