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

August 7, 2020 updated by: Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Texas Cardiac Arrhythmia Institute
        • Contact:
        • Contact:
          • Angel Mayedo, MD
          • Phone Number: 5125447254

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas Cardiac Arrhythmia Research Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2020

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

April 29, 2020

First Submitted That Met QC Criteria

April 29, 2020

First Posted (Actual)

May 1, 2020

Study Record Updates

Last Update Posted (Actual)

August 11, 2020

Last Update Submitted That Met QC Criteria

August 7, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCAI_CATCH COVID-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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