Comparison of the Efficacy of Rapid Tests to Identify COVID-19 Infection (CATCh COVID-19)
Overview
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.
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Diagnostic
- Masking: None (Open Label)
- Study Primary Completion Date: May 2021
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
Interventions
- Diagnostic Test: diagnostic tests for COVID-19 infection
- Compare the efficacy of diagnostic tests for COVID-19 infection in detecting antibodies and viral-RNA
Arms, Groups and Cohorts
- Active Comparator: Viral RNA test using nasopharyngeal swab
- Active Comparator: Viral RNA test using sputum
- Active Comparator: Serology test using blood
Clinical Trial Outcome Measures
Primary Measures
- detection of viral infection using serology and viral-RNA detection kits
- Time Frame: 1 day
- Detection of viral infection in the two test platforms using 3 specimen (blood, nasal swab and sputum) from the same subject, in detecting COVID-19 infection
Secondary Measures
- Temporal trend of antibodies in blood
- Time Frame: 1 month
- Temporal trend of the IgM and IgG production in response to the infection by conducting serial serology tests at bi-weekly interval
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 85 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Texas Cardiac Arrhythmia Research Foundation
- Provider of Information About this Clinical Study
- Principal Investigator: Andrea Natale, Executive Medical Director – Texas Cardiac Arrhythmia Research Foundation
- Overall Contact(s)
- MITRA Mohanty, MD, 5127842651, mitra1989@gmail.com
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