<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/NCT04455451</url>
  </required_header>
  <id_info>
    <org_study_id>DCIR</org_study_id>
    <nct_id>NCT04455451</nct_id>
  </id_info>
  <brief_title>Intensive Care Therapy of Covid-19 Disease in Germany</brief_title>
  <official_title>Intensive Care Therapy of Covid-19 Disease in Germany an Multi-center Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Tuebingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Tuebingen</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>
      Multi-center retrospective and prospective observational study of Covid-19 patients with&#xD;
      severe or critical illness treated on a German ICU&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 6, 2020</start_date>
  <completion_date type="Actual">September 30, 2021</completion_date>
  <primary_completion_date type="Actual">August 15, 2021</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>up to 150 days</time_frame>
    <description>ICU Mortality of patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ICU length of stay</measure>
    <time_frame>up to 150 days</time_frame>
    <description>Intensive care unit length of stay</description>
  </secondary_outcome>
  <enrollment type="Actual">2054</enrollment>
  <condition>COVID</condition>
  <condition>ARDS</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adults admitted for ICU therapy due to severe or critical Covid-19&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age above 18 years&#xD;
&#xD;
          -  Covid-19 disease (positive SARS-CoV-2 PCR)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -none&#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>Peter Rosenberger, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Tübingen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Harry Magunia, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Tübingen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>RWTH Aachen - Department for operative Intensive Care Medicine and intermediate Care</name>
      <address>
        <city>Aachen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zollernalbklinikum</name>
      <address>
        <city>Balingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UH Bochum - Department for Anesthesiology and Intensive Care Medicine</name>
      <address>
        <city>Bochum</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Bonn</name>
      <address>
        <city>Bonn</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Carl Gustav Carus Dresden</name>
      <address>
        <city>Dresden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ev. Krankenhaus Bethesda Duisburg Klinik für Anästhesiologie und Intensivmedizin</name>
      <address>
        <city>Duisburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univerrsitätsklinikum Düsseldorf</name>
      <address>
        <city>Düsseldorf</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Essen</name>
      <address>
        <city>Essen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Frankfurt</name>
      <address>
        <city>Frankfurt</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Freiburg - Department for Anesthesiology and Intensive Care Medicine</name>
      <address>
        <city>Freiburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Giessen Klinik für Anaesthesiologie und operative Intensivmedizin</name>
      <address>
        <city>Gießen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Greifswald</name>
      <address>
        <city>Greifswald</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin Göttingen Klinik für Anästhesiologie</name>
      <address>
        <city>Göttingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Halle</name>
      <address>
        <city>Halle/Saale</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Heidelberg - Department for Anesthesiologie and Intensive Care Medicine</name>
      <address>
        <city>Heidelberg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum des Saarlandes</name>
      <address>
        <city>Homburg/Saar</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum der Universität Witten/Herdecke - Köln / Klinik für Anästhesiologie und operative Intensivmedizin</name>
      <address>
        <city>Köln</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Leipzig</name>
      <address>
        <city>Leipzig</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UKSH Campus Lübeck - Department for Anesthesiology and Intensive Care Medicine</name>
      <address>
        <city>Lübeck</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Magdeburg - Department for Anesthesiology and Intensive Care Medicine</name>
      <address>
        <city>Magdeburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Marburg</name>
      <address>
        <city>Marburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Technische Universität München</name>
      <address>
        <city>München</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oberschwabenklinik Ravensburg Klinik für Anästhesie-, Intensiv-, Notfall- und Schmerzmedizin</name>
      <address>
        <city>Ravensburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Tübingen - Department for Anesthesiology and Intensive Care Medicine</name>
      <address>
        <city>Tübingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Ulm</name>
      <address>
        <city>Ulm</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Würzburg Klinik und Poliklinik für Anästhesiologie, Intensivmedizin und Schmerztherapie</name>
      <address>
        <city>Würzburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>https://www.medizin.uni-tuebingen.de/de/covid-intensivstudie</url>
    <description>Study Landing Page</description>
  </link>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>January 11, 2022</last_update_submitted>
  <last_update_submitted_qc>January 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04455451
org study id: DCIR
nct id: NCT04455451
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Multi-center retrospective and prospective observational study of Covid-19 patients with
      severe or critical illness treated on a German ICU
observational model: Cohort
time perspective: Other
measure: Mortality
time frame: up to 150 days
description: ICU Mortality of patients
measure: ICU length of stay
time frame: up to 150 days
description: Intensive care unit length of stay
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter Rosenberger, MD, PhD
role: Principal Investigator
affiliation: University Hospital Tübingen
last name: Harry Magunia, MD
role: Principal Investigator
affiliation: University Hospital Tübingen
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
url: https://www.medizin.uni-tuebingen.de/de/covid-intensivstudie
description: Study Landing Page
responsible party type: Sponsor
sharing ipd: No