Comparison of the Efficacy of Rapid Tests to Identify COVID-19 Infection (CATCh COVID-19)
Purpose
This study is designed to compare the efficacy of detection of COVID-19 infection using the serology test in blood sample and the PCR-based test in the nasopharyngeal (NP) and sputum sample. Furthermore, it aims to evaluate the temporal trend of appearance of IgM and IgG in blood.
Condition
- COVID-19
Eligibility
- Eligible Ages
- Between 18 Years and 85 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- • Male or female over 18 years of age at the time of enrollment - Current symptoms of COVID-19 ; fever alone or fever and at least one of the following symptoms need to be present - Dry cough - Sore throat - Shortness of breath - Chills - Muscle pain - Headache - New loss of taste or smell - Chills with repeated shaking
Exclusion Criteria
- • Unwilling to provide informed consent - Unwilling to undergo bi-weekly serological test during the 1-month enrollment
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Each subject will be tested using 3 different samples on two testing platforms (serology and viral-RNA detection)
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Active Comparator Viral RNA test using nasopharyngeal swab |
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Active Comparator Viral RNA test using sputum |
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Active Comparator Serology test using blood |
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Recruiting Locations
Texas Cardiac Arrhythmia Institute
Austin, Texas 78705
Austin, Texas 78705
More Details
- NCT ID
- NCT04372004
- Status
- Unknown status
- Sponsor
- Texas Cardiac Arrhythmia Research Foundation
Detailed Description
The investigators hypothesize that viral-RNA test using sputum will be equally efficient as the test performed in NP swab. Moreover, the serology test and the PCR-based test will be comparable in efficacy for detection of infection