<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/NCT04422379</url>
  </required_header>
  <id_info>
    <org_study_id>COVID 19/LI/2020</org_study_id>
    <nct_id>NCT04422379</nct_id>
  </id_info>
  <brief_title>COVID-19 and Liver Injury in Patients With or Without Underlying Liver Disease: A Multi-centre Retrospective-prospective Observational Study</brief_title>
  <official_title>COVID-19 and Liver Injury in Patients With or Without Underlying Liver Disease: A Multi-centre Retrospective-prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Max Healthcare Insititute Limited</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Max Healthcare Insititute Limited</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 and liver injury in patients with or without underlying liver disease: A&#xD;
      multi-centre retrospective-prospective observational study.&#xD;
&#xD;
      All patients infected with SARS-CoV-2 and admitted to the COVID-19 ward/ICU of Max Hospital&#xD;
      Saket (either in East Wing , Max Super Specialty Hospital, Saket or MAX Smart Super Specialty&#xD;
      Hospital, Saket) between 1/4/2020 to 30/6/2020 (retrospective data between 1/4/2020-&#xD;
      30/5/2020 &amp; prospective data from approval till 30/6/2020), will be included&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      COVID-19 and liver injury in patients with or without underlying liver disease: A&#xD;
      multi-centre retrospective-prospective observational study.&#xD;
&#xD;
      All patients infected with SARS-CoV-2 and admitted to the COVID-19 ward/ICU of Max Hospital&#xD;
      Saket (either in East Wing , Max Super Specialty Hospital, Saket or MAX Smart Super Specialty&#xD;
      Hospital, Saket) between 1/4/2020 to 30/6/2020 (retrospective data between 1/4/2020-&#xD;
      30/5/2020 &amp; prospective data from approval till 30/6/2020), will be included Primary&#xD;
      objectives&#xD;
&#xD;
        1. To study the prevalence of liver live injury &amp; factors associated with among patients&#xD;
           in-fected with SARS-CoV-2.&#xD;
&#xD;
        2. To study the prevalence of new liver injury and factors associated with it, among&#xD;
           patient with underlying liver disease who develops COVD-19.&#xD;
&#xD;
      Secondary objectives&#xD;
&#xD;
        1. To correlate the presence and degree of liver dysfunction with the clinical outcomes in&#xD;
           these patients.&#xD;
&#xD;
        2. To define the incidence of development of acute liver failure among these patients&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 7, 2020</start_date>
  <completion_date type="Anticipated">August 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 30, 2020</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>COVID-19 Positive Case</measure>
    <time_frame>4-8 weeks</time_frame>
    <description>To study the prevalence of liver live injury &amp; factors associated with among patients in-fected with SARS-CoV-2.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>COVID-19 Positive Case</measure>
    <time_frame>4-8 weeks</time_frame>
    <description>To study the prevalence of new liver injury and factors associated with it, among patient with underlying liver disease who develops COVID-19.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>COVID-19 Positive Case</measure>
    <time_frame>4-8 weeks</time_frame>
    <description>To correlate the presence and degree of liver dysfunction with the clinical outcomes in these patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>COVID-19 Positive Case</measure>
    <time_frame>4-8 weeks</time_frame>
    <description>To define the incidence of development of acute liver failure among these patients</description>
  </secondary_outcome>
  <enrollment type="Anticipated">314</enrollment>
  <condition>COVID-19</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will include all the COVID 19 patients (male &amp; female) with minimum&#xD;
        age 18 years old. And take 60% patient in Retrospective arm and 40% patient in prospective&#xD;
        arm.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:All patients infected with SARS-CoV-2 and admitted to the COVID-19&#xD;
        ward/ICU of Max Hospital Saket (either in East Wing , Max Super Specialty Hospital, Saket&#xD;
        or MAX Smart Super Specialty Hospital, Saket) between 1/4/2020 to 30/6/2020 (retrospective&#xD;
        data between 1/4/2020- 30/5/2020 &amp; prospective data from approval till 30/6/2020), will be&#xD;
        included.&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients less that 18 years old with COVID-19&#xD;
&#xD;
          2. Pregnant ladies with COVD-19&#xD;
&#xD;
          3. Unwilling to give consent for inclusion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kaushal Madan, DM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Max healthcare</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kaushal Madan, DM</last_name>
    <phone>9958787720</phone>
    <email>K_madan_2000@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Vivek Raj, DM</last_name>
    <phone>9818921051</phone>
    <email>Vivek.Raj@maxhealthcare.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Max Super Speciality Hospital, Saket (A Unit Of Devki Devi Foundation)</name>
      <address>
        <city>New Delhi</city>
        <state>Dlelhi</state>
        <zip>110017</zip>
        <country>India</country>
      </address>
    </facility>
    <contact>
      <last_name>Rajesh Saxena</last_name>
      <phone>9818474003</phone>
      <email>Rajesh.saxena@maxhealthcare.com</email>
    </contact>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 7, 2020</last_update_submitted>
  <last_update_submitted_qc>June 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</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>
    <ipd_description>IPD sharing protocol is undecided at this stage. We may, however, provide the data if requested.</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/NCT04422379
org study id: COVID 19/LI/2020
nct id: NCT04422379
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
COVID-19 and liver injury in patients with or without underlying liver disease: A
      multi-centre retrospective-prospective observational study.

      All patients infected with SARS-CoV-2 and admitted to the COVID-19 ward/ICU of Max Hospital
      Saket (either in East Wing , Max Super Specialty Hospital, Saket or MAX Smart Super Specialty
      Hospital, Saket) between 1/4/2020 to 30/6/2020 (retrospective data between 1/4/2020-
      30/5/2020 & prospective data from approval till 30/6/2020), will be included
COVID-19 and liver injury in patients with or without underlying liver disease: A
      multi-centre retrospective-prospective observational study.

      All patients infected with SARS-CoV-2 and admitted to the COVID-19 ward/ICU of Max Hospital
      Saket (either in East Wing , Max Super Specialty Hospital, Saket or MAX Smart Super Specialty
      Hospital, Saket) between 1/4/2020 to 30/6/2020 (retrospective data between 1/4/2020-
      30/5/2020 & prospective data from approval till 30/6/2020), will be included Primary
      objectives

        1. To study the prevalence of liver live injury & factors associated with among patients
           in-fected with SARS-CoV-2.

        2. To study the prevalence of new liver injury and factors associated with it, among
           patient with underlying liver disease who develops COVD-19.

      Secondary objectives

        1. To correlate the presence and degree of liver dysfunction with the clinical outcomes in
           these patients.

        2. To define the incidence of development of acute liver failure among these patients
observational model: Cohort
time perspective: Other
measure: COVID-19 Positive Case
time frame: 4-8 weeks
description: To study the prevalence of liver live injury & factors associated with among patients in-fected with SARS-CoV-2.
measure: COVID-19 Positive Case
time frame: 4-8 weeks
description: To study the prevalence of new liver injury and factors associated with it, among patient with underlying liver disease who develops COVID-19.
measure: COVID-19 Positive Case
time frame: 4-8 weeks
description: To correlate the presence and degree of liver dysfunction with the clinical outcomes in these patients.
measure: COVID-19 Positive Case
time frame: 4-8 weeks
description: To define the incidence of development of acute liver failure among these patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Kaushal Madan, DM
role: Principal Investigator
affiliation: Max healthcare
last name: Kaushal Madan, DM
phone: 9958787720
email: K_madan_2000@yahoo.com
last name: Vivek Raj, DM
phone: 9818921051
email: Vivek.Raj@maxhealthcare.com
facility: 
contact: 
country: India
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Liver Diseases
sharing ipd: Undecided
ipd description: IPD sharing protocol is undecided at this stage. We may, however, provide the data if requested.