SARS-CoV-2 Acute Respiratory Disease
Conditions
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.
Interventions
OTHERSARS-CoV-2
Observational
Sponsors
Everly Health
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To describe the longevity and seroprevalence of IgG against SARS-CoV-2 in a cohort of individuals exposed to SARS-CoV-2 | Up to 9 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed