COVID-19 Immunity Assessment
Blood Specimen Collection for COVID-19 Immunity Assessment Mailer Kit Clinical Study
1 other identifier
observational
662
1 country
1
Brief Summary
The purpose of this study is to collect blood specimens from individuals post infection or post vaccination over time to assess COVID19 Immunity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 10, 2021
CompletedFirst Submitted
Initial submission to the registry
October 13, 2021
CompletedFirst Posted
Study publicly available on registry
October 15, 2021
CompletedAugust 14, 2023
August 1, 2023
2 months
October 13, 2021
August 8, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Neutralizing Antibody Levels
Measuring neutralizing antibody levels with COVID-19 immunity assessment test
3 months
Study Arms (3)
COVID-19 Vaccinated Individuals
Males and females, 13years old and above, vaccinated for COVID-19
Previously positive for COVID-19 and unvaccinated individuals
Males and females, 13years old and above, unvaccinated for COVID-19 and previously tested positive for COVID-19.
No previous COVID infection or vaccination
Males and females, 13years old and above, unvaccinated for COVID-19 and previously not tested positive for COVID-19.
Eligibility 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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
DxTerity Diagnostics Inc.
Compton, California, 90220, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2021
First Posted
October 15, 2021
Study Start
July 15, 2021
Primary Completion
September 10, 2021
Study Completion
September 10, 2021
Last Updated
August 14, 2023
Record last verified: 2023-08