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CompletedNCT04495907COPEUpdated Mar 22, 2022

COVID-19 Progression in End-Stage Kidney Disease

An observational study in SARS-CoV-2 Infection (Asymptomatic) and SARS-CoV-2 Infection (Symptomatic), sponsored by Davita Clinical Research. Completed at 11 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-03-22.

Sponsored by Davita Clinical Research · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
412
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • SARS-CoV-2 Infection (Asymptomatic)
  • SARS-CoV-2 Infection (Symptomatic)
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 412 is above the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Davita Clinical Research is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Eligibility 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)
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
412 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Group I

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

  • Group II

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

06

What researchers measure

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

07

Study locations

11 sites
  • DCR Victorville
    Victorville, California 92394, United States
  • DCR Connecticut
    Bridgeport, Connecticut 06606, United States
  • DCR Twin Cities
    Minneapolis, Minnesota 55404, United States
  • DCR Las Vegas
    Las Vegas, Nevada 89128, United States
  • DCR Bronx
    Bronx, New York 10461, United States
  • DCR Canton
    Canton, Ohio 44718, United States
  • DCR El Paso
    El Paso, Texas 79925, United States
  • DCR Lewisville
    Lewisville, Texas 75057, United States
  • DCR San Antonio
    San Antonio, Texas 78230, United States
  • DCR Norfolk
    Norfolk, Virginia 23502, United States
  • DCR Milwaukee
    Milwaukee, Wisconsin 53226, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04495907
Lead sponsor
Davita Clinical Research
Responsible party
Sponsor
First posted
Aug 3, 2020
Start date
Aug 6, 2020
Primary completion
Apr 9, 2021
Completion
Aug 31, 2021
Last update
Mar 22, 2022

Study contacts

Jeffrey Connaire, MD
principal investigator · Davita Clinical Research

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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