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

March 21, 2022 updated by: Davita Clinical Research
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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

412

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Victorville, California, United States, 92394
        • DCR Victorville
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • DCR Connecticut
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • DCR Twin Cities
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • DCR Las Vegas
    • New York
      • Bronx, New York, United States, 10461
        • DCR Bronx
    • Ohio
      • Canton, Ohio, United States, 44718
        • DCR Canton
    • Texas
      • El Paso, Texas, United States, 79925
        • DCR El Paso
      • Lewisville, Texas, United States, 75057
        • DCR Lewisville
      • San Antonio, Texas, United States, 78230
        • DCR San Antonio
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • DCR Norfolk
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • DCR Milwaukee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Type A & B participants must meet all of the following criteria:

  1. Is between 18 and 80 years of age, inclusive.
  2. Ability to provide informed consent.
  3. Is currently receiving hemodialysis treatment for end-stage kidney disease at a DaVita dialysis center.

3.2 Additional Inclusion Criteria: Type B (prior participant in genomics study)

Type B participants must meet all of the above criteria and the following criteria:

1. Enrollment in prior genomics study.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Group I
Group I- Asymptomatic patients with SARS-CoV-2 Infection
Group II
Group II-Symptomatic patients with SARS-CoV-2 Infection

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jeffrey Connaire, MD, Davita Clinical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2020

Primary Completion (Actual)

April 9, 2021

Study Completion (Actual)

August 31, 2021

Study Registration Dates

First Submitted

July 30, 2020

First Submitted That Met QC Criteria

July 30, 2020

First Posted (Actual)

August 3, 2020

Study Record Updates

Last Update Posted (Actual)

March 22, 2022

Last Update Submitted That Met QC Criteria

March 21, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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