Sustained Immunity to COVID-19 as Measured by SARS-CoV-2 Serology Assays
Purpose
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.
Condition
- Covid19
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible 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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Recruiting Locations
More Details
- NCT ID
- NCT04562285
- Status
- Completed
- Sponsor
- Henry Ford Health System
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. 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.