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

Recruiting

• Conditions: Covid19

• Registration Number: NCT04562285
• Lead Sponsor: Henry Ford Health System

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.

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 Timeline

• Study Start: 2020-06-23
• Study First Submitted: 2020-09-22
• Study First Submitted QC: 2020-09-22
• Study First Posted: 2020-09-24
• Primary Completion: 2021-05-28
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-19
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States