Viewing Study NCT04495907



Ignite Creation Date: 2024-05-06 @ 3:01 PM
Last Modification Date: 2024-10-26 @ 1:41 PM
Study NCT ID: NCT04495907
Status: COMPLETED
Last Update Posted: 2022-03-22
First Post: 2020-07-30

Brief Title: COVID-19 Progression in End-Stage Kidney Disease
Sponsor: Davita Clinical Research
Organization: Davita Clinical Research

Study Overview

Official Title: COVID-19 Progression in End-Stage Kidney Disease
Status: COMPLETED
Status Verified Date: 2022-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: COPE
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None