Recruiting
Phase 1

Rapid Tests

Sponsor:

Texas Cardiac Arrhythmia Research Foundation

Code:

NCT04372004

Conditions

COVID-19

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

diagnostic tests for COVID-19 infection

Study Details

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

Study ID

NCT04372004

Start date

May 8, 2020

Status verified date

May, 2020

Completion date

Jun, 2021

Anticipated

Primary completion date

May, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Viral RNA test using nasopharyngeal swab

active comparator: Viral RNA test using sputum

active comparator: Serology test using blood

Interventions

diagnostic tests for COVID-19 infection

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

Primary outcome measure

  • detection of viral infection using serology and viral-RNA detection kits [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

MITRA Mohanty, MD

5127842651mitra1989@gmail.com

Deb Cardinal, RN MBA

512) 807-3150

Locations

Texas Cardiac Arrhythmia Institute

Recruiting

Austin, Texas, United States, 78705

Contacts

Mitra Mohanty, MD

512-544-8186mitra1989@gmail.com

Angel Mayedo, MD

5125447254

More Information

Sponsor

Texas Cardiac Arrhythmia Research Foundation

Last update posted

Aug 11, 2020

Last verified

May, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Texas Cardiac Arrhythmia Research Foundation on 2020-08-11.