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COVID-19 Progression in End-Stage Kidney Disease

COVID-19 Progression in End-Stage Kidney Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04495907
Acronym
COPE
Enrollment
412
Registered
2020-08-03
Start date
2020-08-06
Completion date
2021-08-31
Last updated
2022-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-CoV-2 Infection (Asymptomatic), SARS-CoV-2 Infection (Symptomatic)

Brief 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.

Detailed 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.

Interventions

None listed

Sponsors

Davita Clinical Research
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
SARS-CoV-2 IgGAn average of 6 months
Anti-SARS-CoV-2 IgGAn average of 6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026