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

Everly Health

Status: Completed

Conditions: SARS-CoV-2 Acute Respiratory Disease

Treatments: Other: SARS-CoV-2

Study type: Observational

Funder types: Industry

Identifiers

NCT05042193

EW-US-4010-0007

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,883 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,883 participants in 2 patient groups

Unvaccinated SARS-CoV-2 positive

Description:

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

Treatment:

Other: SARS-CoV-2

Vaccinated

Description:

Participants who were vaccinated against SARS-CoV-2

Treatment:

Other: SARS-CoV-2