Sustained Immunity to COVID-19 as Measured by SARS-CoV-2 Serology Assays

Henry Ford Health

Status: Completed

Conditions: Covid19

Treatments: Diagnostic Test: Serologic immunoassays to SARS-CoV-2 antibodies

Study type: Observational

Funder types: Other

Identifiers

NCT04562285

13978

Details and patient eligibility

About

The primary objective is to assess the ability of COVID-19 IgG and IgM assays to detect an immune response in COVID-19 patients in the Henry Ford Health System (HFHS), both during hospitalization and over the following 12 months.

Full description

The design strategy for this study is to validate the detection of COVID-19 antibodies in subjects at HFHS who test positive with RT-PCR for SARS-CoV-2 using fully automated test systems already in the core automated laboratory at HFH. This is a study of the immune response and kidney health of subjects who have recovered from COVID-19 infection.

There are 4 aims:

Aim 1. Assess detection of COVID-19 antibodies in subjects before discharge from HFHS who tested positive with RT-PCR for SARS-CoV-2 using fully automated immunoassays.

Aim 2. Evaluate emergence of immunity over a one-year period in subjects who tested positive with RT-PCR for SARS-CoV-2 using a fully-automated immunoassays.

Aim 3. Monitor renal function and kidney health at 6 and 12- months post diagnosis with COVID-19.

Aim 4. Determine if SAR-COV-2 can be detected in the saliva of patients over a one year period after a positive PCR test.

Enrollment: 829 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients ≥18 years of age
• Positive COVID-19 by RT-PCR SARS-CoV-2 assay
• Patients must have a serum sample stored by pathology or within the TCRC biorepository around the date of their COVID-19 RT-PCR positive test

Exclusion criteria

• < 18 years of age
• negative for RT-PCR
• no serum sample