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NCT05080231 Clinical Trial

COVID-19 Immunity Assessment

COVID-19 Clinical Trial

Official title:
Blood Specimen Collection for COVID-19 Immunity Assessment Mailer Kit Clinical Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05080231
Other study ID # PROT-0239
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 15, 2021
Est. completion date September 10, 2021

Study information
Verified date August 2023
Source DxTerity Diagnostics
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to collect blood specimens from individuals post infection or post vaccination over time to assess COVID19 Immunity.

Description:

The DxTerity COVID-19 Immunity Assessment Collection Mailer Kit contains the DxCollect MicroCollection Device (MCD) Serology fingerstick blood collection device packaged as a home collection kit, designed for collection and shipment of fingerstick blood back to DxTerity CLIA (Clinical Laboratory Improvements Amendment) certified laboratory for testing. The clinical performance of the collection device for use with anti-SARS-CoV-2 antibody tests will be evaluated for use with cPASS™ anti-SARS-CoV-2 neutralizing antibody detection kit (EUA 201427). The samples may also be used for assessing immunity or protection post COVID-19 vaccination.

Recruitment information / eligibility
Status Completed
Enrollment 662
Est. completion date September 10, 2021
Est. primary completion date September 10, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 13 Years and older
Eligibility Inclusion Criteria: - Males and females =13 years old. - Not vaccinated and were previously positive for COVID-19 OR are vaccinated for COVID-19. - Provides test report to demonstrate prior COVID-19 positive result (only applicable to unvaccinated subjects who were previously positive for COVID-19, not applicable for COVID-19 vaccinated subjects). - Provides informed consent and completed questionnaire. - Able to register the collection kit on the DxTerity portal. - Able to collect and ship blood samples back to DxTerity. Exclusion Criteria: - Unable to provide COVID-19 positive test report (only applicable to unvaccinated subjects who were previously positive for COVID-19, not applicable for COVID-19 vaccinated subjects). - Unable to complete informed consent and/or questionnaire. - Unable to complete the study activities in a timely manner.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States DxTerity Diagnostics Inc. Compton California

Sponsors (1)
Lead Sponsor Collaborator
DxTerity Diagnostics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Neutralizing Antibody Levels Measuring neutralizing antibody levels with COVID-19 immunity assessment test 3 months
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