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

ArmDescriptionAssigned Intervention
Active Comparator
Viral RNA test using nasopharyngeal swab
  • Diagnostic Test: diagnostic tests for COVID-19 infection
    Compare the efficacy of diagnostic tests for COVID-19 infection in detecting antibodies and viral-RNA
Active Comparator
Viral RNA test using sputum
  • Diagnostic Test: diagnostic tests for COVID-19 infection
    Compare the efficacy of diagnostic tests for COVID-19 infection in detecting antibodies and viral-RNA
Active Comparator
Serology test using blood
  • Diagnostic Test: diagnostic tests for COVID-19 infection
    Compare the efficacy of diagnostic tests for COVID-19 infection in detecting antibodies and viral-RNA

Recruiting Locations

Texas Cardiac Arrhythmia Institute
Austin, Texas 78705
Contact:
Mitra Mohanty, MD
512-544-8186
mitra1989@gmail.com

More Details

NCT ID
NCT04372004
Status
Unknown status
Sponsor
Texas Cardiac Arrhythmia Research Foundation

Study Contact

MITRA Mohanty, MD
5127842651
mitra1989@gmail.com

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