Clinical trial NCT04495907: COVID-19 Progression in End-Stage Kidney Disease
Official title: COVID-19 Progression in End-Stage Kidney Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2 Infection (Asymptomatic)
SARS-CoV-2 Infection (Symptomatic)
Lead sponsor: Davita Clinical Research
Sponsor class: INDUSTRY
First posted: 2020-08-03
Enrollment: 412
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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)

Primary outcomes:
measure: SARS-CoV-2 IgG
timeFrame: An average of 6 months
measure: Anti-SARS-CoV-2 IgG
timeFrame: An average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Victorville
country: United States
facility: DCR Victorville
state: California
city: Bridgeport
country: United States
facility: DCR Connecticut
state: Connecticut
city: Minneapolis
country: United States
facility: DCR Twin Cities
state: Minnesota
city: Las Vegas
country: United States
facility: DCR Las Vegas
state: Nevada
city: Bronx
country: United States
facility: DCR Bronx
state: New York
city: Canton
country: United States
facility: DCR Canton
state: Ohio
city: El Paso
country: United States
facility: DCR El Paso
state: Texas
city: Lewisville
country: United States
facility: DCR Lewisville
state: Texas
city: San Antonio
country: United States
facility: DCR San Antonio
state: Texas
city: Norfolk
country: United States
facility: DCR Norfolk
state: Virginia
city: Milwaukee
country: United States
facility: DCR Milwaukee
state: Wisconsin
Study officials:
affiliation: Davita Clinical Research
name: Jeffrey Connaire, MD
role: PRINCIPAL_INVESTIGATOR
References: