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

November 25, 2025 updated by: Bernard Cook, Henry Ford Health System

Initial and Sustained Immunity to SARS-CoV-2 Measured by Serologic Assays on an Automated Immunoassay System

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

829

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2020

Primary Completion (Actual)

May 28, 2021

Study Completion (Actual)

June 7, 2024

Study Registration Dates

First Submitted

September 22, 2020

First Submitted That Met QC Criteria

September 22, 2020

First Posted (Actual)

September 24, 2020

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13978

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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