Initial and Sustained Immunity to SARS-CoV-2 Measured by Serologic Assays on an Automated Immunoassay System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Henry Ford Health System
- Enrollment
- 829
- Locations
- 1
- Primary Endpoint
- Detection of antibodies to SARS-CoV-2 in human serum and plasma
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Detection of antibodies to SARS-CoV-2 in human serum and plasma
Time Frame: 12 months
The study will 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. The study will use Beckman Coulter anti-Spike IgG assay and Roche anti-Nucleocapsid assay.
Secondary Outcomes
No secondary outcomes reported
Investigators
Bernard Cook
Division Head, Chemistry-Pathology
Henry Ford Health System