<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/NCT04410484</url>
  </required_header>
  <id_info>
    <org_study_id>284920</org_study_id>
    <nct_id>NCT04410484</nct_id>
  </id_info>
  <brief_title>PREPARE-IBD: Physician Responses to Disease Flares and Patient Adaptation in Relation to Events in Inflammatory Bowel Disease During COVID-19 Pandemic</brief_title>
  <acronym>PREPARE IBD</acronym>
  <official_title>PREPARE-IBD: Physician Responses to Disease Flares and Patient Adaptation in Relation to Events in Inflammatory Bowel Disease During COVID-19 Pandemic</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>
      To find out what adaptations have been made by Inflammatory bowel disease physicians and&#xD;
      patients in relation to therapies in flaring IBD patients during severe acute respiratory&#xD;
      syndrome 2-COV and what the impact of these is on IBD patients with no symptomatic COVID-19&#xD;
      and in suspected/confirmed COVID-19. Also whether there any IBD related factors impacting the&#xD;
      outcome of patients with COVID-19 symptoms or COVID-19 disease&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An observational, retrospective, case-controlled study to determine the status of IBD during&#xD;
      development of COVID-19 symptoms/positive COVID-19. The aim is to describe the adaptations in&#xD;
      therapies for active IBD during SARS COV 2 in patients with active IBD and positive or&#xD;
      negative COVID-19 symptoms. It will evaluate IBD outcomes following development of COVID-19&#xD;
      symptoms / positive COVID-19 and determine any predictors of outcomes in IBD patients with&#xD;
      COVID-19 symptoms / positive COVID-19 as well as determine the impact on IBD outcomes&#xD;
      resulting from adaptations to treatments during COVID-19&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 22, 2020</start_date>
  <completion_date type="Actual">August 31, 2022</completion_date>
  <primary_completion_date type="Actual">August 31, 2022</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>Flare of IBD needing change in therapy or surgery</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">3728</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <condition>Coronavirus Infection</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <description>Admitted patients with IBD (with IBD OR due to COVID) whether tested or not tested for COVID between 1st March and 30th June 2020</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2</arm_group_label>
    <description>Patients with IBD self-isolating with suggestive COVID19 symptoms (Fever or persistent Cough) or tested positive for COVID19 during same period</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3</arm_group_label>
    <description>Patients with active IBD identified during the same study period. (definition: increased symptoms suggestive of flare, raised calprotectin, raised CRP, endoscopy or imaging during the previous 6 weeks showing active disease and contacted/reviewed during the study period , admission with IBD ( These will be identified through your helpline/ virtual clinics/Hot clinics/flare lines</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <description>Consecutive patients with active IBD between 1st March 2019-30th June 2019</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        About 1 in 100- to 1 in 200 patients have IBD and up to 550,000 patients are estimated in&#xD;
        the UK.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with IBD +/- flare +/- COVID 19 positivity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients below 16&#xD;
&#xD;
          -  Patient with inactive IBD&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shaji Sebastian</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hull and East Yorkshire NHS Trust</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.ncbi.nlm.nih.gov/pmc/articles/PMC9383326/</url>
    <description>Resulting publication</description>
  </link>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>November 1, 2022</last_update_submitted>
  <last_update_submitted_qc>November 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 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>Coronavirus Infections</mesh_term>
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Intestinal Diseases</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/NCT04410484
org study id: 284920
nct id: NCT04410484
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To find out what adaptations have been made by Inflammatory bowel disease physicians and
      patients in relation to therapies in flaring IBD patients during severe acute respiratory
      syndrome 2-COV and what the impact of these is on IBD patients with no symptomatic COVID-19
      and in suspected/confirmed COVID-19. Also whether there any IBD related factors impacting the
      outcome of patients with COVID-19 symptoms or COVID-19 disease
An observational, retrospective, case-controlled study to determine the status of IBD during
      development of COVID-19 symptoms/positive COVID-19. The aim is to describe the adaptations in
      therapies for active IBD during SARS COV 2 in patients with active IBD and positive or
      negative COVID-19 symptoms. It will evaluate IBD outcomes following development of COVID-19
      symptoms / positive COVID-19 and determine any predictors of outcomes in IBD patients with
      COVID-19 symptoms / positive COVID-19 as well as determine the impact on IBD outcomes
      resulting from adaptations to treatments during COVID-19
observational model: Case-Control
time perspective: Retrospective
measure: Flare of IBD needing change in therapy or surgery
time frame: 3 months
arm group label: 1
description: Admitted patients with IBD (with IBD OR due to COVID) whether tested or not tested for COVID between 1st March and 30th June 2020
arm group label: 2
description: Patients with IBD self-isolating with suggestive COVID19 symptoms (Fever or persistent Cough) or tested positive for COVID19 during same period
arm group label: 3
description: Patients with active IBD identified during the same study period. (definition: increased symptoms suggestive of flare, raised calprotectin, raised CRP, endoscopy or imaging during the previous 6 weeks showing active disease and contacted/reviewed during the study period , admission with IBD ( These will be identified through your helpline/ virtual clinics/Hot clinics/flare lines
arm group label: Control Group
description: Consecutive patients with active IBD between 1st March 2019-30th June 2019
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Shaji Sebastian
role: Principal Investigator
affiliation: Hull and East Yorkshire NHS Trust
facility: 
country: United Kingdom
url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9383326/
description: Resulting publication
responsible party type: Sponsor
mesh term: Coronavirus Infections
mesh term: COVID-19
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases
sharing ipd: Undecided