<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/NCT04439084</url>
  </required_header>
  <id_info>
    <org_study_id>55819</org_study_id>
    <nct_id>NCT04439084</nct_id>
  </id_info>
  <brief_title>COVID-19 in Patients With Chronic Liver Diseases</brief_title>
  <acronym>COLD</acronym>
  <official_title>COVID-19 in Patients With Chronic Liver Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</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>
      This study seeks to determine how COVID-19 affects the clinical outcome of patients with&#xD;
      chronic liver disease, and whether the clinical course of COVID-19 is influenced by&#xD;
      underlying chronic liver disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 6, 2020</start_date>
  <completion_date type="Actual">July 31, 2021</completion_date>
  <primary_completion_date type="Actual">July 31, 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>All-cause mortality</measure>
    <time_frame>30 days</time_frame>
    <description>Death due to any cause</description>
  </primary_outcome>
  <primary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>1 year</time_frame>
    <description>Death due to any cause</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Liver-related mortality</measure>
    <time_frame>28 days</time_frame>
    <description>Death due to liver-related cause</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Liver-related mortality</measure>
    <time_frame>1 year</time_frame>
    <description>Death due to liver-related cause</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Patients will be assessed for this outcome for up to 1 year</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with hepatic decompensation</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Onset of hepatic decompensation due to COVID-19 disease; patients will be assessed for this outcome for up to 1 year</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients requiring hospitalization</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Patients will be assessed for this outcome for up to 1 year.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of hospitalization</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Patients will be assessed for this outcome for up to 1 year.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of intensive care unit (ICU) stay</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Patients will be assessed for this outcome for up to 1 year.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants requiring mechanical ventilation</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Patients will be assessed for this outcome for up to 1 year.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1025</enrollment>
  <condition>COVID-19</condition>
  <condition>Chronic Liver Disease</condition>
  <arm_group>
    <arm_group_label>Chronic Liver Disease Group</arm_group_label>
    <description>COVID-19 patients with Chronic Liver Disease.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <description>COVID-19 patients without Chronic Liver Disease.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Prospective Chart Review</intervention_name>
    <description>Collected data will include demographic features, clinical characteristics, clinical outcome, medication use, COVID-19-related complications in patients with chronic liver disease.</description>
    <arm_group_label>Chronic Liver Disease Group</arm_group_label>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with chronic liver disease with a confirmed diagnosis of COVID-19&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed diagnosis of COVID-19&#xD;
&#xD;
          -  Personal history of either&#xD;
&#xD;
               -  Chronic hepatitis C&#xD;
&#xD;
               -  Chronic hepatitis B&#xD;
&#xD;
               -  Alcoholic liver disease&#xD;
&#xD;
               -  Non alcoholic liver disease&#xD;
&#xD;
               -  Autoimmune hepatitis, Primary biliary cholangitis, Primary sclerosing cholangitis&#xD;
&#xD;
               -  Cryptogenic cirrhosis&#xD;
&#xD;
               -  Hepatocellular carcinoma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-COVID-19 patient&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Renumathy Dhanasekaran, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Arizona,</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCSF Fresno</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgetown University</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Medical Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20422</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oschner Medical Center</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70816</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hennepin County Medical Center (HCMC)</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55415</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Cleveland Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Kim D, Adeniji N, Latt N, Kumar S, Bloom PP, Aby ES, Perumalswami P, Roytman M, Li M, Vogel AS, Catana AM, Wegermann K, Carr RM, Aloman C, Chen VL, Rabiee A, Sadowski B, Nguyen V, Dunn W, Chavin KD, Zhou K, Lizaola-Mayo B, Moghe A, Debes J, Lee TH, Branch AD, Viveiros K, Chan W, Chascsa DM, Kwo P, Dhanasekaran R. Predictors of Outcomes of COVID-19 in Patients With Chronic Liver Disease: US Multi-center Study. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1469-1479.e19. doi: 10.1016/j.cgh.2020.09.027. Epub 2020 Sep 17.</citation>
    <PMID>32950749</PMID>
  </results_reference>
  <results_reference>
    <citation>Rabiee A, Sadowski B, Adeniji N, Perumalswami PV, Nguyen V, Moghe A, Latt NL, Kumar S, Aloman C, Catana AM, Bloom PP, Chavin KD, Carr RM, Dunn W, Chen VL, Aby ES, Debes JD, Dhanasekaran R; COLD Consortium. Liver Injury in Liver Transplant Recipients With Coronavirus Disease 2019 (COVID-19): U.S. Multicenter Experience. Hepatology. 2020 Dec;72(6):1900-1911. doi: 10.1002/hep.31574. Epub 2020 Dec 9.</citation>
    <PMID>32964510</PMID>
  </results_reference>
  <results_reference>
    <citation>Adeniji N, Carr RM, Aby ES, Catana AM, Wegermann K, Dhanasekaran R. Socioeconomic Factors Contribute to the Higher Risk of COVID-19 in Racial and Ethnic Minorities With Chronic Liver Diseases. Gastroenterology. 2021 Mar;160(4):1406-1409.e3. doi: 10.1053/j.gastro.2020.11.035. Epub 2020 Nov 20. No abstract available.</citation>
    <PMID>33227281</PMID>
  </results_reference>
  <results_reference>
    <citation>Efe C, Dhanasekaran R, Lammert C, Ebik B, Higuera-de la Tijera F, Aloman C, Riza Caliskan A, Peralta M, Gerussi A, Massoumi H, Catana AM, Torgutalp M, Purnak T, Rigamonti C, Gomez Aldana AJ, Khakoo N, Kacmaz H, Nazal L, Frager S, Demir N, Irak K, Ellik ZM, Balaban Y, Atay K, Eren F, Cristoferi L, Batibay E, Urzua A, Snijders R, Kiyici M, Akyildiz M, Ekin N, Carr RM, Harputluoglu M, Hatemi I, Mendizabal M, Silva M, Idilman R, Silveira M, Drenth JPH, Assis DN, Bjornsson E, Boyer JL, Invernizzi P, Levy C, Schiano TD, Ridruejo E, Wahlin S. Outcome of COVID-19 in Patients With Autoimmune Hepatitis: An International Multicenter Study. Hepatology. 2021 Jun;73(6):2099-2109. doi: 10.1002/hep.31797. Erratum In: Hepatology. 2022 Mar;75(3):774.</citation>
    <PMID>33713486</PMID>
  </results_reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>August 5, 2021</last_update_submitted>
  <last_update_submitted_qc>August 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2021</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>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/NCT04439084
org study id: 55819
nct id: NCT04439084
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study seeks to determine how COVID-19 affects the clinical outcome of patients with
      chronic liver disease, and whether the clinical course of COVID-19 is influenced by
      underlying chronic liver disease.
observational model: Cohort
time perspective: Prospective
measure: All-cause mortality
time frame: 30 days
description: Death due to any cause
measure: All-cause mortality
time frame: 1 year
description: Death due to any cause
measure: Liver-related mortality
time frame: 28 days
description: Death due to liver-related cause
measure: Liver-related mortality
time frame: 1 year
description: Death due to liver-related cause
measure: Overall survival
time frame: Up to 1 year
description: Patients will be assessed for this outcome for up to 1 year
measure: Number of patients with hepatic decompensation
time frame: Up to 1 year
description: Onset of hepatic decompensation due to COVID-19 disease; patients will be assessed for this outcome for up to 1 year
measure: Number of patients requiring hospitalization
time frame: Up to 1 year
description: Patients will be assessed for this outcome for up to 1 year.
measure: Duration of hospitalization
time frame: Up to 1 year
description: Patients will be assessed for this outcome for up to 1 year.
measure: Length of intensive care unit (ICU) stay
time frame: Up to 1 year
description: Patients will be assessed for this outcome for up to 1 year.
measure: Number of participants requiring mechanical ventilation
time frame: Up to 1 year
description: Patients will be assessed for this outcome for up to 1 year.
arm group label: Chronic Liver Disease Group
description: COVID-19 patients with Chronic Liver Disease.
arm group label: Control Group
description: COVID-19 patients without Chronic Liver Disease.
intervention type: Other
intervention name: Prospective Chart Review
description: Collected data will include demographic features, clinical characteristics, clinical outcome, medication use, COVID-19-related complications in patients with chronic liver disease.
arm group label: Chronic Liver Disease Group
arm group label: Control Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Renumathy Dhanasekaran, MD
role: Principal Investigator
affiliation: Stanford University
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Kim D, Adeniji N, Latt N, Kumar S, Bloom PP, Aby ES, Perumalswami P, Roytman M, Li M, Vogel AS, Catana AM, Wegermann K, Carr RM, Aloman C, Chen VL, Rabiee A, Sadowski B, Nguyen V, Dunn W, Chavin KD, Zhou K, Lizaola-Mayo B, Moghe A, Debes J, Lee TH, Branch AD, Viveiros K, Chan W, Chascsa DM, Kwo P, Dhanasekaran R. Predictors of Outcomes of COVID-19 in Patients With Chronic Liver Disease: US Multi-center Study. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1469-1479.e19. doi: 10.1016/j.cgh.2020.09.027. Epub 2020 Sep 17.
PMID: 32950749
citation: Rabiee A, Sadowski B, Adeniji N, Perumalswami PV, Nguyen V, Moghe A, Latt NL, Kumar S, Aloman C, Catana AM, Bloom PP, Chavin KD, Carr RM, Dunn W, Chen VL, Aby ES, Debes JD, Dhanasekaran R; COLD Consortium. Liver Injury in Liver Transplant Recipients With Coronavirus Disease 2019 (COVID-19): U.S. Multicenter Experience. Hepatology. 2020 Dec;72(6):1900-1911. doi: 10.1002/hep.31574. Epub 2020 Dec 9.
PMID: 32964510
citation: Adeniji N, Carr RM, Aby ES, Catana AM, Wegermann K, Dhanasekaran R. Socioeconomic Factors Contribute to the Higher Risk of COVID-19 in Racial and Ethnic Minorities With Chronic Liver Diseases. Gastroenterology. 2021 Mar;160(4):1406-1409.e3. doi: 10.1053/j.gastro.2020.11.035. Epub 2020 Nov 20. No abstract available.
PMID: 33227281
citation: Efe C, Dhanasekaran R, Lammert C, Ebik B, Higuera-de la Tijera F, Aloman C, Riza Caliskan A, Peralta M, Gerussi A, Massoumi H, Catana AM, Torgutalp M, Purnak T, Rigamonti C, Gomez Aldana AJ, Khakoo N, Kacmaz H, Nazal L, Frager S, Demir N, Irak K, Ellik ZM, Balaban Y, Atay K, Eren F, Cristoferi L, Batibay E, Urzua A, Snijders R, Kiyici M, Akyildiz M, Ekin N, Carr RM, Harputluoglu M, Hatemi I, Mendizabal M, Silva M, Idilman R, Silveira M, Drenth JPH, Assis DN, Bjornsson E, Boyer JL, Invernizzi P, Levy C, Schiano TD, Ridruejo E, Wahlin S. Outcome of COVID-19 in Patients With Autoimmune Hepatitis: An International Multicenter Study. Hepatology. 2021 Jun;73(6):2099-2109. doi: 10.1002/hep.31797. Erratum In: Hepatology. 2022 Mar;75(3):774.
PMID: 33713486
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Liver Diseases
sharing ipd: No