<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/NCT04410471</url>
  </required_header>
  <id_info>
    <org_study_id>Sero-Covid19_TH</org_study_id>
    <nct_id>NCT04410471</nct_id>
  </id_info>
  <brief_title>Humoral Immunity Against SARS-CoV-2 in Liver Transplanted Patients After COVID-19 in Comparison With Immunocompetent Patients</brief_title>
  <official_title>Development and Persistence of Humoral Immunity Against SARS-CoV-2 in Liver Transplanted Patients in Comparison With Immunocompetent Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Magdalena Salcedo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital General Universitario Gregorio Marañon</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 prospective study analyzing the development of humoral immune response against&#xD;
      SARS-Cov-2 in patients with previous Covid19: the aim is to compare the incidence, titration&#xD;
      and evolution of IgG an IgM in a prospective cohort of liver transplant patients surviving to&#xD;
      the first wave of Covid19, in comparison to not inmmunossupressed patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The liver transplant (HT) recipient population is more susceptible to infections than the&#xD;
      general population. Few data are available regarding the incidence and clinical course of&#xD;
      SARS-CoV-2 infection in this population, initially considered to be &quot;high risk&quot; regarding a&#xD;
      possible higher incidence and severity of infection in these patients.&#xD;
&#xD;
      A prospective cohort of liver transplant recipient patients diagnosed with SARS-CoV-2&#xD;
      infection (Clinical Trials.gov Protocol Record HCB / 2020/0384) has been developed from SETH&#xD;
      (Spanish Society for Liver Transplantation). This study aims to analyze the incidence and&#xD;
      establish the clinical evolution of the infection in these patients. Initial data from the&#xD;
      cohort, which includes 111 incidental cases diagnosed as of April 7, show a higher&#xD;
      standardized incidence than the general population, but not higher mortality (data being&#xD;
      published).&#xD;
&#xD;
      The chronic immunosuppression in t solid organ transplant patients could play a double role&#xD;
      with respect to SARS-Cov-2 infection: on the one hand, it may condition a greater&#xD;
      susceptibility and initial aggressiveness, in relation to itself viral effect, and in the&#xD;
      other hand, it could protect by reducing the immune response that triggers the pulmonary and&#xD;
      systemic inflammatory process.&#xD;
&#xD;
      After the initial Covid-19 outbreak, both in the general population and in immunosuppressed&#xD;
      patients, the rate of specific IgM and IgG seroconversion against this coronavirus, and its&#xD;
      protective capacity against reactivations or reinfections, are unknown. Therefore, it is a&#xD;
      challenge for health organizations to identify the immune response in the population and to&#xD;
      characterize its degree of protection, to adopt early measures to lessen the consequences of&#xD;
      possible epidemic waves in the coming months.&#xD;
&#xD;
      Continuing with the prospective study of the cohort of liver transplant patients diagnosed&#xD;
      with Covid-19 (SETH-Covid-19), already defined and composed of 91 living patients, the&#xD;
      humoral immune response and its evolution in the first 12 months after initial infection. The&#xD;
      cohort will incorporate the new incidental cases; A comparative study will be carried out&#xD;
      with a contemporary cohort of non-immunosuppressed patients, controlled for age, gender and&#xD;
      severity of the initial disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 29, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">May 29, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Incidence of IgG against SARS-CoV-2</measure>
    <time_frame>one year</time_frame>
    <description>Proportion, Rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>titration and evolution of humoral response (IgG) along first 12 months after having Covid-19</measure>
    <time_frame>12 months</time_frame>
    <description>Titer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reinfection of Covid-19</measure>
    <time_frame>one year</time_frame>
    <description>Categoric Yes/Not</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Mortality</measure>
    <time_frame>12 months after Covid-19</time_frame>
    <description>Rate</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Liver Transplant Infection</condition>
  <condition>Covid19</condition>
  <condition>Mortality</condition>
  <condition>Immune Response</condition>
  <arm_group>
    <arm_group_label>Liver transplant patient after having Covid19</arm_group_label>
    <description>Adult Liver transplant patient who had survived to Covid19 in the first wave of the disease in Spain (disease until june 30th), in all the liver Transplant Units in Spain (24).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No immunosuppressed patient with previous Covid19</arm_group_label>
    <description>Not immunosuppressed patient who had survived to Covid19 in the first wave of the disease. These patient have been diagnosed and treated in the Hospital Gregorio Marañón (Madrid), before 30th June</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>CLIA of IgG and IgM against SARS-Cov-2</intervention_name>
    <description>Report of clinical data</description>
    <arm_group_label>Liver transplant patient after having Covid19</arm_group_label>
    <arm_group_label>No immunosuppressed patient with previous Covid19</arm_group_label>
    <other_name>Nasopharyngeal PCR test of SARS-Cov-2</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Liver transplant and control patients (propensity score including age, sex, and severity of&#xD;
        previous covid19 episode)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients recovered of covid 19 Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Chemotherapy on going Concomitant Autoimmune diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Magdalena Salcedo, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Liver Transplantation Unit</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Magdalena Salcedo, MD PhD</last_name>
    <phone>+34609751256</phone>
    <email>magdalena.salcedo@salud.madrid.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Maricela Valerio, MD</last_name>
    <phone>+34915866687</phone>
    <email>maricela.valerio@salud.madrid.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Victor Fernandez Alonso</name>
      <address>
        <city>Madrid</city>
        <zip>28009</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Victor Fernandez Alonso</last_name>
      <phone>+34915866687</phone>
      <email>victor.fernandez@iisgm.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Victor Fernández Alonso</name>
      <address>
        <city>Madrid</city>
        <zip>28009</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Victor Fernández, Nurse</last_name>
      <phone>+34915866687</phone>
      <email>victor.fernandez@iisgm.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>May 30, 2020</last_update_submitted>
  <last_update_submitted_qc>May 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hospital General Universitario Gregorio Marañon</investigator_affiliation>
    <investigator_full_name>Magdalena Salcedo</investigator_full_name>
    <investigator_title>Attending Physician, Hepatology</investigator_title>
  </responsible_party>
  <keyword>Humoral Immunity</keyword>
  <keyword>Reinfection</keyword>
  <keyword>IgG and IgM against SARS-CoV-2</keyword>
  <keyword>Immunosuppression</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>
    <ipd_description>Multicenter study</ipd_description>
  </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/NCT04410471
org study id: Sero-Covid19_TH
nct id: NCT04410471
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective study analyzing the development of humoral immune response against
      SARS-Cov-2 in patients with previous Covid19: the aim is to compare the incidence, titration
      and evolution of IgG an IgM in a prospective cohort of liver transplant patients surviving to
      the first wave of Covid19, in comparison to not inmmunossupressed patients.
The liver transplant (HT) recipient population is more susceptible to infections than the
      general population. Few data are available regarding the incidence and clinical course of
      SARS-CoV-2 infection in this population, initially considered to be "high risk" regarding a
      possible higher incidence and severity of infection in these patients.

      A prospective cohort of liver transplant recipient patients diagnosed with SARS-CoV-2
      infection (Clinical Trials.gov Protocol Record HCB / 2020/0384) has been developed from SETH
      (Spanish Society for Liver Transplantation). This study aims to analyze the incidence and
      establish the clinical evolution of the infection in these patients. Initial data from the
      cohort, which includes 111 incidental cases diagnosed as of April 7, show a higher
      standardized incidence than the general population, but not higher mortality (data being
      published).

      The chronic immunosuppression in t solid organ transplant patients could play a double role
      with respect to SARS-Cov-2 infection: on the one hand, it may condition a greater
      susceptibility and initial aggressiveness, in relation to itself viral effect, and in the
      other hand, it could protect by reducing the immune response that triggers the pulmonary and
      systemic inflammatory process.

      After the initial Covid-19 outbreak, both in the general population and in immunosuppressed
      patients, the rate of specific IgM and IgG seroconversion against this coronavirus, and its
      protective capacity against reactivations or reinfections, are unknown. Therefore, it is a
      challenge for health organizations to identify the immune response in the population and to
      characterize its degree of protection, to adopt early measures to lessen the consequences of
      possible epidemic waves in the coming months.

      Continuing with the prospective study of the cohort of liver transplant patients diagnosed
      with Covid-19 (SETH-Covid-19), already defined and composed of 91 living patients, the
      humoral immune response and its evolution in the first 12 months after initial infection. The
      cohort will incorporate the new incidental cases; A comparative study will be carried out
      with a contemporary cohort of non-immunosuppressed patients, controlled for age, gender and
      severity of the initial disease.
observational model: Case-Control
time perspective: Prospective
measure: Incidence of IgG against SARS-CoV-2
time frame: one year
description: Proportion, Rate
measure: titration and evolution of humoral response (IgG) along first 12 months after having Covid-19
time frame: 12 months
description: Titer
measure: Reinfection of Covid-19
time frame: one year
description: Categoric Yes/Not
measure: Mortality
time frame: 12 months after Covid-19
description: Rate
arm group label: Liver transplant patient after having Covid19
description: Adult Liver transplant patient who had survived to Covid19 in the first wave of the disease in Spain (disease until june 30th), in all the liver Transplant Units in Spain (24).
arm group label: No immunosuppressed patient with previous Covid19
description: Not immunosuppressed patient who had survived to Covid19 in the first wave of the disease. These patient have been diagnosed and treated in the Hospital Gregorio Marañón (Madrid), before 30th June
intervention type: Diagnostic Test
intervention name: CLIA of IgG and IgM against SARS-Cov-2
description: Report of clinical data
arm group label: Liver transplant patient after having Covid19
arm group label: No immunosuppressed patient with previous Covid19
other name: Nasopharyngeal PCR test of SARS-Cov-2
Serum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
last name: Magdalena Salcedo, MD PhD
role: Principal Investigator
affiliation: Liver Transplantation Unit
last name: Magdalena Salcedo, MD PhD
phone: +34609751256
email: magdalena.salcedo@salud.madrid.org
last name: Maricela Valerio, MD
phone: +34915866687
email: maricela.valerio@salud.madrid.org
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Sponsor-Investigator
investigator affiliation: Hospital General Universitario Gregorio Marañon
investigator full name: Magdalena Salcedo
investigator title: Attending Physician, Hepatology
mesh term: COVID-19
sharing ipd: Undecided
ipd description: Multicenter study