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

Overview

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

Full Title of Study: “A Prospective Cohort Study of Immunoglobulin G (IgG) Dynamics Against SARS-Co”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Other
  • Study Primary Completion Date: May 31, 2022

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

  • Other: SARS-CoV-2
    • Observational

Arms, Groups and Cohorts

  • Unvaccinated SARS-CoV-2 positive
    • Participants who have tested positive for SARS-CoV-2, both with and without symptoms, who have not been vaccinated
  • Vaccinated
    • Participants who were vaccinated against SARS-CoV-2

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Everly Health
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Timothy Bauer, PhD, Principal Investigator, Everly Health

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