<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/NCT04411784</url>
  </required_header>
  <id_info>
    <org_study_id>284030</org_study_id>
    <nct_id>NCT04411784</nct_id>
  </id_info>
  <brief_title>PROTECT-ASUC: Covid-19 Pandemic Response Of assessmenT, EndosCopy and Treatment in Acute Severe Ulcerative Colitis</brief_title>
  <acronym>PROTECT-ASUC</acronym>
  <official_title>PROTECT-ASUC: Covid-19 Pandemic Response Of assessmenT, EndosCopy and Treatment in Acute Severe Ulcerative Colitis: A Multi-centre Observational Case- Control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hull University Teaching Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hull University Teaching Hospitals NHS Trust</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>
      Whether the perceived changes in management of Acute Severe Ulcerative Colitis during the&#xD;
      COVID pandemic are widespread, and whether they have any impact on patient outcomes&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study aims to evaluate the process, evaluation and therapy variation in management of&#xD;
      ASUC with reference to 2019 British Society of Gastroenterology guidelines and see whether&#xD;
      there are any differences between ambulatory and hospital management in ASUC. Also to&#xD;
      evaluate the outcomes in ASUC patients managed during the COVID-19 pandemic&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 20, 2020</start_date>
  <completion_date type="Actual">August 31, 2020</completion_date>
  <primary_completion_date type="Actual">August 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Primary outcome measure: The need for in-hospital colectomy or rescue therapy</measure>
    <time_frame>3 months</time_frame>
    <description>The need for in-hospital colectomy or rescue therapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>2.1: Duration and type/route of steroid use</measure>
    <time_frame>3 months</time_frame>
    <description>Duration and type/route of steroid use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2.2: 30 day colectomy free survival rates</measure>
    <time_frame>3 months</time_frame>
    <description>30 day colectomy free survival rates</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2.3: Covid-19 infection rates</measure>
    <time_frame>3 months</time_frame>
    <description>Covid-19 infection rates</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2.4: Rate of Rescue therapy use</measure>
    <time_frame>3 months</time_frame>
    <description>Rate of Rescue therapy use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2.5: Duration of hospital stay</measure>
    <time_frame>3 months</time_frame>
    <description>Duration of hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2.6: Admission severity scoring</measure>
    <time_frame>3 months</time_frame>
    <description>Admission severity scoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2.7: Readmission rates</measure>
    <time_frame>3 months</time_frame>
    <description>Readmission rates</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">10</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <condition>COVID</condition>
  <arm_group>
    <arm_group_label>Main group</arm_group_label>
    <description>Patient with Acute Severe Ulcerative Colitis based on Modified Truelove and Witts Severity Index managed during the study period</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <description>Patients with ASUC managed in the unit from 1st Jan to 31st June 2019</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        In The UK alone approximately 6500 patients are admitted with ASUC each year&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 16 -100 inclusive&#xD;
&#xD;
          -  Acute Severe Ulcerative Colitis based on Modified Truelove and Witts Severity Index&#xD;
             managed during the study period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients aged 16 -100 inclusive&#xD;
&#xD;
          -  Acute Severe Ulcerative Colitis based on Modified Truelove and Witts Severity Index&#xD;
             managed during the study period&#xD;
&#xD;
               -  Admission for elective colectomy&#xD;
&#xD;
               -  Pouch or stoma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Shaji Sebastian</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hull University Teaching Hospitals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gastroenterology, Hull Royal Infirmary, Hull University Teaaching Hospitals NHS Trust</name>
      <address>
        <city>Hull</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://www.crohnsandcolitis.org.uk/support/coronavirus/research-into-the-coronavirus-and-crohns-and-colitis/prepare-ibd</url>
    <description>Study-dedicated website</description>
  </link>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>November 3, 2022</last_update_submitted>
  <last_update_submitted_qc>November 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2022</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>Colitis</mesh_term>
    <mesh_term>Colitis, Ulcerative</mesh_term>
    <mesh_term>Inflammatory Bowel 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/NCT04411784
org study id: 284030
nct id: NCT04411784
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Whether the perceived changes in management of Acute Severe Ulcerative Colitis during the
      COVID pandemic are widespread, and whether they have any impact on patient outcomes
The study aims to evaluate the process, evaluation and therapy variation in management of
      ASUC with reference to 2019 British Society of Gastroenterology guidelines and see whether
      there are any differences between ambulatory and hospital management in ASUC. Also to
      evaluate the outcomes in ASUC patients managed during the COVID-19 pandemic
observational model: Case-Control
time perspective: Retrospective
measure: Primary outcome measure: The need for in-hospital colectomy or rescue therapy
time frame: 3 months
description: The need for in-hospital colectomy or rescue therapy
measure: 2.1: Duration and type/route of steroid use
time frame: 3 months
description: Duration and type/route of steroid use
measure: 2.2: 30 day colectomy free survival rates
time frame: 3 months
description: 30 day colectomy free survival rates
measure: 2.3: Covid-19 infection rates
time frame: 3 months
description: Covid-19 infection rates
measure: 2.4: Rate of Rescue therapy use
time frame: 3 months
description: Rate of Rescue therapy use
measure: 2.5: Duration of hospital stay
time frame: 3 months
description: Duration of hospital stay
measure: 2.6: Admission severity scoring
time frame: 3 months
description: Admission severity scoring
measure: 2.7: Readmission rates
time frame: 3 months
description: Readmission rates
arm group label: Main group
description: Patient with Acute Severe Ulcerative Colitis based on Modified Truelove and Witts Severity Index managed during the study period
arm group label: Control Group
description: Patients with ASUC managed in the unit from 1st Jan to 31st June 2019
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: 100 Years
last name: Shaji Sebastian
role: Principal Investigator
affiliation: Hull University Teaching Hospitals
facility: 
country: United Kingdom
url: https://www.crohnsandcolitis.org.uk/support/coronavirus/research-into-the-coronavirus-and-crohns-and-colitis/prepare-ibd
description: Study-dedicated website
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Inflammatory Bowel Diseases
sharing ipd: Undecided