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COVID-19 Progression in End-Stage Kidney Disease (COPE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04495907
Recruitment Status : Recruiting
First Posted : August 3, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
SARS-CoV-2 Infection (Asymptomatic) SARS-CoV-2 Infection (Symptomatic)

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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: COVID-19 Progression in End-Stage Kidney Disease
Actual Study Start Date : August 6, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Group/Cohort
Group I
Group I- Asymptomatic patients with SARS-CoV-2 Infection
Group II
Group II-Symptomatic patients with SARS-CoV-2 Infection



Primary Outcome Measures :
  1. SARS-CoV-2 IgG [ Time Frame: An average of 6 months ]
  2. Anti-SARS-CoV-2 IgG [ Time Frame: An average of 6 months ]

Biospecimen Retention:   Samples With DNA
  • 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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04495907


Contacts
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Contact: Aleah Freeman 888-345-2567 dcrpatientrecruitment@davita.com
Contact: Jeffrey Connaire 888-345-2567 dcrpatientrecruitment@davita.com

Locations
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United States, California
DCR Victorville Recruiting
Victorville, California, United States, 92394
Contact: Marisol Ortega         
United States, Connecticut
DCR Connecticut Recruiting
Bridgeport, Connecticut, United States, 06606
Contact: Helen Brickel, RN         
United States, Minnesota
DCR Twin Cities Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Ali Stockness         
United States, Nevada
DCR Las Vegas Recruiting
Las Vegas, Nevada, United States, 89128
Contact: Nicole Holquin         
United States, New York
DCR Bronx Recruiting
Bronx, New York, United States, 10461
Contact: Hoda Bashir         
United States, Ohio
DCR Canton Recruiting
Canton, Ohio, United States, 44718
Contact: Helen Brickel         
United States, Texas
DCR El Paso Recruiting
El Paso, Texas, United States, 79925
Contact: Christina Fernandez         
DCR Lewisville Recruiting
Lewisville, Texas, United States, 75057
Contact: David Ellis         
DCR San Antonio Recruiting
San Antonio, Texas, United States, 78230
Contact: Dylan Marias         
United States, Virginia
DCR Norfolk Recruiting
Norfolk, Virginia, United States, 23502
Contact: Jason Harvey         
United States, Wisconsin
DCR Milwaukee Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Tracy Mente         
Sponsors and Collaborators
Davita Clinical Research
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Responsible Party: Davita Clinical Research
ClinicalTrials.gov Identifier: NCT04495907    
Other Study ID Numbers: 20-M-0047-00
First Posted: August 3, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency