NCT05042193CompletedNot Applicable
A Prospective Cohort Study of Immunoglobulin G (IgG) Dynamics Against SARS-Co
Everly Health1 site in 1 country1,883 target enrollmentStarted: March 19, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,883
- Locations
- 1
- Primary Endpoint
- To describe the longevity and seroprevalence of IgG against SARS-CoV-2 in a cohort of individuals exposed to SARS-CoV-2
Study Overview
Brief Summary
The primary objective of this study is to describe the longevity of IgG against SARS-CoV-2 infection or vaccination.
Detailed Description
This virtual clinical study will use a prospective design, to evaluate longevity and seroprevalence of IgG against SARS-CoV-2 in approximately 800 patients as measured by Dried Blood Spots via fingerstick using the Everlywell COVID-19 Antibody Test Home Collection Kit. Participants will be followed up to 9 months at 1, 3, 6 and 9 months after enrollment.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age ≥ 18 years
- •Willing to provide informed consent prior to participation.
- •Cohort 1 (Arm 1) - Positive test results for SARS-CoV-2 virus by an RT-PCR or Antigen test AND not received any COVID-19 vaccine or participated in any COVID-19 vaccine trial
- •Cohort 2 (Arm 2) - Received the COVID-19 vaccine
Exclusion Criteria
- •Unable or unwilling to provide informed consent
- •Individuals with known conditions or treatments associated with immune impairment, such as cancer and chemotherapy
Outcomes
Primary Outcomes
To describe the longevity and seroprevalence of IgG against SARS-CoV-2 in a cohort of individuals exposed to SARS-CoV-2
Time Frame: Up to 9 months
Secondary Outcomes
- To compare the off-kinetics of IgG positivity against SARS-CoV-2, stratified by age, sex, race, ethnicity, infection symptomaticity, initial viral load(Up to 9 months)
- To compare the off-kinetics of IgG positivity against SARS-CoV-2 by natural infection vs vaccination(Up to 9 months)
Investigators
Study Sites (1)
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