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

NCT ID: NCT04372004

Last Updated: 2020-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-08

Study Completion Date

2021-06-30

Brief Summary

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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

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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

Conditions

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COVID-19

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Each subject will be tested using 3 different samples on two testing platforms (serology and viral-RNA detection)
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Viral RNA test using nasopharyngeal swab

Group Type ACTIVE_COMPARATOR

diagnostic tests for COVID-19 infection

Intervention Type DIAGNOSTIC_TEST

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

Viral RNA test using sputum

Group Type ACTIVE_COMPARATOR

diagnostic tests for COVID-19 infection

Intervention Type DIAGNOSTIC_TEST

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

Serology test using blood

Group Type ACTIVE_COMPARATOR

diagnostic tests for COVID-19 infection

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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diagnostic tests for COVID-19 infection

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Texas Cardiac Arrhythmia Research Foundation

OTHER

Sponsor Role lead

Responsible Party

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Andrea Natale

Executive Medical Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Texas Cardiac Arrhythmia Institute

Austin, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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MITRA Mohanty, MD

Role: CONTACT

5127842651

Deb Cardinal, RN MBA

Role: CONTACT

512) 807-3150

Facility Contacts

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Mitra Mohanty, MD

Role: primary

512-544-8186

Angel Mayedo, MD

Role: backup

5125447254

Other Identifiers

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TCAI_CATCH COVID-19

Identifier Type: -

Identifier Source: org_study_id

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