COVID-19 Progression in End-Stage Kidney Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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COVID-19 Progression in End-Stage Kidney Disease

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

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group I<br>Group I- Asymptomatic patients with SARS-CoV-2 Infection | |
| Group II<br>Group II-Symptomatic patients with SARS-CoV-2 Infection | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARS-CoV-2 IgG |  | An average of 6 months | 
| Anti-SARS-CoV-2 IgG |  | An average of 6 months |