NCT04562285

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 829 (actual)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Covid19

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Serologic immunoassays to SARS-CoV-2 antibodies	Detect and characterize antibodies to SARS-CoV-2

Timeline

• Start date: 2020-06-23
• Primary completion: 2021-05-28
• Completion: 2024-06-07
• First posted: 2020-09-24
• Last updated: 2025-12-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study