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

Primary Purpose

COVID-19

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
diagnostic tests for COVID-19 infection
Sponsored by
Texas Cardiac Arrhythmia Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for COVID-19

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Texas Cardiac Arrhythmia InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Viral RNA test using nasopharyngeal swab

Viral RNA test using sputum

Serology test using blood

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 29, 2020
Last Updated
August 7, 2020
Sponsor
Texas Cardiac Arrhythmia Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04372004
Brief Title
Comparison of the Efficacy of Rapid Tests to Identify COVID-19 Infection (CATCh COVID-19)
Acronym
CATCH COVID-19
Official Title
Comparison of the Efficacy of Rapid Tests to Identify COVID-19 Infection (CATCh COVID-19)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 8, 2020 (Actual)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Cardiac Arrhythmia Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Each subject will be tested using 3 different samples on two testing platforms (serology and viral-RNA detection)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Viral RNA test using nasopharyngeal swab
Arm Type
Active Comparator
Arm Title
Viral RNA test using sputum
Arm Type
Active Comparator
Arm Title
Serology test using blood
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
diagnostic tests for COVID-19 infection
Intervention Description
Compare the efficacy of diagnostic tests for COVID-19 infection in detecting antibodies and viral-RNA
Primary Outcome Measure Information:
Title
detection of viral infection using serology and viral-RNA detection kits
Description
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
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Temporal trend of antibodies in blood
Description
Temporal trend of the IgM and IgG production in response to the infection by conducting serial serology tests at bi-weekly interval
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MITRA Mohanty, MD
Phone
5127842651
Email
mitra1989@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Deb Cardinal, RN MBA
Phone
512) 807-3150
Facility Information:
Facility Name
Texas Cardiac Arrhythmia Institute
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mitra Mohanty, MD
Phone
512-544-8186
Email
mitra1989@gmail.com
First Name & Middle Initial & Last Name & Degree
Angel Mayedo, MD
Phone
5125447254

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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