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OpenTrials
Completed

NCT Number: NCT04495907

COVID-19 Progression in End-Stage Kidney Disease

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

DCR Victorville, Victorville, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. SARS-CoV-2 IgG

    Time frame: An average of 6 months

  2. Anti-SARS-CoV-2 IgG

    Time frame: An average of 6 months

Sponsors and collaborators

Lead sponsor

Davita Clinical Research

Industry

Registry information

Acronym: COPE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 3, 2020
Registry last updated
Mar 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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