xml: <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/NCT05965843</url>
    </required_header>
    <id_info>
      <org_study_id>2023IITXG01</org_study_id>
      <nct_id>NCT05965843</nct_id>
    </id_info>
    <brief_title>Intervention, Prognosis and Mechanism of Covid-19 Infection in Patients With Underlying Diseases</brief_title>
    <official_title>Research on the Intervention, Prognosis and Mechanism of Novel Coronavirus Infection in Patients With Underlying Diseases</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Second Affiliated Hospital of Chongqing Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The Second Affiliated Hospital of Chongqing Medical 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>
        The goal of this observational study is to explore the influence of Covid-19 infection and&#xD;
        risk factors of severe outcomes in vulnerable population including patients with chronic&#xD;
        liver disease, malignant tumor, autoimmune disease, medical staff.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          1. The clinical characteristics of vulnerable population after Covid-19 infection.&#xD;
  &#xD;
          2. Risk factors for severe illness in vulnerable groups after infection with the Covid-19.&#xD;
  &#xD;
          3. The impact of Covid-19 infection on the progression of underlying diseases.&#xD;
  &#xD;
        Information of participants will be collected such as gender, age, underlying diseases,&#xD;
        medication status, vaccination status, clinical and biochemical indicators.&#xD;
  &#xD;
        Researchers will compare the mild and severe outcomes after Covid-19 infection to identify&#xD;
        the &quot;truly vulnerable&quot; population and explore the potential mechanism and intervention for&#xD;
        these population.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2023</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>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>All-cause mortality in patients with underline disease after Covid-19 infection.</measure>
      <time_frame>30 days</time_frame>
      <description>All-cause mortality is a measure of the total number of deaths from any cause.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Severe disease in patients with underline disease after Covid-19 infection.</measure>
      <time_frame>48weeks</time_frame>
      <description>Severe disease include severe Covid-19 and/or progression of underlying disease.</description>
    </secondary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Anticipated">480</enrollment>
    <condition>Chronic Liver Disease</condition>
    <condition>Malignant Tumor</condition>
    <condition>Autoimmune Diseases</condition>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>chronic liver disease</arm_group_label>
      <description>No additional interventions for this group.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>malignant tumor</arm_group_label>
      <description>No additional interventions for this group.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>autoimmune disease</arm_group_label>
      <description>No additional interventions for this group.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>medical staff</arm_group_label>
      <description>No additional interventions for this group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>underling disease</intervention_name>
      <description>Nowadays Covid-19 virus has become milder than before however severe outcomes still happen in people with underlying diseases after infection.&#xD;
  For example, previous research indicated cirrhosis was an independent predictor for COVID-19 mortality.&#xD;
  More efforts shoud be make to explore the association between underlying diseases and severe COVID-19.</description>
      <arm_group_label>autoimmune disease</arm_group_label>
      <arm_group_label>chronic liver disease</arm_group_label>
      <arm_group_label>malignant tumor</arm_group_label>
      <arm_group_label>medical staff</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The target population was population with underling disease from single-centre and medical&#xD;
          staff from multiple centers in Chongqing.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Sign the informed consent form before enrollment, and be able to complete the research&#xD;
               according to the requirements of the research protocol.&#xD;
  &#xD;
            2. Enrolled patients need to have basic diseases, including chronic liver disease,&#xD;
               chronic kidney disease, chronic lung disease, solid tumors, AIDS, rheumatic immune&#xD;
               diseases, diabetes, etc.&#xD;
  &#xD;
            3. When entering the group, patients with new crowns need to be confirmed by evidence of&#xD;
               a positive test for new coronavirus nucleic acid (CT value &lt;35) or a positive test for&#xD;
               new coronavirus antigen.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Participate in clinical trials of other investigational drugs or medical devices&#xD;
               within 3 months before screening, and take experimental drugs or use medical devices.&#xD;
  &#xD;
            2. Positive pregnancy test during lactation or screening period.&#xD;
  &#xD;
            3. Subjects who, in the investigator's opinion, have other factors that are not suitable&#xD;
               for participating in this study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Peng Hu, PhD.</last_name>
      <role>Study Director</role>
      <affiliation>The Second Affiliated Hospital of Chongqing Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ke Qiu, MD.</last_name>
      <phone>+86 18523571923</phone>
      <email>535424396@qq.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Peng Hu, PhD.</last_name>
      <phone>+86 13608338064</phone>
      <email>hp_cq@163.com</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 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>Liver Diseases</mesh_term>
      <mesh_term>Autoimmune 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>
  
  
text: 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/NCT05965843
  org study id: 2023IITXG01
  nct id: NCT05965843
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to explore the influence of Covid-19 infection and
        risk factors of severe outcomes in vulnerable population including patients with chronic
        liver disease, malignant tumor, autoimmune disease, medical staff.
  
        The main questions it aims to answer are:
  
          1. The clinical characteristics of vulnerable population after Covid-19 infection.
  
          2. Risk factors for severe illness in vulnerable groups after infection with the Covid-19.
  
          3. The impact of Covid-19 infection on the progression of underlying diseases.
  
        Information of participants will be collected such as gender, age, underlying diseases,
        medication status, vaccination status, clinical and biochemical indicators.
  
        Researchers will compare the mild and severe outcomes after Covid-19 infection to identify
        the "truly vulnerable" population and explore the potential mechanism and intervention for
        these population.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: All-cause mortality in patients with underline disease after Covid-19 infection.
  time frame: 30 days
  description: All-cause mortality is a measure of the total number of deaths from any cause.
  measure: Severe disease in patients with underline disease after Covid-19 infection.
  time frame: 48weeks
  description: Severe disease include severe Covid-19 and/or progression of underlying disease.
  arm group label: chronic liver disease
  description: No additional interventions for this group.
  arm group label: malignant tumor
  description: No additional interventions for this group.
  arm group label: autoimmune disease
  description: No additional interventions for this group.
  arm group label: medical staff
  description: No additional interventions for this group.
  intervention type: Other
  intervention name: underling disease
  description: Nowadays Covid-19 virus has become milder than before however severe outcomes still happen in people with underlying diseases after infection.
  For example, previous research indicated cirrhosis was an independent predictor for COVID-19 mortality.
  More efforts shoud be make to explore the association between underlying diseases and severe COVID-19.
  arm group label: autoimmune disease
  arm group label: chronic liver disease
  arm group label: malignant tumor
  arm group label: medical staff
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Peng Hu, PhD.
  role: Study Director
  affiliation: The Second Affiliated Hospital of Chongqing Medical University
  last name: Ke Qiu, MD.
  phone: +86 18523571923
  email: 535424396@qq.com
  last name: Peng Hu, PhD.
  phone: +86 13608338064
  email: hp_cq@163.com
  responsible party type: Sponsor
  mesh term: Liver Diseases
  mesh term: Autoimmune Diseases
  sharing ipd: Undecided