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OpenTrials
Completed

NCT Number: NCT05042193

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

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

Completed

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Key information

Conditions

SARS-CoV-2 Acute Respiratory Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Everlywell, Inc

Austin, Texas, 78703, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SARS-CoV-2

Other

Observational

Primary outcomes

  1. 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

  1. 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

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

    Time frame: Up to 9 months

Sponsors and collaborators

Lead sponsor

Everly Health

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 13, 2021
Registry last updated
Jun 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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