<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/NCT04407221</url>
  </required_header>
  <id_info>
    <org_study_id>COV-19-SU-TX</org_study_id>
    <nct_id>NCT04407221</nct_id>
  </id_info>
  <brief_title>COVID-19 Research in Organ Transplant Recipients</brief_title>
  <acronym>CORONA</acronym>
  <official_title>COVID-19 Research in Organ Transplant Recipients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vastra Gotaland Region</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vastra Gotaland Region</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>
      COVID-19 is a global major public health emergency that disproportionately affects patients&#xD;
      with risk factors such as advanced age, heart and lung disease, diabetes, hypertension, as&#xD;
      well as compromised immunity. Despite the recent worldwide emergence of this disease and its&#xD;
      rapid progression to a pandemic, very little is known about the risks facing solid organ&#xD;
      recipients. The study aims to elucidate the prevalence of symptomatic, subclinical, and&#xD;
      asymptomatic infection in the transplanted population by assessing their immunological&#xD;
      response to SARS-CoV-2 infection. This will be studied seroepidemiologically in the whole&#xD;
      cohort and retrospectively in transplanted patients admitted to hospital for COVID-19.&#xD;
&#xD;
      Primary objective: to elucidate the cumulative prevalence of SARS-CoV-2 infection in the&#xD;
      transplanted population related to symptoms and hospitalizations; to assess the magnitude of&#xD;
      immunological response and seroconversion kinetics for COVID-19. Secondary objectives: To&#xD;
      examine the influence of medical parameters on COVID-19 infection and immune response such&#xD;
      as: age, comorbidities current and recent pharmacological treatment, organ transplanted, and&#xD;
      blood type, HLA genotype.&#xD;
&#xD;
      Study design:&#xD;
&#xD;
      Part 1: Longitudinal cohort study for seroepidemiology and disease burden. Part 2:&#xD;
      Retrospective case-series for seroconversion kinetics and clinical course assessment.&#xD;
&#xD;
      Study population:&#xD;
&#xD;
      All solid organ transplanted patients in Sweden&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will assess the clinical course, the outcome, and the immunologic response of organ&#xD;
      transplant patients who have had COVID-19 (participants); The investigators aim to study the&#xD;
      development of the immune response to COVID-19 infection to see if participants on&#xD;
      immunosuppressive treatment, will establish sufficient immunity to protect against&#xD;
      reinfection. The findings among participants will be compared to a suitable control&#xD;
      population. In addition, the investigators will identify patients in our cohort who are&#xD;
      undergoing clinically apparent infections and study their clinical course and antibody&#xD;
      response profile in the acute phase (seroconversion).&#xD;
&#xD;
      Control groups: Other current studies with matched protocols and WHO pooled data.&#xD;
&#xD;
      Overall study design Part 1: Potential participants are all patients who have undergone solid&#xD;
      organ transplantation (SOT) in Sweden will be invited to participate in the longitudinal&#xD;
      cohort seroprevalence part of the study (approximately 1000 patients will be included). This&#xD;
      part of the study is a single-center longitudinal cohort study that will evaluate the&#xD;
      development of antibodies against SARS-CoV-2 in solid organ recipients at all stages after&#xD;
      transplantation and study their disease course, complications, and death rate.&#xD;
&#xD;
      The study has been designed to follow the best practices outlined by the WHO in their recent&#xD;
      guidelines entitled &quot;Population-based age-stratified seroepidemiological investigation&#xD;
      protocol for COVID-19 virus infection COVID-19 v1.1&quot;. This will allow a comparison of&#xD;
      symptoms, outcomes, case fatality rate, as well as antibody titers and prevalence, with other&#xD;
      relevant control groups. Participant enrollment will be allowed for a maximum of 2 years. The&#xD;
      duration of the study will be two years from enrollment. The last participant will thus&#xD;
      complete follow-up a maximum of 4 years after the commencement of the study Part 2: The&#xD;
      investigators will also do a retrospective assessment of transplanted patients in Sweden with&#xD;
      PCR confirmed COVID-19.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">June 16, 2020</start_date>
  <completion_date type="Anticipated">May 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2024</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>Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)</measure>
    <time_frame>0 months</time_frame>
    <description>Cumulative presence of SARS-CoV-2 antibodies in plasma.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)</measure>
    <time_frame>3 months</time_frame>
    <description>Cumulative presence of SARS-CoV-2 antibodies in plasma.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)</measure>
    <time_frame>6 months</time_frame>
    <description>Cumulative presence of SARS-CoV-2 antibodies in plasma.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)</measure>
    <time_frame>9 months</time_frame>
    <description>Cumulative presence of SARS-CoV-2 antibodies in plasma.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)</measure>
    <time_frame>12 months</time_frame>
    <description>Cumulative presence of SARS-CoV-2 antibodies in plasma.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)</measure>
    <time_frame>15 months</time_frame>
    <description>Cumulative presence of SARS-CoV-2 antibodies in plasma.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)</measure>
    <time_frame>18 months</time_frame>
    <description>Cumulative presence of SARS-CoV-2 antibodies in plasma.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)</measure>
    <time_frame>21 months</time_frame>
    <description>Cumulative presence of SARS-CoV-2 antibodies in plasma.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)</measure>
    <time_frame>24 months</time_frame>
    <description>Cumulative presence of SARS-CoV-2 antibodies in plasma.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in levels of SARS-Cov-2 antibodies (antibody titers)</measure>
    <time_frame>0-24 months</time_frame>
    <description>Change in titers of SARS-CoV-2 antibodies in plasma over time.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cellular response to SARS-Cov-2 (Th4 and Th8 levels)</measure>
    <time_frame>3 months</time_frame>
    <description>PBMC specific responses, measured in PCR/serology positive patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cellular response to SARS-Cov-2 (Th4 and Th8 levels)</measure>
    <time_frame>12 months</time_frame>
    <description>PBMC specific responses, measured in PCR/serology positive patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cellular response to SARS-Cov-2 (Th4 and Th8 levels)</measure>
    <time_frame>24 months</time_frame>
    <description>PBMC specific responses, measured in PCR/serology positive patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cellular response to SARS-Cov-2 (Th4 and Th8 levels)</measure>
    <time_frame>0-24 months</time_frame>
    <description>Change in PBMC specific responses over time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms and hospitalisations (electronic questionnaire)</measure>
    <time_frame>0 months</time_frame>
    <description>Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms and hospitalisations (electronic questionnaire)</measure>
    <time_frame>3 months</time_frame>
    <description>Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms and hospitalisations (electronic questionnaire)</measure>
    <time_frame>6 months</time_frame>
    <description>Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms and hospitalisations (electronic questionnaire)</measure>
    <time_frame>9 months</time_frame>
    <description>Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms and hospitalisations (electronic questionnaire)</measure>
    <time_frame>12 months</time_frame>
    <description>Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms and hospitalisations (electronic questionnaire)</measure>
    <time_frame>15 months</time_frame>
    <description>Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms and hospitalisations (electronic questionnaire)</measure>
    <time_frame>18 months</time_frame>
    <description>Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms and hospitalisations (electronic questionnaire)</measure>
    <time_frame>21 months</time_frame>
    <description>Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms and hospitalisations (electronic questionnaire)</measure>
    <time_frame>24 months</time_frame>
    <description>Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">1100</enrollment>
  <condition>Transplant Recipients</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Part 1:&#xD;
&#xD;
      Plasma for serology PBMC&#xD;
&#xD;
      Part 2:&#xD;
&#xD;
      Plasma for serology PBMC Urine Stool NP or sputum swab&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All patients who have received a solid organ transplant can be offered to take part in the&#xD;
        study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A patient who has undergone solid organ transplantation in Sweden&#xD;
&#xD;
          -  Must be able to take part in data reporting activities, sign the consent form, and&#xD;
             submit blood samples at predefined intervals.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -Patients under 18 years of age.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mihai Oltean, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Transplant Institute, Sahlgrenska University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>John M Søfteland, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Transplant Institute, Sahlgrenska University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Vanda Friman, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Department of Infectious diseases, Gothenburg University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Transplant Institute</name>
      <address>
        <city>Gothenburg</city>
        <state>Vastra Gotaland</state>
        <zip>41345</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>May 3, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>January 3, 2021</last_update_submitted>
  <last_update_submitted_qc>January 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vastra Gotaland Region</investigator_affiliation>
    <investigator_full_name>John Søfteland</investigator_full_name>
    <investigator_title>Consultant transplant surgeon</investigator_title>
  </responsible_party>
  <keyword>Transplant Recipients</keyword>
  <keyword>COVID-19 pandemic</keyword>
  <keyword>COVID-19 virus</keyword>
  <keyword>COVID-19 diagnostic testing</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>No</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/NCT04407221
org study id: COV-19-SU-TX
nct id: NCT04407221
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
COVID-19 is a global major public health emergency that disproportionately affects patients
      with risk factors such as advanced age, heart and lung disease, diabetes, hypertension, as
      well as compromised immunity. Despite the recent worldwide emergence of this disease and its
      rapid progression to a pandemic, very little is known about the risks facing solid organ
      recipients. The study aims to elucidate the prevalence of symptomatic, subclinical, and
      asymptomatic infection in the transplanted population by assessing their immunological
      response to SARS-CoV-2 infection. This will be studied seroepidemiologically in the whole
      cohort and retrospectively in transplanted patients admitted to hospital for COVID-19.

      Primary objective: to elucidate the cumulative prevalence of SARS-CoV-2 infection in the
      transplanted population related to symptoms and hospitalizations; to assess the magnitude of
      immunological response and seroconversion kinetics for COVID-19. Secondary objectives: To
      examine the influence of medical parameters on COVID-19 infection and immune response such
      as: age, comorbidities current and recent pharmacological treatment, organ transplanted, and
      blood type, HLA genotype.

      Study design:

      Part 1: Longitudinal cohort study for seroepidemiology and disease burden. Part 2:
      Retrospective case-series for seroconversion kinetics and clinical course assessment.

      Study population:

      All solid organ transplanted patients in Sweden
The study will assess the clinical course, the outcome, and the immunologic response of organ
      transplant patients who have had COVID-19 (participants); The investigators aim to study the
      development of the immune response to COVID-19 infection to see if participants on
      immunosuppressive treatment, will establish sufficient immunity to protect against
      reinfection. The findings among participants will be compared to a suitable control
      population. In addition, the investigators will identify patients in our cohort who are
      undergoing clinically apparent infections and study their clinical course and antibody
      response profile in the acute phase (seroconversion).

      Control groups: Other current studies with matched protocols and WHO pooled data.

      Overall study design Part 1: Potential participants are all patients who have undergone solid
      organ transplantation (SOT) in Sweden will be invited to participate in the longitudinal
      cohort seroprevalence part of the study (approximately 1000 patients will be included). This
      part of the study is a single-center longitudinal cohort study that will evaluate the
      development of antibodies against SARS-CoV-2 in solid organ recipients at all stages after
      transplantation and study their disease course, complications, and death rate.

      The study has been designed to follow the best practices outlined by the WHO in their recent
      guidelines entitled "Population-based age-stratified seroepidemiological investigation
      protocol for COVID-19 virus infection COVID-19 v1.1". This will allow a comparison of
      symptoms, outcomes, case fatality rate, as well as antibody titers and prevalence, with other
      relevant control groups. Participant enrollment will be allowed for a maximum of 2 years. The
      duration of the study will be two years from enrollment. The last participant will thus
      complete follow-up a maximum of 4 years after the commencement of the study Part 2: The
      investigators will also do a retrospective assessment of transplanted patients in Sweden with
      PCR confirmed COVID-19.
observational model: Cohort
time perspective: Prospective
measure: Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
time frame: 0 months
description: Cumulative presence of SARS-CoV-2 antibodies in plasma.
measure: Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
time frame: 3 months
description: Cumulative presence of SARS-CoV-2 antibodies in plasma.
measure: Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
time frame: 6 months
description: Cumulative presence of SARS-CoV-2 antibodies in plasma.
measure: Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
time frame: 9 months
description: Cumulative presence of SARS-CoV-2 antibodies in plasma.
measure: Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
time frame: 12 months
description: Cumulative presence of SARS-CoV-2 antibodies in plasma.
measure: Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
time frame: 15 months
description: Cumulative presence of SARS-CoV-2 antibodies in plasma.
measure: Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
time frame: 18 months
description: Cumulative presence of SARS-CoV-2 antibodies in plasma.
measure: Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
time frame: 21 months
description: Cumulative presence of SARS-CoV-2 antibodies in plasma.
measure: Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
time frame: 24 months
description: Cumulative presence of SARS-CoV-2 antibodies in plasma.
measure: Change in levels of SARS-Cov-2 antibodies (antibody titers)
time frame: 0-24 months
description: Change in titers of SARS-CoV-2 antibodies in plasma over time.
measure: Cellular response to SARS-Cov-2 (Th4 and Th8 levels)
time frame: 3 months
description: PBMC specific responses, measured in PCR/serology positive patients.
measure: Cellular response to SARS-Cov-2 (Th4 and Th8 levels)
time frame: 12 months
description: PBMC specific responses, measured in PCR/serology positive patients.
measure: Cellular response to SARS-Cov-2 (Th4 and Th8 levels)
time frame: 24 months
description: PBMC specific responses, measured in PCR/serology positive patients.
measure: Change in cellular response to SARS-Cov-2 (Th4 and Th8 levels)
time frame: 0-24 months
description: Change in PBMC specific responses over time
measure: Symptoms and hospitalisations (electronic questionnaire)
time frame: 0 months
description: Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
measure: Symptoms and hospitalisations (electronic questionnaire)
time frame: 3 months
description: Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
measure: Symptoms and hospitalisations (electronic questionnaire)
time frame: 6 months
description: Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
measure: Symptoms and hospitalisations (electronic questionnaire)
time frame: 9 months
description: Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
measure: Symptoms and hospitalisations (electronic questionnaire)
time frame: 12 months
description: Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
measure: Symptoms and hospitalisations (electronic questionnaire)
time frame: 15 months
description: Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
measure: Symptoms and hospitalisations (electronic questionnaire)
time frame: 18 months
description: Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
measure: Symptoms and hospitalisations (electronic questionnaire)
time frame: 21 months
description: Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
measure: Symptoms and hospitalisations (electronic questionnaire)
time frame: 24 months
description: Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
Part 1:

      Plasma for serology PBMC

      Part 2:

      Plasma for serology PBMC Urine Stool NP or sputum swab
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mihai Oltean, MD, PhD
role: Study Chair
affiliation: Transplant Institute, Sahlgrenska University
last name: John M Søfteland, MD, PhD
role: Principal Investigator
affiliation: Transplant Institute, Sahlgrenska University
last name: Vanda Friman, MD, PhD
role: Study Director
affiliation: Department of Infectious diseases, Gothenburg University
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Vastra Gotaland Region
investigator full name: John Søfteland
investigator title: Consultant transplant surgeon
mesh term: COVID-19
sharing ipd: No