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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04372004

Acronym

CATCH COVID-19

Enrollment

100

Registered

2020-05-01

Start date

2020-05-08

Completion date

2021-06-30

Last updated

2020-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

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

Interventions

DIAGNOSTIC_TESTdiagnostic tests for COVID-19 infection

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
detection of viral infection using serology and viral-RNA detection kits	1 day	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

Measure	Time frame	Description
Temporal trend of antibodies in blood	1 month	Temporal trend of the IgM and IgG production in response to the infection by conducting serial serology tests at bi-weekly interval

Countries

United States

Contacts

Primary ContactMITRA Mohanty, MD

mitra1989@gmail.com5127842651

Backup ContactDeb Cardinal, RN MBA

512) 807-3150

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026