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

Completed

• Conditions: SARS-CoV-2 Acute Respiratory Disease
• Interventions: Other: SARS-CoV-2

• Registration Number: NCT05042193
• Lead Sponsor: Everly Health

Brief Summary

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

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 Timeline

• Study Start: 2021-03-19
• Study First Submitted: 2021-09-09
• Study First Submitted QC: 2021-09-09
• Study First Posted: 2021-09-13
• Primary Completion: 2022-05-31
• Status Verified: 2022-06
• Study Completion: 2022-06-14
• Last Update Submitted: 2022-06-14
• Last Update Posted: 2022-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1883

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
To compare the off-kinetics of IgG positivity against SARS-CoV-2 by natural infection vs vaccination	Up to 9 months

Trial Locations

Locations (1)

Everlywell, Inc; 🇺🇸 Austin, Texas, United States