<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/NCT04487197</url>
  </required_header>
  <id_info>
    <org_study_id>COVID-SIERO TRAPIANTI</org_study_id>
    <nct_id>NCT04487197</nct_id>
  </id_info>
  <brief_title>SARS-CoV2 (COVID-19) Seroepidemiological Transplanted Subjects (Kidney, Kidney-pancreas, Pancreas, Langerhans Islets)</brief_title>
  <official_title>SARS-CoV2 (COVID-19) Seroepidemiological Investigation in Transplanted Population Subjects of Kidney, Kidney-pancreas, Isolated Pancreas, Langerhans Islets</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Antonio Secchi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS San Raffaele</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluate SARS-CoV2 infection and the degree of immunity possibly developed in transplanted&#xD;
      population using the Luciferase Immuno Precipitation System (LIPS) test.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Actual">January 15, 2021</completion_date>
  <primary_completion_date type="Actual">January 15, 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>Serum-prevalence of COVID-19 TX</measure>
    <time_frame>From 15 July 2020 to 15 January 2021</time_frame>
    <description>Evaluation of serum-prevalence data transplanted patients (symptomatic vs asymptomatic patients)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum-prevalence of COVID-19 / Age, Gender, Type of transplantation, comorbities, Italian regions-proviences transplanted patients</measure>
    <time_frame>From 15 July 2020 to 15 January 2021</time_frame>
    <description>Correlation serum-prevalence of COVID-19 / Age, Gender, Type of transplantation, comorbities, Italian regions-proviences transplanted patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Asymptomatic or subclinical infections in transplanted patients</measure>
    <time_frame>From 15 July 2020 to 15 January 2021</time_frame>
    <description>Determine % Asymptomatic or subclinical infections in transplanted patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk factors for infection COVID-19 transplanted patients</measure>
    <time_frame>From 15 July 2020 to 15 January 2021</time_frame>
    <description>Determine risk factors for infection COVID-19 (comparison symtomatic and asymtomatic transplanted patients)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization rate COVID-19 transplanted patients</measure>
    <time_frame>From 15 July 2020 to 15 January 2021</time_frame>
    <description>Evaluate hospitalization rate in transplanted patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality rate COVID-19 transplanted patients</measure>
    <time_frame>From 15 July 2020 to 15 January 2021</time_frame>
    <description>Evaluate mortality rate in transplanted patients</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">282</enrollment>
  <condition>Kidney Transplant</condition>
  <condition>Pancreatic Transplat</condition>
  <condition>Pancreatic Islets Langerhans</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <description>Adult patients (age ≥ 18 years),&#xD;
kidney or pancreas or pancreatic islets transplantation&#xD;
transplanted patients (period: 01.01.2020 to 30.06.2020)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2</arm_group_label>
    <description>Adult patients (age ≥ 18 years),&#xD;
kidney or pancreas or pancreatic islets transplantation&#xD;
Transplanted patients in follow-up since 01.01.2020 or trasplanted patients after 30.06.2020.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>blood sample for seroepidemiological investigation</intervention_name>
    <description>blood sample for seroepidemiological investigation</description>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_label>Cohort 2</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Transplanted Kidney, Pancreas or Pancreatic Islet patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria Cohort 1:&#xD;
&#xD;
          -  Adult patients (age ≥ 18 years),&#xD;
&#xD;
          -  Kidney or pancreas or pancreatic islets transplantation&#xD;
&#xD;
          -  Transplanted patients (period: 01.01.2020 to 30.06.2020)&#xD;
&#xD;
          -  Informed Consent signed&#xD;
&#xD;
        Inclusion Criteria Cohort 2:&#xD;
&#xD;
          -  Adult patients (age ≥ 18 years),&#xD;
&#xD;
          -  Kidney or pancreas or pancreatic islets transplantation&#xD;
&#xD;
          -  transplanted patients in follow-up since 01.01.2020 or trasplanted patients after&#xD;
             30.06.2020.&#xD;
&#xD;
          -  Informed Consent signed&#xD;
&#xD;
        Exclusion Criteria both Cohort (1&amp;2):&#xD;
&#xD;
        Symptomatology such as fever&gt; 37.5, and / or cough and / or respiratory distress and / or&#xD;
        diarrhea / vomiting in 14 days prior to collection of blood sample&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>IRCCS San Raffaele</name>
      <address>
        <city>Milan</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>February 9, 2021</last_update_submitted>
  <last_update_submitted_qc>February 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS San Raffaele</investigator_affiliation>
    <investigator_full_name>Antonio Secchi</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>COVID-19 infection</keyword>
  <keyword>Transplanted patients</keyword>
  <keyword>kidney transplants</keyword>
  <keyword>pancreas transplants</keyword>
  <keyword>pancreatic islet transplantation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04487197
org study id: COVID-SIERO TRAPIANTI
nct id: NCT04487197
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Evaluate SARS-CoV2 infection and the degree of immunity possibly developed in transplanted
      population using the Luciferase Immuno Precipitation System (LIPS) test.
observational model: Cohort
time perspective: Other
measure: Serum-prevalence of COVID-19 TX
time frame: From 15 July 2020 to 15 January 2021
description: Evaluation of serum-prevalence data transplanted patients (symptomatic vs asymptomatic patients)
measure: Serum-prevalence of COVID-19 / Age, Gender, Type of transplantation, comorbities, Italian regions-proviences transplanted patients
time frame: From 15 July 2020 to 15 January 2021
description: Correlation serum-prevalence of COVID-19 / Age, Gender, Type of transplantation, comorbities, Italian regions-proviences transplanted patients
measure: Asymptomatic or subclinical infections in transplanted patients
time frame: From 15 July 2020 to 15 January 2021
description: Determine % Asymptomatic or subclinical infections in transplanted patients
measure: Risk factors for infection COVID-19 transplanted patients
time frame: From 15 July 2020 to 15 January 2021
description: Determine risk factors for infection COVID-19 (comparison symtomatic and asymtomatic transplanted patients)
measure: Hospitalization rate COVID-19 transplanted patients
time frame: From 15 July 2020 to 15 January 2021
description: Evaluate hospitalization rate in transplanted patients
measure: Mortality rate COVID-19 transplanted patients
time frame: From 15 July 2020 to 15 January 2021
description: Evaluate mortality rate in transplanted patients
arm group label: Cohort 1
description: Adult patients (age ≥ 18 years),
kidney or pancreas or pancreatic islets transplantation
transplanted patients (period: 01.01.2020 to 30.06.2020)
arm group label: Cohort 2
description: Adult patients (age ≥ 18 years),
kidney or pancreas or pancreatic islets transplantation
Transplanted patients in follow-up since 01.01.2020 or trasplanted patients after 30.06.2020.
intervention type: Procedure
intervention name: blood sample for seroepidemiological investigation
description: blood sample for seroepidemiological investigation
arm group label: Cohort 1
arm group label: Cohort 2
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Italy
responsible party type: Sponsor-Investigator
investigator affiliation: IRCCS San Raffaele
investigator full name: Antonio Secchi
investigator title: MD
mesh term: COVID-19
sharing ipd: Undecided