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

COVID-19 Clinical Trial

— CATCH COVID-19  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04372004
• Other study ID #: TCAI_CATCH COVID-19
• Status: Recruiting
• Phase: Phase 1
• Start date: May 8, 2020
• Est. completion date: June 2021

Study information

• Verified date: May 2020
• Source: Texas Cardiac Arrhythmia Research Foundation
• Contact: MITRA Mohanty, MD
• Phone: 5127842651
• Email: mitra1989[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Infection

Intervention

Diagnostic Test:
• diagnostic tests for COVID-19 infection
Compare the efficacy of diagnostic tests for COVID-19 infection in detecting antibodies and viral-RNA

Locations

Country	Name	City	State
United States	Texas Cardiac Arrhythmia Institute	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Cardiac Arrhythmia Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	detection of viral infection using serology and viral-RNA detection kits	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	1 day
Secondary	Temporal trend of antibodies in blood	Temporal trend of the IgM and IgG production in response to the infection by conducting serial serology tests at bi-weekly interval	1 month