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

NCT04372004 | Unknown Phase 1 FDA Drug

• 1 other identifier: TCAI_CATCH COVID-19
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Temporal trend of antibodies in blood

  1 month

Study Arms (3)

Viral RNA test using nasopharyngeal swab

ACTIVE COMPARATOR

Diagnostic Test: diagnostic tests for COVID-19 infection

Viral RNA test using sputum

ACTIVE COMPARATOR

Diagnostic Test: diagnostic tests for COVID-19 infection

Serology test using blood

ACTIVE COMPARATOR

Diagnostic Test: diagnostic tests for COVID-19 infection

Interventions

diagnostic tests for COVID-19 infection DIAGNOSTIC_TEST

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

Serology test using blood; Viral RNA test using nasopharyngeal swab; Viral RNA test using sputum

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unwilling to provide informed consent
• Unwilling to undergo bi-weekly serological test during the 1-month enrollment

Sponsors & Collaborators

• Texas Cardiac Arrhythmia Research Foundation: lead

Study Sites (1)

Texas Cardiac Arrhythmia Institute

Austin, Texas, 78705, United States

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Diagnostic Tests, Routine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

MITRA Mohanty, MD

CONTACT

5127842651; mitra1989@gmail.com

Deb Cardinal, RN MBA

CONTACT

512) 807-3150

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Medical Director

Model Details: Each subject will be tested using 3 different samples on two testing platforms (serology and viral-RNA detection)

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 1, 2020
• Study Start: May 8, 2020
• Primary Completion: May 1, 2021
• Study Completion: June 1, 2021
• Last Updated: August 11, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)