<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/NCT04475211</url>
  </required_header>
  <id_info>
    <org_study_id>2020_54</org_study_id>
    <secondary_id>2020-A01514-35</secondary_id>
    <nct_id>NCT04475211</nct_id>
  </id_info>
  <brief_title>LILLE COVID RESEARCH NETWORK (Covid-19)</brief_title>
  <acronym>LICORNE</acronym>
  <official_title>Predictors of Mortality at Day 28 of Patients Treated at Lille University Hospital for COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</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>
      The Lille University Hospital developped a research objective common to all the services&#xD;
      which took care of patients, &quot;suspected patient&quot;, &quot;possible case&quot;, &quot;probable case&quot; or&#xD;
      &quot;confirmed case&quot; infected with SARS-CoV-2 by constituting a prospective and a retrospective&#xD;
      observational cohort which allowed pooling and sharing the resources and data collected. In&#xD;
      the next two years the prospective cohort will allow to continue inclusions in a standardized&#xD;
      way mainly for the constitution of a negative control group (excluded cases), to collect&#xD;
      biological samples which had not been collected in the retrospective cohort so that the&#xD;
      pathophysiology of the COVID-19 will be better apprehended as for example the inflammatory&#xD;
      response to the viral infection. Finally in case of a second epidemic wave in the Hauts De&#xD;
      France, it seems essential to have a defined research protocol which had already received all&#xD;
      the necessary authorizations to guarantee cutting-edge (or quality ) research in a center&#xD;
      like the Lille University Hospital.The aim objective of this study is to identify predictive&#xD;
      factors of mortality to day 28 infection to SARS-CoV-2 for patients under medical care for&#xD;
      the COVID-19 in the Lille University Hospital thanks to the constitution of an&#xD;
      epidemiological, clinical, biological, immunological, genetic, microbiological,&#xD;
      anatomopathologic, radiological, therapeutic database and so record the results of functional&#xD;
      exploration exams.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a retrospective and prospective observational monocentric cohort study designed to&#xD;
      identify predictors of mortality on day 28 in patients treated at the Lille University&#xD;
      Hospital for COVID-19.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 10, 2020</start_date>
  <completion_date type="Anticipated">August 2022</completion_date>
  <primary_completion_date type="Anticipated">August 2022</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients &quot;confirmed cases&quot; of SARS-CoV-2 infection who died at D28 of inclusion</measure>
    <time_frame>At 28 days</time_frame>
    <description>Identify predictors of mortality at day 28 in patients treated at the Lille University Hospital for COVID-19</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between Infection characteristics of patients at inclusion and all predictors for Covid-19</measure>
    <time_frame>At inclusion (day 0)</time_frame>
    <description>Describe, at inclusion, the epidemiological, clinical, biological, immunological, genetic, microbiological, radiological, therapeutic characteristics and the results of functional explorations of patients hospitalized in our center with SARS-CoV-2 infection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between evolution infection characteristics of patients during stay of hospitalisation and all predictors for Covid-19</measure>
    <time_frame>At inclusion ( day 0) ,at day 1 , day3±1, Day 5±1, day 7±1, day 9±2, day14±2, day30±3, at months 3±7 days and at months6±7days or until death</time_frame>
    <description>Describe the evolution of the characteristics the epidemiological, clinical, biological, immunological, genetic, microbiological, anatomopathological, radiological, therapeutic characteristics and the results of functional explorations of patients hospitalized in our center with SARS-CoV-2 infection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positivity for Covid-19 patients performed and all predictors for Covid-19</measure>
    <time_frame>At inclusion (day 0)</time_frame>
    <description>The diagnosis of disease is excluded or confirmed by qRT-PCR SARS-CoV-2 (respiratory samples, blood, stool...) and/or serology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between hospitalisation and all predictors for Covid-19</measure>
    <time_frame>At inclusion( Day 0)</time_frame>
    <description>Identify epidemiological, clinical, radiological, biological, immunological and genetic predictors of hospitalization in patients with SARS-CoV-2 infection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between risk factors measured at D0 for severe CoV-2 SARS infection and all predictors for Covid-19</measure>
    <time_frame>At 28 day</time_frame>
    <description>Identify epidemiological, clinical, radiological, biological, immunological and genetic predictors of sévère SARS-CoV-2 infection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between overall survival at Day 28 and all predictors for Covid-19</measure>
    <time_frame>At 28 day</time_frame>
    <description>Identify epidemiological, clinical, radiological, biological, immunological, genetic and therapeutic predictors of survival in patients with SARS-CoV-2 infection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of at least one complication related to COVID 19</measure>
    <time_frame>during hospitalization or during outpatient follow-up of &quot;confirmed case&quot; patients at Lille University Hospital (maximum observation period 6 months).</time_frame>
    <description>Death is a concurrent risk.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of the thrombosis complication related to COVID 19</measure>
    <time_frame>during hospitalization or during outpatient follow-up of &quot;confirmed case&quot; patients at Lille University Hospital (maximum observation period 6 months).</time_frame>
    <description>Death is a concurrent risk.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All type of co-infections</measure>
    <time_frame>At 6 months</time_frame>
    <description>Describe viral (other than SARS-CoV-2), bacterial and fungal co-infections in patients admitted for COVID disease 19. The appropriateness of the co-infection search is at the discretion of the clinician to fit the patient's history and clinical presentation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alteration of microbiota</measure>
    <time_frame>At 6 months</time_frame>
    <description>alterations in respiratory and digestive microbiotes and their evolution potentially associated with bacterial or fungal superinfection in the most severe patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biobanking for further analyses such as SARS-CoV2 studies</measure>
    <time_frame>At 6 months</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Sars-CoV2</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood, plasma, serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All adult &quot;suspect patient&quot;, &quot;possible case&quot;, &quot;probable case&quot; or &quot;confirmed case&quot; of an&#xD;
        SARS-CoV-2 infection admitted to Lille University Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult &quot;suspect patient&quot;, &quot;possible case&quot;, &quot;probable case&quot; or &quot;confirmed case&quot; of&#xD;
             an SARS-CoV-2 infection admitted to Lille University Hospital.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minor patient Patient under guardianship or curatorship Refusal to participate in the&#xD;
             study Patient for whom the collection of genetic non-opposition or consent is&#xD;
             impossible because of a language barrier with the patient himself or herself or with&#xD;
             his or her trusted person or close family.&#xD;
&#xD;
        Patient for whom the collection of genetic non-opposition or consent is impossible because&#xD;
        of his or her state of health at the time of inclusion in the study and for whom the&#xD;
        trusted person or close family member opposes participation in the study.&#xD;
&#xD;
        Translated with www.DeepL.com/Translator (free version)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marie-Charlotte CHOPIN, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marie-Charlotte CHOPIN, MD</last_name>
    <phone>0320445743</phone>
    <phone_ext>+33</phone_ext>
    <email>mariecharlotte.chopin@chru-lille.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hop Claude Huriez Chr Lille</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>0320445962</phone>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>November 17, 2020</last_update_submitted>
  <last_update_submitted_qc>November 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>fatality rate</keyword>
  <keyword>Inflammatory and autoimmune processes</keyword>
  <keyword>severity</keyword>
  <keyword>clinical features</keyword>
  <keyword>diagnostic (qRT-PCR or serology) methods</keyword>
  <keyword>thrombosis</keyword>
  <keyword>co-infection</keyword>
  <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>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/NCT04475211
org study id: 2020_54
secondary id: 2020-A01514-35
nct id: NCT04475211
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Lille University Hospital developped a research objective common to all the services
      which took care of patients, "suspected patient", "possible case", "probable case" or
      "confirmed case" infected with SARS-CoV-2 by constituting a prospective and a retrospective
      observational cohort which allowed pooling and sharing the resources and data collected. In
      the next two years the prospective cohort will allow to continue inclusions in a standardized
      way mainly for the constitution of a negative control group (excluded cases), to collect
      biological samples which had not been collected in the retrospective cohort so that the
      pathophysiology of the COVID-19 will be better apprehended as for example the inflammatory
      response to the viral infection. Finally in case of a second epidemic wave in the Hauts De
      France, it seems essential to have a defined research protocol which had already received all
      the necessary authorizations to guarantee cutting-edge (or quality ) research in a center
      like the Lille University Hospital.The aim objective of this study is to identify predictive
      factors of mortality to day 28 infection to SARS-CoV-2 for patients under medical care for
      the COVID-19 in the Lille University Hospital thanks to the constitution of an
      epidemiological, clinical, biological, immunological, genetic, microbiological,
      anatomopathologic, radiological, therapeutic database and so record the results of functional
      exploration exams.
This is a retrospective and prospective observational monocentric cohort study designed to
      identify predictors of mortality on day 28 in patients treated at the Lille University
      Hospital for COVID-19.
observational model: Cohort
time perspective: Retrospective
measure: Number of patients "confirmed cases" of SARS-CoV-2 infection who died at D28 of inclusion
time frame: At 28 days
description: Identify predictors of mortality at day 28 in patients treated at the Lille University Hospital for COVID-19
measure: Correlation between Infection characteristics of patients at inclusion and all predictors for Covid-19
time frame: At inclusion (day 0)
description: Describe, at inclusion, the epidemiological, clinical, biological, immunological, genetic, microbiological, radiological, therapeutic characteristics and the results of functional explorations of patients hospitalized in our center with SARS-CoV-2 infection.
measure: Correlation between evolution infection characteristics of patients during stay of hospitalisation and all predictors for Covid-19
time frame: At inclusion ( day 0) ,at day 1 , day3±1, Day 5±1, day 7±1, day 9±2, day14±2, day30±3, at months 3±7 days and at months6±7days or until death
description: Describe the evolution of the characteristics the epidemiological, clinical, biological, immunological, genetic, microbiological, anatomopathological, radiological, therapeutic characteristics and the results of functional explorations of patients hospitalized in our center with SARS-CoV-2 infection.
measure: Positivity for Covid-19 patients performed and all predictors for Covid-19
time frame: At inclusion (day 0)
description: The diagnosis of disease is excluded or confirmed by qRT-PCR SARS-CoV-2 (respiratory samples, blood, stool...) and/or serology.
measure: Correlation between hospitalisation and all predictors for Covid-19
time frame: At inclusion( Day 0)
description: Identify epidemiological, clinical, radiological, biological, immunological and genetic predictors of hospitalization in patients with SARS-CoV-2 infection.
measure: Correlation between risk factors measured at D0 for severe CoV-2 SARS infection and all predictors for Covid-19
time frame: At 28 day
description: Identify epidemiological, clinical, radiological, biological, immunological and genetic predictors of sévère SARS-CoV-2 infection.
measure: Correlation between overall survival at Day 28 and all predictors for Covid-19
time frame: At 28 day
description: Identify epidemiological, clinical, radiological, biological, immunological, genetic and therapeutic predictors of survival in patients with SARS-CoV-2 infection.
measure: Cumulative incidence of at least one complication related to COVID 19
time frame: during hospitalization or during outpatient follow-up of "confirmed case" patients at Lille University Hospital (maximum observation period 6 months).
description: Death is a concurrent risk.
measure: Cumulative incidence of the thrombosis complication related to COVID 19
time frame: during hospitalization or during outpatient follow-up of "confirmed case" patients at Lille University Hospital (maximum observation period 6 months).
description: Death is a concurrent risk.
measure: All type of co-infections
time frame: At 6 months
description: Describe viral (other than SARS-CoV-2), bacterial and fungal co-infections in patients admitted for COVID disease 19. The appropriateness of the co-infection search is at the discretion of the clinician to fit the patient's history and clinical presentation
measure: Alteration of microbiota
time frame: At 6 months
description: alterations in respiratory and digestive microbiotes and their evolution potentially associated with bacterial or fungal superinfection in the most severe patients
measure: Biobanking for further analyses such as SARS-CoV2 studies
time frame: At 6 months
Blood, plasma, serum
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marie-Charlotte CHOPIN, MD
role: Principal Investigator
affiliation: University Hospital, Lille
last name: Marie-Charlotte CHOPIN, MD
phone: 0320445743
phone ext: +33
email: mariecharlotte.chopin@chru-lille.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Undecided