Sustained Immunity to COVID-19 as Measured by SARS-CoV-2 Serology Assays
Initial and Sustained Immunity to SARS-CoV-2 Measured by Serologic Assays on an Automated Immunoassay System
1 other identifier
observational
829
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 23, 2020
CompletedFirst Submitted
Initial submission to the registry
September 22, 2020
CompletedFirst Posted
Study publicly available on registry
September 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2024
CompletedDecember 3, 2025
November 1, 2025
11 months
September 22, 2020
November 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Detection of antibodies to SARS-CoV-2 in human serum and plasma
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.
12 months
Interventions
Detect and characterize antibodies to SARS-CoV-2
Eligibility Criteria
subjects will be identified from a retrospective data review and a laboratory information system (LIS) SunQuest identification of COVID-19 positive (RT-PCR SARS CoV-2) samples or who are already participating in the TCRC collection protocol. This study will recruit subjects in which a baseline serum sample was already obtained either through standard of care procedures or through voluntary participation in the TCRC biorepository.
You may qualify if:
- 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
You may not qualify if:
- \< 18 years of age
- negative for RT-PCR
- no serum sample
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Henry Ford Health System
Detroit, Michigan, 48202, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Division Head, Chemistry-Pathology
Study Record Dates
First Submitted
September 22, 2020
First Posted
September 24, 2020
Study Start
June 23, 2020
Primary Completion
May 28, 2021
Study Completion
June 7, 2024
Last Updated
December 3, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share