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NCT05042193 Clinical Trial

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

SARS-CoV-2 Acute Respiratory Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05042193
Other study ID # EW-US-4010-0007
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 19, 2021
Est. completion date June 14, 2022

Study information
Verified date June 2022
Source Everly Health
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 1883
Est. completion date June 14, 2022
Est. primary completion date May 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• SARS-CoV-2
Observational

Locations
Country Name City State
United States Everlywell, Inc Austin Texas

Sponsors (1)
Lead Sponsor Collaborator
Everly Health

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary To compare the off-kinetics of IgG positivity against SARS-CoV-2 by natural infection vs vaccination Up to 9 months
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