<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/NCT04495764</url>
  </required_header>
  <id_info>
    <org_study_id>20-M-0044-00</org_study_id>
    <nct_id>NCT04495764</nct_id>
  </id_info>
  <brief_title>Registry of Sustained Immunity to COVID-19 Among ESKD Patients</brief_title>
  <acronym>RePAiR</acronym>
  <official_title>Registry of Sustained Immunity to COVID-19 Among ESKD Patients</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>
      This is a multi-center, prospective registry study of subjects undergoing hemodialysis for&#xD;
      treatment of end-stage renal disease in a DaVita center.&#xD;
&#xD;
      The objective of this study is to understand whether and to what degree anti-SARS-CoV-2&#xD;
      antibodies mitigate the risk of subsequent SARS-CoV-2 infection and COVID disease within the&#xD;
      ESKD population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multi-center, prospective registry study of subjects undergoing hemodialysis for&#xD;
      treatment of end-stage renal disease in a DaVita center.&#xD;
&#xD;
      The objective of this study is to understand whether and to what degree anti-SARS-CoV-2&#xD;
      antibodies mitigate the risk of subsequent SARS-CoV-2 infection and COVID disease within the&#xD;
      ESKD population.&#xD;
&#xD;
      Following informed consent, participants will undergo baseline serologic characterization for&#xD;
      anti-SARS-CoV-2 IgM and IgG. The study is planned to align with the present wave of COVID-19.&#xD;
      Enrollment will continue until the total sample size of 2500 is reached or until the study&#xD;
      sponsor determines. Should there be a subsequent wave of COVID- 19, participants will be&#xD;
      actively surveiled for evidence of SARS-CoV-2 infection and for COVID-19 disease. The&#xD;
      relationship between baseline serologic status and subsequent infection/disease will be&#xD;
      determined.&#xD;
&#xD;
      This study will have 2 distinct phases.&#xD;
&#xD;
      Phase 1 (baseline characterization) start will be triggered by the sponsor and may start at&#xD;
      different times at the active sites. Participants will be consented and enrolled and blood&#xD;
      will be collected for anti-SARS-CoV-2 antibodies.&#xD;
&#xD;
      Phase 2: Start will be triggered by the sponsor in the fall of 2020 and each geographic study&#xD;
      location may be triggered to start at separate times. Study participants will be followed&#xD;
      prospectively for incidence and severity of COVID-19. Study visits will commence upon sponsor&#xD;
      trigger and will occur once monthly for 4 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Actual">February 12, 2021</completion_date>
  <primary_completion_date type="Actual">February 12, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Anti-SARS-CoV-2 antibodies</measure>
    <time_frame>Through study completion (5 visits), an average of 6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence and severity of COVID-19</measure>
    <time_frame>Through study completion (5 visits), an average of 6 months</time_frame>
  </primary_outcome>
  <enrollment type="Actual">2315</enrollment>
  <condition>SARS-CoV-2 Infection</condition>
  <condition>Anti-SARS-CoV-2 Infection</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Baseline serologic characterization for anti-SARS-CoV-2 IgM and IgG&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        1. Between ≥18 and 80 years of age, inclusive.&#xD;
&#xD;
          2. Ability to provide informed consent.&#xD;
&#xD;
          3. Currently receiving hemodialysis treatment for end-stage kidney disease at a DaVita&#xD;
             dialysis center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between ≥18 and 80 years of age, inclusive.&#xD;
&#xD;
          -  Ability to provide informed consent.&#xD;
&#xD;
          -  Currently receiving hemodialysis treatment for end-stage kidney disease at a DaVita&#xD;
             dialysis center.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#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>Francesca Tentori, 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>78215</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>May 2021</verification_date>
  <study_first_submitted>July 22, 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>May 26, 2021</last_update_submitted>
  <last_update_submitted_qc>May 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Immunoglobulin G</keyword>
  <keyword>Immunoglobulin M</keyword>
  <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>
  </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/NCT04495764
org study id: 20-M-0044-00
nct id: NCT04495764
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a multi-center, prospective registry study of subjects undergoing hemodialysis for
      treatment of end-stage renal disease in a DaVita center.

      The objective of this study is to understand whether and to what degree anti-SARS-CoV-2
      antibodies mitigate the risk of subsequent SARS-CoV-2 infection and COVID disease within the
      ESKD population.
This is a multi-center, prospective registry study of subjects undergoing hemodialysis for
      treatment of end-stage renal disease in a DaVita center.

      The objective of this study is to understand whether and to what degree anti-SARS-CoV-2
      antibodies mitigate the risk of subsequent SARS-CoV-2 infection and COVID disease within the
      ESKD population.

      Following informed consent, participants will undergo baseline serologic characterization for
      anti-SARS-CoV-2 IgM and IgG. The study is planned to align with the present wave of COVID-19.
      Enrollment will continue until the total sample size of 2500 is reached or until the study
      sponsor determines. Should there be a subsequent wave of COVID- 19, participants will be
      actively surveiled for evidence of SARS-CoV-2 infection and for COVID-19 disease. The
      relationship between baseline serologic status and subsequent infection/disease will be
      determined.

      This study will have 2 distinct phases.

      Phase 1 (baseline characterization) start will be triggered by the sponsor and may start at
      different times at the active sites. Participants will be consented and enrolled and blood
      will be collected for anti-SARS-CoV-2 antibodies.

      Phase 2: Start will be triggered by the sponsor in the fall of 2020 and each geographic study
      location may be triggered to start at separate times. Study participants will be followed
      prospectively for incidence and severity of COVID-19. Study visits will commence upon sponsor
      trigger and will occur once monthly for 4 months.
observational model: Cohort
time perspective: Prospective
measure: Anti-SARS-CoV-2 antibodies
time frame: Through study completion (5 visits), an average of 6 months
measure: Incidence and severity of COVID-19
time frame: Through study completion (5 visits), an average of 6 months
Baseline serologic characterization for anti-SARS-CoV-2 IgM and IgG
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Francesca Tentori, MD
role: Principal Investigator
affiliation: Davita Clinical Research
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: COVID-19