<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/NCT04405973</url>
  </required_header>
  <id_info>
    <org_study_id>EK-FR 329/20</org_study_id>
    <nct_id>NCT04405973</nct_id>
  </id_info>
  <brief_title>Clinical Scores for Outcome Prediction in Patients With Severe COVID-19 Pneumonia Requiring ECMO</brief_title>
  <official_title>Clinical Scores for Outcome Prediction in Patients With Severe COVID-19 Pneumonia Requiring Extracorporeal Membrane Oxygenation - a Retrospective Multi-center Registry Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. Alexander Supady</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Freiburg</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 prognosis of patients with severe COVID-19 disease, whose lungs are so severely diseased&#xD;
      that they need to be supported by veno-venous ECMO (extracorporeal membrane oxygenation), is&#xD;
      difficult to assess so far. Previously published data from studies, case reports and case&#xD;
      series describe a very high mortality in this patient collective. The significance of&#xD;
      established clinical prognostic cores in this patient population has not been systematically&#xD;
      investigated. This is aggravated by the fact that even at very specialized centers only very&#xD;
      few patients from this collective are (can be) treated, so that valid investigations are only&#xD;
      possible in a multicenter patient collective. In this registry study, all patients diagnosed&#xD;
      with COVID-19 and treated with vv-ECMO in the centers participating in the study should be&#xD;
      retrospectively examined. The primary aim of the study is to investigate 30-day survival,&#xD;
      secondary objectives include the analysis of different clinical scores at the time of ECMO&#xD;
      implantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In December 2019, a series of unexplained cases of pneumonia in the city of Wuhan in China&#xD;
      has come to light. In virologic analyses of samples from the patients' deep respiratory&#xD;
      tract, a novel coronavirus was isolated (first named 2019-nCoV, then SARS-CoV-2). The disease&#xD;
      spread rapidly in the city of Wuhan in early 2020 and soon beyond. On 30 January 2020, the&#xD;
      Director-General of the World Health Organization (WHO) declared the outbreak a public health&#xD;
      emergency of international concern, and on 11 March 2020, the World Health Organization&#xD;
      declared the virus a pandemic.&#xD;
&#xD;
      In humans, an infection with the virus can cause respiratory tract infections or even very&#xD;
      severe pneumonia - these often end fatally, especially in old and pre-diseased patients. Due&#xD;
      to the novelty of the virus, the data basis for therapy is very limited. To date, there are&#xD;
      no clinical data for an effective specific therapy, nor is there a vaccination against the&#xD;
      virus available, so that therapy, especially intensive care treatment for very severe&#xD;
      courses, must concentrate only on supportive treatment of lung failure and other&#xD;
      complications.&#xD;
&#xD;
      The virus is highly contagious and infection results in a relevant number of deaths. Due to&#xD;
      very uncertain data on the spread of the virus in the population, it is difficult to estimate&#xD;
      the mortality rate - the case fatality rate is about 4% based on the known case numbers.&#xD;
&#xD;
      In reports on the treatment of the first cases in Wuhan (Hubei Province, China) in January&#xD;
      2020, the need for intensive care treatment is described for about a quarter of the inpatient&#xD;
      cases, 10-17% had to be ventilated invasively, and veno-venous extracorporeal membrane&#xD;
      oxygenation (vv-ECMO) was necessary in 2-4% of the inpatient cases. Patients requiring ECMO&#xD;
      have a high mortality rate in the studies published, so far. Recommendations for initiation&#xD;
      of ECMO in COVID-19 are being developed, though under continuous review.&#xD;
&#xD;
      Currently, little is known to guide clinicians in the choice of patients eligible for ECMO in&#xD;
      COVID-19, nor about the best time point for initiation of ECMO or the value of established&#xD;
      clinical scores for the prediction of the outcome of patients.&#xD;
&#xD;
      The aim of the study is to investigate survival in COVID-19 patients requiring vv-ECMO&#xD;
      support. Furthermore, the accuracy of clinical scores, established in intensive care medicine&#xD;
      for the prediction of outcome in severely ill patients will be assessed. Finally, time to&#xD;
      extubation from ventilation and time to ECMO-explantation will be evaluated. The study design&#xD;
      is a single-arm retrospective multi-center registry; therefore, no comparator will be&#xD;
      evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 19, 2020</start_date>
  <completion_date type="Actual">September 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2020</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>overall survival</measure>
    <time_frame>30 days</time_frame>
    <description>time from ECMO-implantation to death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>duration of ECMO treatment</measure>
    <time_frame>30 days</time_frame>
    <description>time from ECMO-implantation to ECMO-explantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>duration of ventilation treatment</measure>
    <time_frame>30 days</time_frame>
    <description>time from ECMO-implantation to extubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>duration of initiation of ECMO treatment to ICU discharge</measure>
    <time_frame>30 days</time_frame>
    <description>time from ECMO-implantation to ICU-discharge</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">133</enrollment>
  <condition>COVID-19</condition>
  <condition>SARS-CoV 2</condition>
  <condition>Extracorporeal Membrane Oxygenation</condition>
  <condition>ARDS</condition>
  <arm_group>
    <arm_group_label>COVID-19 ARDS, vv-ECMO</arm_group_label>
    <description>All patients in the study centers with diagnosed COVID-19 infection (PCR proven) and treatment with vv-ECMO</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>vv-ECMO</intervention_name>
    <description>vv-ECMO required in severe COVID-19 ARDS</description>
    <arm_group_label>COVID-19 ARDS, vv-ECMO</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All COVID-19-patients treated on an ICU at the participating centers and requeiring vv-ECMo&#xD;
        support&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient admitted to ICU&#xD;
&#xD;
          -  initiation of vv-ECMO&#xD;
&#xD;
          -  definite SARS-CoV-2-infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexander Supady, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Clinic Freiburg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Clinic Freiburg</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>November 2, 2020</last_update_submitted>
  <last_update_submitted_qc>November 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Freiburg</investigator_affiliation>
    <investigator_full_name>Dr. Alexander Supady</investigator_full_name>
    <investigator_title>Attending Physician - Oberarzt</investigator_title>
  </responsible_party>
  <keyword>ECMO</keyword>
  <keyword>ARDS</keyword>
  <keyword>COVID-19</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Pneumonia</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/NCT04405973
org study id: EK-FR 329/20
nct id: NCT04405973
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The prognosis of patients with severe COVID-19 disease, whose lungs are so severely diseased
      that they need to be supported by veno-venous ECMO (extracorporeal membrane oxygenation), is
      difficult to assess so far. Previously published data from studies, case reports and case
      series describe a very high mortality in this patient collective. The significance of
      established clinical prognostic cores in this patient population has not been systematically
      investigated. This is aggravated by the fact that even at very specialized centers only very
      few patients from this collective are (can be) treated, so that valid investigations are only
      possible in a multicenter patient collective. In this registry study, all patients diagnosed
      with COVID-19 and treated with vv-ECMO in the centers participating in the study should be
      retrospectively examined. The primary aim of the study is to investigate 30-day survival,
      secondary objectives include the analysis of different clinical scores at the time of ECMO
      implantation.
In December 2019, a series of unexplained cases of pneumonia in the city of Wuhan in China
      has come to light. In virologic analyses of samples from the patients' deep respiratory
      tract, a novel coronavirus was isolated (first named 2019-nCoV, then SARS-CoV-2). The disease
      spread rapidly in the city of Wuhan in early 2020 and soon beyond. On 30 January 2020, the
      Director-General of the World Health Organization (WHO) declared the outbreak a public health
      emergency of international concern, and on 11 March 2020, the World Health Organization
      declared the virus a pandemic.

      In humans, an infection with the virus can cause respiratory tract infections or even very
      severe pneumonia - these often end fatally, especially in old and pre-diseased patients. Due
      to the novelty of the virus, the data basis for therapy is very limited. To date, there are
      no clinical data for an effective specific therapy, nor is there a vaccination against the
      virus available, so that therapy, especially intensive care treatment for very severe
      courses, must concentrate only on supportive treatment of lung failure and other
      complications.

      The virus is highly contagious and infection results in a relevant number of deaths. Due to
      very uncertain data on the spread of the virus in the population, it is difficult to estimate
      the mortality rate - the case fatality rate is about 4% based on the known case numbers.

      In reports on the treatment of the first cases in Wuhan (Hubei Province, China) in January
      2020, the need for intensive care treatment is described for about a quarter of the inpatient
      cases, 10-17% had to be ventilated invasively, and veno-venous extracorporeal membrane
      oxygenation (vv-ECMO) was necessary in 2-4% of the inpatient cases. Patients requiring ECMO
      have a high mortality rate in the studies published, so far. Recommendations for initiation
      of ECMO in COVID-19 are being developed, though under continuous review.

      Currently, little is known to guide clinicians in the choice of patients eligible for ECMO in
      COVID-19, nor about the best time point for initiation of ECMO or the value of established
      clinical scores for the prediction of the outcome of patients.

      The aim of the study is to investigate survival in COVID-19 patients requiring vv-ECMO
      support. Furthermore, the accuracy of clinical scores, established in intensive care medicine
      for the prediction of outcome in severely ill patients will be assessed. Finally, time to
      extubation from ventilation and time to ECMO-explantation will be evaluated. The study design
      is a single-arm retrospective multi-center registry; therefore, no comparator will be
      evaluated.
observational model: Cohort
time perspective: Retrospective
measure: overall survival
time frame: 30 days
description: time from ECMO-implantation to death
measure: duration of ECMO treatment
time frame: 30 days
description: time from ECMO-implantation to ECMO-explantation
measure: duration of ventilation treatment
time frame: 30 days
description: time from ECMO-implantation to extubation
measure: duration of initiation of ECMO treatment to ICU discharge
time frame: 30 days
description: time from ECMO-implantation to ICU-discharge
arm group label: COVID-19 ARDS, vv-ECMO
description: All patients in the study centers with diagnosed COVID-19 infection (PCR proven) and treatment with vv-ECMO
intervention type: Device
intervention name: vv-ECMO
description: vv-ECMO required in severe COVID-19 ARDS
arm group label: COVID-19 ARDS, vv-ECMO
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Alexander Supady, MD, MPH
role: Principal Investigator
affiliation: University Clinic Freiburg
facility: 
country: Germany
responsible party type: Sponsor-Investigator
investigator affiliation: University Hospital Freiburg
investigator full name: Dr. Alexander Supady
investigator title: Attending Physician - Oberarzt
mesh term: COVID-19
mesh term: Pneumonia
sharing ipd: No