<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/NCT04420637</url>
  </required_header>
  <id_info>
    <org_study_id>RetroCov</org_study_id>
    <nct_id>NCT04420637</nct_id>
  </id_info>
  <brief_title>Impact of the Covid-19 Pandemic on Gastrointestinal and Liver Diseases</brief_title>
  <acronym>RetroCov</acronym>
  <official_title>Impact of the Covid-19 Pandemic on Gastrointestinal and Liver Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Graz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Graz</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 study aims primarily&#xD;
&#xD;
        1. to assess the frequency, nature and outcome of liver disease caused or associated with&#xD;
           COVD-19 Furthermore, the study also aims&#xD;
&#xD;
        2. to assess the impact of COVID-19 on patients with chronic liver disease or after liver&#xD;
           transplantation (frequency of infections, course of disease, outcome)&#xD;
&#xD;
        3. to assess, whether quarantine measures impact on the rate of decompensation of liver&#xD;
           cirrhosis&#xD;
&#xD;
        4. to assess whether the intake of antiviral drugs protects against SARS-CoV-2 infection or&#xD;
           COVID disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The outbreak of the novel coronavirus (SARS-CoV-2)-infected disease (COVID-19) began in&#xD;
      Wuhan, Hubei province in December 2019, spread throughout China in early 2020 and developed&#xD;
      as a pandemic thereafter. Although the virus mainly causes respiratory symptoms, GI&#xD;
      presentations have been reported in and outside of China. Patients may present with anorexia,&#xD;
      nausea, vomiting and abdominal discomfort. Also, faecal-oral transmission of the virus is&#xD;
      currently discussed. Preliminary, unpublished data from China suggest that patients with GI&#xD;
      symptoms may suffer more frequently from severe courses of the disease. Furthermore, liver&#xD;
      injury has been observed during COVID-19 disease.&#xD;
&#xD;
      It is currently unclear, whether patients with chronic liver diseases are at a higher risk to&#xD;
      contract COVID-19, to develop a more severe disease course or exhibit higher mortality.&#xD;
      Preliminary unpublished communications report conflicting data on COVID-19 in patients with&#xD;
      chronic liver diseases. According to those reports, it seems that immunosuppressed&#xD;
      individuals (e.g. stable patients after liver transplantation or patients with autoimmune&#xD;
      liver disease) do not suffer from more severe pulmonary disease when infected with SARS-CoV-2&#xD;
      compared to non-immunosuppressed individuals. To understand the impact of Covid-19 disease on&#xD;
      patients with liver diseases, two registries have been launched to collect anonymous data&#xD;
      (SECURE-cirrhosis and COVID-Hep.net). As by 1st of April 24 cases with 4 fatalities have been&#xD;
      reported, however, this system does not provide enough information to understand the risk of&#xD;
      patients in more detail, since it is unknown if all patients are reported and how many&#xD;
      patients were at risk. Furthermore, the available data are very superficial.&#xD;
&#xD;
      Besides the direct effects of COVID-19, patients with chronic liver diseases might also be&#xD;
      vulnerable to the indirect effects of the pandemic. Quarantine measures may have considerable&#xD;
      psychological impact and may cause post-traumatic stress symptoms, confusion, and anger.&#xD;
      There is no available data on the impact of quarantine on risk behaviour, such as alcohol&#xD;
      consumption or the use of other liver toxic substances. Such behaviour - although destructive&#xD;
      for everyone - can increase the risk of decompensation in patients with liver cirrhosis and&#xD;
      cause potentially lethal complications which might require intensive care. Furthermore, the&#xD;
      difficulty of access to care for patients with chronic diseases may impact negatively on the&#xD;
      course of chronic diseases. To date, it is unclear whether the restricted social life and the&#xD;
      restrictions in access to care during the pandemic impacts on liver-related morbidity and&#xD;
      mortality.&#xD;
&#xD;
      Another possibility of how studying patients with liver diseases can benefit the general&#xD;
      population, is to analyse their medications. Patients with chronic liver disease receive a&#xD;
      specialised set of drugs, some of which might be effective against SARS-CoV-2. Unfortunately,&#xD;
      the first emergency trial using ritonavir/Lopinavir - antiviral substances that are used to&#xD;
      treat HIV and HIV/Hepatitis B or C coinfections - showed disappointing results against&#xD;
      SARS-CoV-2. However, other antiviral drugs, for example against hepatitis C, could&#xD;
      theoretically also be beneficial. It is currently unknown if patients who take drugs against&#xD;
      viral hepatitis may be protected against COVID-19 and a retrospective risk assessment might&#xD;
      contribute to more informed studies and a more rational distribution of resources.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Actual">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">December 31, 2022</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>liver disease</measure>
    <time_frame>through study completion, on average 30 days</time_frame>
    <description>elevated transaminases</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>COVID infection in patients with chronic liver disease</measure>
    <time_frame>during the pandemic, at longest until 31.12.2022</time_frame>
    <description>frequency of COVID infection in patients with known chronic liver disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>decompensation of cirrhosis</measure>
    <time_frame>during the pandemic, at longest until 31.12.2022</time_frame>
    <description>episodes of decompensation of cirrhosis in relation to quarantine measures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of Antiviral drugs on Covid-19 infection</measure>
    <time_frame>during the pandemic, at longest until 31.12.2022</time_frame>
    <description>frequency of infections in people taking antiviral drugs against hepatitis B or C</description>
  </secondary_outcome>
  <enrollment type="Actual">1366</enrollment>
  <condition>COVID</condition>
  <eligibility>
    <study_pop>
      <textblock>
        all patients with Covid-19 infection treated within the hospital group&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Covid-19 infection treated within the KAGES (Steirische Krankenanstalten GesmBH = Styrian&#xD;
        public hospitals)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Internal Medicine, Medical University of Graz</name>
      <address>
        <city>Graz</city>
        <zip>8010</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>January 11, 2023</last_update_submitted>
  <last_update_submitted_qc>January 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2023</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>COVID-19</mesh_term>
    <mesh_term>Liver Diseases</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/NCT04420637
org study id: RetroCov
nct id: NCT04420637
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims primarily

        1. to assess the frequency, nature and outcome of liver disease caused or associated with
           COVD-19 Furthermore, the study also aims

        2. to assess the impact of COVID-19 on patients with chronic liver disease or after liver
           transplantation (frequency of infections, course of disease, outcome)

        3. to assess, whether quarantine measures impact on the rate of decompensation of liver
           cirrhosis

        4. to assess whether the intake of antiviral drugs protects against SARS-CoV-2 infection or
           COVID disease.
The outbreak of the novel coronavirus (SARS-CoV-2)-infected disease (COVID-19) began in
      Wuhan, Hubei province in December 2019, spread throughout China in early 2020 and developed
      as a pandemic thereafter. Although the virus mainly causes respiratory symptoms, GI
      presentations have been reported in and outside of China. Patients may present with anorexia,
      nausea, vomiting and abdominal discomfort. Also, faecal-oral transmission of the virus is
      currently discussed. Preliminary, unpublished data from China suggest that patients with GI
      symptoms may suffer more frequently from severe courses of the disease. Furthermore, liver
      injury has been observed during COVID-19 disease.

      It is currently unclear, whether patients with chronic liver diseases are at a higher risk to
      contract COVID-19, to develop a more severe disease course or exhibit higher mortality.
      Preliminary unpublished communications report conflicting data on COVID-19 in patients with
      chronic liver diseases. According to those reports, it seems that immunosuppressed
      individuals (e.g. stable patients after liver transplantation or patients with autoimmune
      liver disease) do not suffer from more severe pulmonary disease when infected with SARS-CoV-2
      compared to non-immunosuppressed individuals. To understand the impact of Covid-19 disease on
      patients with liver diseases, two registries have been launched to collect anonymous data
      (SECURE-cirrhosis and COVID-Hep.net). As by 1st of April 24 cases with 4 fatalities have been
      reported, however, this system does not provide enough information to understand the risk of
      patients in more detail, since it is unknown if all patients are reported and how many
      patients were at risk. Furthermore, the available data are very superficial.

      Besides the direct effects of COVID-19, patients with chronic liver diseases might also be
      vulnerable to the indirect effects of the pandemic. Quarantine measures may have considerable
      psychological impact and may cause post-traumatic stress symptoms, confusion, and anger.
      There is no available data on the impact of quarantine on risk behaviour, such as alcohol
      consumption or the use of other liver toxic substances. Such behaviour - although destructive
      for everyone - can increase the risk of decompensation in patients with liver cirrhosis and
      cause potentially lethal complications which might require intensive care. Furthermore, the
      difficulty of access to care for patients with chronic diseases may impact negatively on the
      course of chronic diseases. To date, it is unclear whether the restricted social life and the
      restrictions in access to care during the pandemic impacts on liver-related morbidity and
      mortality.

      Another possibility of how studying patients with liver diseases can benefit the general
      population, is to analyse their medications. Patients with chronic liver disease receive a
      specialised set of drugs, some of which might be effective against SARS-CoV-2. Unfortunately,
      the first emergency trial using ritonavir/Lopinavir - antiviral substances that are used to
      treat HIV and HIV/Hepatitis B or C coinfections - showed disappointing results against
      SARS-CoV-2. However, other antiviral drugs, for example against hepatitis C, could
      theoretically also be beneficial. It is currently unknown if patients who take drugs against
      viral hepatitis may be protected against COVID-19 and a retrospective risk assessment might
      contribute to more informed studies and a more rational distribution of resources.
observational model: Cohort
time perspective: Retrospective
measure: liver disease
time frame: through study completion, on average 30 days
description: elevated transaminases
measure: COVID infection in patients with chronic liver disease
time frame: during the pandemic, at longest until 31.12.2022
description: frequency of COVID infection in patients with known chronic liver disease
measure: decompensation of cirrhosis
time frame: during the pandemic, at longest until 31.12.2022
description: episodes of decompensation of cirrhosis in relation to quarantine measures
measure: Effect of Antiviral drugs on Covid-19 infection
time frame: during the pandemic, at longest until 31.12.2022
description: frequency of infections in people taking antiviral drugs against hepatitis B or C
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Austria
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Liver Diseases
sharing ipd: Undecided