Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04495907 |
| Other study ID # |
20-M-0047-00 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 6, 2020 |
| Est. completion date |
August 31, 2021 |
Study information
| Verified date |
March 2022 |
| Source |
Davita Clinical Research |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this study is to collect genomic and clinical data among a cohort of
hemodialysis patients and analyze the association between genetic markers and the development
and severity of illness in response to SARS-CoV-2.
Description:
COVID-19 is a novel illness caused by the SARS-CoV-2 virus. It was declared as a global
pandemic on March 11, 2020 and since that time there have been outbreaks on every continent
except for Antarctica. Preliminary understanding of the virus suggests that some fraction of
the population does not manifest clinical disease in response to infection, others manifest a
relatively benign course of illness, and still others develop a fulminant course that
eventuates in the need for intensive care, mechanical ventilation, or even death. The genetic
and epigenetic basis for differential susceptibility remains unknown.
Patients receiving hemodialysis provide a good opportunity to understand genetic and
epigenetic susceptibility to SARS-CoV-2. By virtue of their ongoing requirements for care,
such patients cannot shelter at home or maintain social distancing, but must instead report
to a clinical care setting on a thrice weekly basis. Moreover, such patients often travel to
and from dialysis using shared ride services, which furthers opportunity for exposure.
Preliminary estimates suggest that rates of SARS-CoV-2 positivity are 2 to 5-fold higher
among hemodialysis patients than in the general public. Furthermore, frequent contact with
the health care system among dialysis patients makes tracking clinical course comparatively
easy.
The purpose of this study is to collect genomic and clinical data among a cohort of
hemodialysis patients and analyze the association between genetic markers and the development
and severity of illness in response to SARS-CoV-2.
