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

June 14, 2022 updated by: Everly Health

A Prospective Cohort Study of Immunoglobulin G (IgG) Dynamics Against SARS-Co

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1883

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78703
        • Everlywell, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants who have tested positive for SARS-CoV-2 by either RT-PCR or Antigen test for COVID-19 or have received one of the commercially available SARS-CoV-2 vaccines.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Unvaccinated SARS-CoV-2 positive
Participants who have tested positive for SARS-CoV-2, both with and without symptoms, who have not been vaccinated
Other: SARS-CoV-2
Observational
Vaccinated
Participants who were vaccinated against SARS-CoV-2
Other: SARS-CoV-2
Observational

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: Up to 9 months
Up to 9 months

Secondary Outcome Measures

Outcome 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
Time Frame: Up to 9 months
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
Up to 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Everly Health

Investigators

  • Principal Investigator: Timothy Bauer, PhD, Everly Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2021

Primary Completion (Actual)

May 31, 2022

Study Completion (Actual)

June 14, 2022

Study Registration Dates

First Submitted

September 9, 2021

First Submitted That Met QC Criteria

September 9, 2021

First Posted (Actual)

September 13, 2021

Study Record Updates

Last Update Posted (Actual)

June 15, 2022

Last Update Submitted That Met QC Criteria

June 14, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EW-US-4010-0007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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