COVID-19 Progression in End-Stage Kidney Disease (COPE)

DaVita

Status: Completed

Conditions: SARS-CoV-2 Infection (Asymptomatic); SARS-CoV-2 Infection (Symptomatic)

Study type: Observational

Funder types: Industry

Identifiers

NCT04495907

20-M-0047-00

Details and patient eligibility

About

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.

Full 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.

Enrollment: 412 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Is 18 years or older at the time of consent
• Ability to provide informed consent.
• Is currently receiving hemodialysis treatment for end-stage kidney disease at a DaVita dialysis center.
• Enrollment in prior genomics study (Additional criteria for type B only)

Trial design

412 participants in 2 patient groups

Group I

Description:

Group I- Asymptomatic patients with SARS-CoV-2 Infection

Group II

Description:

Group II-Symptomatic patients with SARS-CoV-2 Infection