A Prospective Virtual Study to Evaluate the Longevity of IgG Antibodies in Individuals Exposed to COVID-19

Everly Health1,883 enrolled

Overview

The primary objective of this study is to describe the longevity of IgG against SARS-CoV-2 infection or vaccination.

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 Type

OBSERVATIONAL

Enrollment

1,883

Conditions

SARS-CoV-2 Acute Respiratory Disease

Interventions

SARS-CoV-2OTHER

Observational

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Everlywell, Inc

Austin, Texas, United States

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

Time frame: Up to 9 months

To compare the off-kinetics of IgG positivity against SARS-CoV-2 by natural infection vs vaccination

Time frame: Up to 9 months

Data from ClinicalTrials.gov

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