<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/NCT04477889</url>
  </required_header>
  <id_info>
    <org_study_id>024.CRI.2020.A</org_study_id>
    <nct_id>NCT04477889</nct_id>
  </id_info>
  <brief_title>Methodist Health System COVID-19 Patient Registry</brief_title>
  <official_title>Methodist Health System COVID-19 Patient Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Methodist Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Methodist Health System</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 cohort observational registry study that will include data on all&#xD;
      patients who are treated at MHS facilities for COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective cohort observational registry study that will include data on all&#xD;
      patients who are treated at MHS facilities for COVID-19. Data including, but not limited to&#xD;
      demographics, comorbidities, medications, treatment, and clinical outcomes will be collected&#xD;
      from February 2020 to December 2025. Subjects will undergo no additional tests or procedures&#xD;
      as part of this registry study. All patient data will be obtained from the patient's&#xD;
      electronic health records (EHR) of the hospital or clinic in a retrospective manner. The&#xD;
      process for gathering the data will not influence treatment decisions. There will be no&#xD;
      direct patient contact associated with inclusion in this registry study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 20, 2020</start_date>
  <completion_date type="Anticipated">December 2026</completion_date>
  <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Characteristics</measure>
    <time_frame>June 2020 - Dec 2025</time_frame>
    <description>Patient characteristics</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment Measures and Intervention strategies</measure>
    <time_frame>June 2020 - Dec 2025</time_frame>
    <description>Treatment measures and intervention strategies</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical and survival outcomes</measure>
    <time_frame>June 2020 - Dec 2025</time_frame>
    <description>Clinical and survival outcomes</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>COVID-19 Cohort</arm_group_label>
    <description>Patients treated at MHS facilites for COVID-19</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Synopsis for COVID Bariatric, Hepato-Biliary and Colorectal surgery study</arm_group_label>
    <description>30 Day Mortality after surgery in patients with COVID19 infection who undergo elective bariatric, hepato-biliary and colorectal surgery.&#xD;
Patients diagnosed with COVID-19 at the time of surgery up to seven days before surgery&#xD;
Patients diagnosed with COVID-19 within 30 days after surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment for COVID-19</intervention_name>
    <description>Patients treated for COVID-19</description>
    <arm_group_label>COVID-19 Cohort</arm_group_label>
    <arm_group_label>Synopsis for COVID Bariatric, Hepato-Biliary and Colorectal surgery study</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All adult patients who are treated at MHS facilities for COVID-19.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient tested positive for COVID-19 (SARS-CoV-2)&#xD;
&#xD;
          -  Patient sought care for COVID-19 at a MHS facility&#xD;
&#xD;
          -  Aged 18 years or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient that do not have COVID-19&#xD;
&#xD;
          -  Non-confirmed COVID-19 patients&#xD;
&#xD;
          -  Aged 17 years or younger&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Crystee Cooper, DHEd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Methodist Health System</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Crystee Cooper, DHEd</last_name>
    <phone>214-947-1285</phone>
    <email>clinicalresearch@mhd.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zaid Haddadin, MS</last_name>
    <phone>214-947-4604</phone>
    <email>clinicalresearch@mhd.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Clinical Research Institute Methodist Health System</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Crystee Cooper, DHEd</last_name>
      <phone>214-941-1285</phone>
      <email>CrysteeCooper@mhd.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 6, 2023</last_update_submitted>
  <last_update_submitted_qc>July 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 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>
  </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/NCT04477889
org study id: 024.CRI.2020.A
nct id: NCT04477889
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective cohort observational registry study that will include data on all
      patients who are treated at MHS facilities for COVID-19.
This is a prospective cohort observational registry study that will include data on all
      patients who are treated at MHS facilities for COVID-19. Data including, but not limited to
      demographics, comorbidities, medications, treatment, and clinical outcomes will be collected
      from February 2020 to December 2025. Subjects will undergo no additional tests or procedures
      as part of this registry study. All patient data will be obtained from the patient's
      electronic health records (EHR) of the hospital or clinic in a retrospective manner. The
      process for gathering the data will not influence treatment decisions. There will be no
      direct patient contact associated with inclusion in this registry study.
observational model: Other
time perspective: Prospective
measure: Patient Characteristics
time frame: June 2020 - Dec 2025
description: Patient characteristics
measure: Treatment Measures and Intervention strategies
time frame: June 2020 - Dec 2025
description: Treatment measures and intervention strategies
measure: Clinical and survival outcomes
time frame: June 2020 - Dec 2025
description: Clinical and survival outcomes
arm group label: COVID-19 Cohort
description: Patients treated at MHS facilites for COVID-19
arm group label: Synopsis for COVID Bariatric, Hepato-Biliary and Colorectal surgery study
description: 30 Day Mortality after surgery in patients with COVID19 infection who undergo elective bariatric, hepato-biliary and colorectal surgery.
Patients diagnosed with COVID-19 at the time of surgery up to seven days before surgery
Patients diagnosed with COVID-19 within 30 days after surgery
intervention type: Other
intervention name: Treatment for COVID-19
description: Patients treated for COVID-19
arm group label: COVID-19 Cohort
arm group label: Synopsis for COVID Bariatric, Hepato-Biliary and Colorectal surgery study
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Crystee Cooper, DHEd
role: Principal Investigator
affiliation: Methodist Health System
last name: Crystee Cooper, DHEd
phone: 214-947-1285
email: clinicalresearch@mhd.com
last name: Zaid Haddadin, MS
phone: 214-947-4604
email: clinicalresearch@mhd.com
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No