<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04495907</url>
  </required_header>
  <id_info>
    <org_study_id>20-M-0047-00</org_study_id>
    <nct_id>NCT04495907</nct_id>
  </id_info>
  <brief_title>COVID-19 Progression in End-Stage Kidney Disease</brief_title>
  <acronym>COPE</acronym>
  <official_title>COVID-19 Progression in End-Stage Kidney Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Davita Clinical Research</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Davita Clinical Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to collect genomic and clinical data among a cohort of&#xD;
      hemodialysis patients and analyze the association between genetic markers and the development&#xD;
      and severity of illness in response to SARS-CoV-2.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      COVID-19 is a novel illness caused by the SARS-CoV-2 virus. It was declared as a global&#xD;
      pandemic on March 11, 2020 and since that time there have been outbreaks on every continent&#xD;
      except for Antarctica. Preliminary understanding of the virus suggests that some fraction of&#xD;
      the population does not manifest clinical disease in response to infection, others manifest a&#xD;
      relatively benign course of illness, and still others develop a fulminant course that&#xD;
      eventuates in the need for intensive care, mechanical ventilation, or even death. The genetic&#xD;
      and epigenetic basis for differential susceptibility remains unknown.&#xD;
&#xD;
      Patients receiving hemodialysis provide a good opportunity to understand genetic and&#xD;
      epigenetic susceptibility to SARS-CoV-2. By virtue of their ongoing requirements for care,&#xD;
      such patients cannot shelter at home or maintain social distancing, but must instead report&#xD;
      to a clinical care setting on a thrice weekly basis. Moreover, such patients often travel to&#xD;
      and from dialysis using shared ride services, which furthers opportunity for exposure.&#xD;
      Preliminary estimates suggest that rates of SARS-CoV-2 positivity are 2 to 5-fold higher&#xD;
      among hemodialysis patients than in the general public. Furthermore, frequent contact with&#xD;
      the health care system among dialysis patients makes tracking clinical course comparatively&#xD;
      easy.&#xD;
&#xD;
      The purpose of this study is to collect genomic and clinical data among a cohort of&#xD;
      hemodialysis patients and analyze the association between genetic markers and the development&#xD;
      and severity of illness in response to SARS-CoV-2.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 6, 2020</start_date>
  <completion_date type="Actual">August 31, 2021</completion_date>
  <primary_completion_date type="Actual">April 9, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>SARS-CoV-2 IgG</measure>
    <time_frame>An average of 6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti-SARS-CoV-2 IgG</measure>
    <time_frame>An average of 6 months</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">412</enrollment>
  <condition>SARS-CoV-2 Infection (Asymptomatic)</condition>
  <condition>SARS-CoV-2 Infection (Symptomatic)</condition>
  <arm_group>
    <arm_group_label>Group I</arm_group_label>
    <description>Group I- Asymptomatic patients with SARS-CoV-2 Infection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II</arm_group_label>
    <description>Group II-Symptomatic patients with SARS-CoV-2 Infection</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      -  SARS-CoV-2 IgG&#xD;
&#xD;
        -  Genomic testing will be performed on participants with positive anti-SARS-CoV-2 IgG&#xD;
           and/or with history of positive SARS-CoV-2 PCR results.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Type A &amp; B participants must meet all of the following criteria:&#xD;
&#xD;
          1. Is between 18 and 80 years of age, inclusive.&#xD;
&#xD;
          2. Ability to provide informed consent.&#xD;
&#xD;
          3. Is currently receiving hemodialysis treatment for end-stage kidney disease at a DaVita&#xD;
             dialysis center.&#xD;
&#xD;
        3.2 Additional Inclusion Criteria: Type B (prior participant in genomics study)&#xD;
&#xD;
        Type B participants must meet all of the above criteria and the following criteria:&#xD;
&#xD;
        1. Enrollment in prior genomics study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Is 18 years or older at the time of consent&#xD;
&#xD;
          -  Ability to provide informed consent.&#xD;
&#xD;
          -  Is currently receiving hemodialysis treatment for end-stage kidney disease at a DaVita&#xD;
             dialysis center.&#xD;
&#xD;
          -  Enrollment in prior genomics study (Additional criteria for type B only)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey Connaire, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Davita Clinical Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>DCR Victorville</name>
      <address>
        <city>Victorville</city>
        <state>California</state>
        <zip>92394</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DCR Connecticut</name>
      <address>
        <city>Bridgeport</city>
        <state>Connecticut</state>
        <zip>06606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DCR Twin Cities</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DCR Las Vegas</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DCR Bronx</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DCR Canton</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <zip>44718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DCR El Paso</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79925</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DCR Lewisville</name>
      <address>
        <city>Lewisville</city>
        <state>Texas</state>
        <zip>75057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DCR San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DCR Norfolk</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DCR Milwaukee</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>March 21, 2022</last_update_submitted>
  <last_update_submitted_qc>March 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04495907
org study id: 20-M-0047-00
nct id: NCT04495907
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Other
measure: SARS-CoV-2 IgG
time frame: An average of 6 months
measure: Anti-SARS-CoV-2 IgG
time frame: An average of 6 months
arm group label: Group I
description: Group I- Asymptomatic patients with SARS-CoV-2 Infection
arm group label: Group II
description: Group II-Symptomatic patients with SARS-CoV-2 Infection
-  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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jeffrey Connaire, MD
role: Principal Investigator
affiliation: Davita Clinical Research
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: COVID-19
mesh term: Kidney Diseases
mesh term: Kidney Failure, Chronic