Comparison of the Efficacy of Rapid Tests to Identify COVID-19 Infection (CATCh COVID-19)

Phase 1

• Conditions: COVID-19
• Interventions: Diagnostic Test: diagnostic tests for COVID-19 infection

• Registration Number: NCT04372004
• Lead Sponsor: Texas Cardiac Arrhythmia Research Foundation

Brief Summary

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.

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

Study Timeline

• Study First Submitted: 2020-04-29
• Study First Submitted QC: 2020-04-29
• Status Verified: 2020-05
• Study First Posted: 2020-05-01
• Study Start: 2020-05-08
• Last Update Submitted: 2020-08-07
• Last Update Posted: 2020-08-11
• Primary Completion: 2021-05
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Viral RNA test using sputum	diagnostic tests for COVID-19 infection	-
Viral RNA test using nasopharyngeal swab	diagnostic tests for COVID-19 infection	-
Serology test using blood	diagnostic tests for COVID-19 infection	-

Primary Outcome Measures

Name	Time	Method
detection of viral infection using serology and viral-RNA detection kits	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 Outcome Measures

Name	Time	Method
Temporal trend of antibodies in blood	1 month	Temporal trend of the IgM and IgG production in response to the infection by conducting serial serology tests at bi-weekly interval

Trial Locations

Locations (1)

Texas Cardiac Arrhythmia Institute; 🇺🇸 Austin, Texas, United States