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

Texas Cardiac Arrhythmia Research Foundation

Status and phase: Unknown; Phase 1

Conditions: COVID-19

Treatments: Diagnostic Test: diagnostic tests for COVID-19 infection

Study type: Interventional

Funder types: Other

Identifiers

NCT04372004

TCAI_CATCH COVID-19

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Viral RNA test using nasopharyngeal swab

Active Comparator group

Treatment:

Diagnostic Test: diagnostic tests for COVID-19 infection

Viral RNA test using sputum

Active Comparator group

Treatment:

Diagnostic Test: diagnostic tests for COVID-19 infection

Serology test using blood

Active Comparator group

Treatment:

Diagnostic Test: diagnostic tests for COVID-19 infection