COVID-19 Progression in End-Stage Kidney Disease
COPE
1 other identifier
observational
412
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2020
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2020
CompletedFirst Posted
Study publicly available on registry
August 3, 2020
CompletedStudy Start
First participant enrolled
August 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2021
CompletedMarch 22, 2022
March 1, 2022
8 months
July 30, 2020
March 21, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
SARS-CoV-2 IgG
An average of 6 months
Anti-SARS-CoV-2 IgG
An average of 6 months
Study Arms (2)
Group I
Group I- Asymptomatic patients with SARS-CoV-2 Infection
Group II
Group II-Symptomatic patients with SARS-CoV-2 Infection
Eligibility Criteria
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.
You may qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
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
The 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
Biospecimen
* SARS-CoV-2 IgG * Genomic testing will be performed on participants with positive anti-SARS-CoV-2 IgG and/or with history of positive SARS-CoV-2 PCR results.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey Connaire, MD
Davita Clinical Research
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2020
First Posted
August 3, 2020
Study Start
August 6, 2020
Primary Completion
April 9, 2021
Study Completion
August 31, 2021
Last Updated
March 22, 2022
Record last verified: 2022-03