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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