- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04495907
COVID-19 Progression in End-Stage Kidney Disease (COPE)
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Victorville, California, United States, 92394
- DCR Victorville
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Connecticut
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Bridgeport, Connecticut, United States, 06606
- DCR Connecticut
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Minnesota
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Minneapolis, Minnesota, United States, 55404
- DCR Twin Cities
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Nevada
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Las Vegas, Nevada, United States, 89128
- DCR Las Vegas
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New York
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Bronx, New York, United States, 10461
- DCR Bronx
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Ohio
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Canton, Ohio, United States, 44718
- DCR Canton
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Texas
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El Paso, Texas, United States, 79925
- DCR El Paso
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Lewisville, Texas, United States, 75057
- DCR Lewisville
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San Antonio, Texas, United States, 78230
- DCR San Antonio
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Virginia
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Norfolk, Virginia, United States, 23502
- DCR Norfolk
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- DCR Milwaukee
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Type A & B participants must meet all of the following criteria:
- Is between 18 and 80 years of age, inclusive.
- Ability to provide informed consent.
- 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.
Description
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)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
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Group I
Group I- Asymptomatic patients with SARS-CoV-2 Infection
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Group II
Group II-Symptomatic patients with SARS-CoV-2 Infection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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SARS-CoV-2 IgG
Time Frame: An average of 6 months
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An average of 6 months
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Anti-SARS-CoV-2 IgG
Time Frame: An average of 6 months
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An average of 6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jeffrey Connaire, MD, Davita Clinical Research
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Urologic Diseases
- Disease Attributes
- Renal Insufficiency
- Renal Insufficiency, Chronic
- COVID-19
- Kidney Diseases
- Infections
- Communicable Diseases
- Kidney Failure, Chronic
Other Study ID Numbers
- 20-M-0047-00
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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