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

Sponsor

Everly Health (Industry)

Overall Status

Completed

CT.gov ID

NCT05042193

Collaborator

(none)

1,883

Enrollment

Location

14.9

Actual Duration (Months)

126.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV-2 Acute Respiratory Disease	Other: SARS-CoV-2

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 Design

Study Type:

Observational

Actual Enrollment :

1883 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Mar 19, 2021

Actual Primary Completion Date :

May 31, 2022

Actual Study Completion Date :

Jun 14, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Everlywell, Inc	Austin	Texas	United States	78703

Sponsors and Collaborators

Everly Health

Investigators

Principal Investigator: Timothy Bauer, PhD, Everly Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Everly Health

ClinicalTrials.gov Identifier:

NCT05042193

Other Study ID Numbers:

EW-US-4010-0007

First Posted:

Sep 13, 2021

Last Update Posted:

Jun 15, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Respiration Disorders

Respiratory Tract Diseases

Study Results

No Results Posted as of Jun 15, 2022