<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/NCT04412460</url>
  </required_header>
  <id_info>
    <org_study_id>CovidEcho</org_study_id>
    <nct_id>NCT04412460</nct_id>
  </id_info>
  <brief_title>Echocardiography in Patients With Covid-19</brief_title>
  <official_title>Echocardiography in Patients With Covid-19 Undergoing Intensive Care Therapy</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>
      Prospective observational study of patients treated due to Covid-19 disease. Observation and&#xD;
      analysis of echocardiographic studies performed in the intensive care setting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Not feasible.&#xD;
  </why_stopped>
  <start_date type="Actual">March 20, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>ICU Mortality</measure>
    <time_frame>up to 90 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>ICU length-of stay</measure>
    <time_frame>up to 90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU ventilator free days</measure>
    <time_frame>up to 90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length-of-stay</measure>
    <time_frame>up to 90 days</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>COVID</condition>
  <condition>ARDS, Human</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adults admitted for ICU therapy due to severe 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&#xD;
&#xD;
          -  invasive Ventilation&#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>
  <location>
    <facility>
      <name>University Hospital Tubingen</name>
      <address>
        <city>Tubingen</city>
        <state>BW</state>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>September 23, 2021</last_update_submitted>
  <last_update_submitted_qc>September 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2021</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>Respiratory Distress Syndrome</mesh_term>
  </condition_browse>
  <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/NCT04412460
org study id: CovidEcho
nct id: NCT04412460
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective observational study of patients treated due to Covid-19 disease. Observation and
      analysis of echocardiographic studies performed in the intensive care setting.
observational model: Cohort
time perspective: Prospective
measure: ICU Mortality
time frame: up to 90 days
measure: ICU length-of stay
time frame: up to 90 days
measure: ICU ventilator free days
time frame: up to 90 days
measure: Hospital length-of-stay
time frame: up to 90 days
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Respiratory Distress Syndrome
sharing ipd: No