Clincosm LogoSign in Get a demo

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

Sponsor
Henry Ford Health System (Other)
Overall Status
Recruiting
CT.gov ID
NCT04562285
Collaborator
(none)
500
Enrollment
1
Location
23.3
Anticipated Duration (Months)
21.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Serologic immunoassays to SARS-CoV-2 antibodies

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 Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Initial and Sustained Immunity to SARS-CoV-2 Measured by Serologic Assays on an Automated Immunoassay System
Actual Study Start Date :
Jun 23, 2020
Actual Primary Completion Date :
May 28, 2021
Anticipated Study Completion Date :
Jun 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Detection of antibodies to SARS-CoV-2 in human serum and plasma [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Henry Ford Health System Detroit Michigan United States 48202

Sponsors and Collaborators

  • Henry Ford Health System

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bernard Cook, Division Head, Chemistry-Pathology, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT04562285
Other Study ID Numbers:
  • 13978
First Posted:
Sep 24, 2020
Last Update Posted:
Feb 10, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Bernard Cook, Division Head, Chemistry-Pathology, Henry Ford Health System
SARS-CoV-2
Antibodies
Seroprevalence
Additional relevant MeSH terms:
COVID-19
Antibodies

Study Results

No Results Posted as of Feb 10, 2022