Assessing COVID-19 antibody responses and kidney health over one year
Initial and Sustained Immunity to SARS-CoV-2 Measured by Serologic Assays on an Automated Immunoassay System
This study looks at how COVID-19 affects antibody levels and kidney health in people who tested positive for the virus over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Henry Ford Health System Academic / other |
| Locations | 1 site (Detroit, Michigan) |
| Trial ID | NCT04562285 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the immune response to COVID-19 by measuring IgG and IgM antibodies in patients who tested positive for SARS-CoV-2 at Henry Ford Health System. It will track these antibody levels during hospitalization and for up to 12 months post-infection. Additionally, the study will monitor kidney health and function in these patients over the same period. The research utilizes fully automated immunoassays to ensure accurate detection of antibodies and will also investigate the presence of the virus in saliva over time.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have tested positive for COVID-19 via RT-PCR and have a stored serum sample.
Not a fit: Patients under 18 years of age or those who tested negative for COVID-19 will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into long-term immunity and kidney health in COVID-19 survivors.
How similar studies have performed: Other studies have shown success in assessing immune responses to COVID-19, making this approach both relevant and valuable.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Detroit, Michigan
- Henry Ford Health System — Detroit, Michigan, United States (Recruiting)
Study contacts
- Study coordinator: Bernard C Cook, PhD
- Email: bcook10@hfhs.org
- Phone: 3139160134
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.