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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

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

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Texas Cardiac Arrhythmia Institute
Austin, Texas 78705
Contact:
Mitra Mohanty, MD
512-544-8186
mitra1989@gmail.com

More Details

NCT ID
NCT04372004
Status
Unknown status
Sponsor
Texas Cardiac Arrhythmia Research Foundation

Study Contact

MITRA Mohanty, MD
5127842651
mitra1989@gmail.com

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.