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

NCT ID: NCT05042193

Last Updated: 2022-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1883 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-19

Study Completion Date

2022-06-14

Brief Summary

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

Detailed Description

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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.

Conditions

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SARS-CoV-2 Acute Respiratory Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Unvaccinated SARS-CoV-2 positive

Participants who have tested positive for SARS-CoV-2, both with and without symptoms, who have not been vaccinated

SARS-CoV-2

Intervention Type OTHER

Observational

Vaccinated

Participants who were vaccinated against SARS-CoV-2

SARS-CoV-2

Intervention Type OTHER

Observational

Interventions

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SARS-CoV-2

Observational

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Everly Health

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Timothy Bauer, PhD

Role: PRINCIPAL_INVESTIGATOR

Everly Health

Locations

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Everlywell, Inc

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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EW-US-4010-0007

Identifier Type: -

Identifier Source: org_study_id

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