<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/NCT04492267</url>
  </required_header>
  <id_info>
    <org_study_id>7930</org_study_id>
    <nct_id>NCT04492267</nct_id>
  </id_info>
  <brief_title>Inflammatory Bowel Disease (IBD) and Covid-19 Infection</brief_title>
  <acronym>MICI-Covid-19</acronym>
  <official_title>SARS-CoV-2 Infection in Patients From Two Tertiary Inflammatory Bowel Disease (IBD) Centres: Frequency of Suspected and Confirmed Infections, Severity and Outcome Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Strasbourg, France</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>
      Most of the inflammatory bowel disease (IBD: Crohn's disease and ulcerative colitis) in a&#xD;
      tertiary expert Centre are on immunosuppressive and/or biological therapy. Theoretically,&#xD;
      these treatments may increase patients' risk of infection, in particular viral infection.&#xD;
      Therefore, the current SARS-Cov-2 pandemia, with its unprecedent worldwide morbidity and&#xD;
      mortality, may have a negative impact on IBD patients' clinical course. Identifying an&#xD;
      increased risk in this particular patients' population as well as the risk/protective factors&#xD;
      is of outstanding importance, in order to adapt their treatment and surveillance. As a&#xD;
      consequence, our aims were (i) to measure retrospectively the risk of SARS-CoV-2 (proven by&#xD;
      biological testing or suspected due to record of potential clinical symptoms of COVID-19&#xD;
      infection) in this patients' cohort (principal objective), (ii) to identify risk or&#xD;
      protective factors for SARS-CoV-2 infection in IBD, and (iii) to analyze the outcome of&#xD;
      patients in case of suspected or confirmed COVID-19. The results of this study may be&#xD;
      important to adjust our surveillance and therapeutic strategy in these patients, in&#xD;
      particular if high virus circulation will occur in the future.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 7, 2020</start_date>
  <completion_date type="Anticipated">January 7, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 7, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Retrospective analysis of severity and specific needs in case of SARS-CoV-2 infection in IBD patients</measure>
    <time_frame>Files analysed retrospectily from March 1st, 2020 to July 31, 2020 will be examined</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">700</enrollment>
  <condition>Inflammatory Bowel Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        IBD patient (Crohn's disease, ulcerative colitis, indeterminate colitis) over the age of 18&#xD;
        years&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient over the age of 18 years&#xD;
&#xD;
          -  IBD patients (Crohn's disease, ulcerative colitis, indeterminate colitis)&#xD;
&#xD;
          -  Patient agreeing to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient unable to understand the study protocol or to answer simple anamnestic&#xD;
             questions due to language barrier&#xD;
&#xD;
          -  Patient under guardianship or trusteeship&#xD;
&#xD;
          -  Patient under safeguard of justice&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Jean-Marie REIMUND, MD, PhD</last_name>
    <phone>33 3 88 12 74 41</phone>
    <email>jean-marie.reimund@chru-strasbourg.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Saïd CHAYER, PhD, HDR</last_name>
    <phone>33 3 88 11 66 90</phone>
    <email>said.chayer@chru-strasbourg.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Service Hépato-Gastroentérologie et Assistance Nutritive Hôpitaux Univesitaires de Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-Marie REIMUND, MD, PhD</last_name>
      <phone>33 3 88 12 74 41</phone>
      <email>jean-marie.reimund@chru-strasbourg.fr</email>
    </contact>
    <investigator>
      <last_name>Jean-Marie REIMUND, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bénédicte CARON, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yves ARONDEL, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SARS-CoV-2</keyword>
  <keyword>Inflammatory Bowel Disease</keyword>
  <keyword>IBD</keyword>
  <keyword>Crohn's disease</keyword>
  <keyword>Ulcerative colitis</keyword>
  <keyword>Immunosuppressant therapy</keyword>
  <keyword>Biologicals</keyword>
  <keyword>Severe respiratory disease</keyword>
  <keyword>intensive care unit</keyword>
  <keyword>Mechanical ventilation</keyword>
  <keyword>Death</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT04492267
org study id: 7930
nct id: NCT04492267
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Most of the inflammatory bowel disease (IBD: Crohn's disease and ulcerative colitis) in a
      tertiary expert Centre are on immunosuppressive and/or biological therapy. Theoretically,
      these treatments may increase patients' risk of infection, in particular viral infection.
      Therefore, the current SARS-Cov-2 pandemia, with its unprecedent worldwide morbidity and
      mortality, may have a negative impact on IBD patients' clinical course. Identifying an
      increased risk in this particular patients' population as well as the risk/protective factors
      is of outstanding importance, in order to adapt their treatment and surveillance. As a
      consequence, our aims were (i) to measure retrospectively the risk of SARS-CoV-2 (proven by
      biological testing or suspected due to record of potential clinical symptoms of COVID-19
      infection) in this patients' cohort (principal objective), (ii) to identify risk or
      protective factors for SARS-CoV-2 infection in IBD, and (iii) to analyze the outcome of
      patients in case of suspected or confirmed COVID-19. The results of this study may be
      important to adjust our surveillance and therapeutic strategy in these patients, in
      particular if high virus circulation will occur in the future.
observational model: Case-Only
time perspective: Retrospective
measure: Retrospective analysis of severity and specific needs in case of SARS-CoV-2 infection in IBD patients
time frame: Files analysed retrospectily from March 1st, 2020 to July 31, 2020 will be examined
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Jean-Marie REIMUND, MD, PhD
phone: 33 3 88 12 74 41
email: jean-marie.reimund@chru-strasbourg.fr
last name: Saïd CHAYER, PhD, HDR
phone: 33 3 88 11 66 90
email: said.chayer@chru-strasbourg.fr
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases