COVID-19 Progression in End-Stage Kidney Disease

Completed

• Conditions: SARS-CoV-2 Infection (Asymptomatic); SARS-CoV-2 Infection (Symptomatic)

• Registration Number: NCT04495907
• Lead Sponsor: Davita Clinical Research

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.

Study Timeline

• Study First Submitted: 2020-07-30
• Study First Submitted QC: 2020-07-30
• Study First Posted: 2020-08-03
• Study Start: 2020-08-06
• Primary Completion: 2021-04-09
• Study Completion: 2021-08-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-21
• Last Update Posted: 2022-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 412

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SARS-CoV-2 IgG	An average of 6 months
Anti-SARS-CoV-2 IgG	An average of 6 months

Trial Locations

Locations (11)

DCR Canton; 🇺🇸 Canton, Ohio, United States

DCR Connecticut; 🇺🇸 Bridgeport, Connecticut, United States

DCR Victorville; 🇺🇸 Victorville, California, United States

DCR Bronx; 🇺🇸 Bronx, New York, United States

DCR San Antonio; 🇺🇸 San Antonio, Texas, United States

DCR Norfolk; 🇺🇸 Norfolk, Virginia, United States

DCR Twin Cities; 🇺🇸 Minneapolis, Minnesota, United States

DCR El Paso; 🇺🇸 El Paso, Texas, United States

DCR Lewisville; 🇺🇸 Lewisville, Texas, United States

DCR Las Vegas; 🇺🇸 Las Vegas, Nevada, United States

DCR Milwaukee; 🇺🇸 Milwaukee, Wisconsin, United States