<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/NCT04491214</url>
  </required_header>
  <id_info>
    <org_study_id>7890</org_study_id>
    <nct_id>NCT04491214</nct_id>
  </id_info>
  <brief_title>Post ICU Follow up in Patients With Severe SARS-CoV-2 Infection (Covid-19)</brief_title>
  <official_title>Post ICU Follow up in Patients With Severe SARS-CoV-2 Infection (Covid-19)</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>
      Patients affected by new coronavirus infectious disease (COVID) were mostly hospitalized in&#xD;
      ICU. This infection seems to cause widespread organ injury (i.e acute renal injury,&#xD;
      neurological disorders, pulmonary embolism,…). It is therefore necessary to provide a&#xD;
      framework for the follow up of patients. Moreover SARS-CoV-2 infection consequences remain&#xD;
      unknow at this time. Study hypothesis is that COVID alters determining factors (physical or&#xD;
      psychological) of quality of life after ICU hospitalisation. The aim of the study is to&#xD;
      assess quality of life 3 months after ICU hospitalization.&#xD;
&#xD;
      Secondary purposes of the study are 1) assessment of quality of life 6 months and the&#xD;
      evolution between the third and the sixth months after ICU hospitalization 2) description&#xD;
      patients care after 3 and 6 months ICU left and their clinical status 3) convening and&#xD;
      providing a &quot;platform&quot; within several physicians (neurologist, biologist, pneumologist…) will&#xD;
      be able to follow up patients and perform complementary investigations according to patients&#xD;
      injuries.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 24, 2020</start_date>
  <completion_date type="Actual">January 21, 2021</completion_date>
  <primary_completion_date type="Actual">January 21, 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>assess quality of life after severe COVID infection</measure>
    <time_frame>measured at 3 months after ICU left.</time_frame>
    <description>assess different dimensions of quality of life: physical and mentaland social dimensions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life and Clinical status</measure>
    <time_frame>measured at 3 and 6 months after ICU left.</time_frame>
    <description>Clinical status of patients and assessment of quality of life. collects crucial elements of care based on doctors' prescriptions</description>
  </secondary_outcome>
  <enrollment type="Actual">112</enrollment>
  <condition>Covid19</condition>
  <condition>Follow up</condition>
  <condition>Rehabilitation</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>quality of live assessment</intervention_name>
    <description>quality of live assessment 3 moth and 6 moth after ointensive care hospitalisation using SF36.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with severe SARS-Cov-2 hospitalized in intensive care.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Subject male or female ≥ 18 years old&#xD;
&#xD;
          -  Patient hospitalized in the anesthesia-resuscitation department of the NHC for&#xD;
             COVID-19 from March 1, 2020.&#xD;
&#xD;
          -  Patient (or his legal representative) having given his consent for the use of his data&#xD;
             for the purposes of this research.&#xD;
&#xD;
        exclusion criteria:&#xD;
&#xD;
          -  Subject not hospitalized in intensive care&#xD;
&#xD;
          -  Patient's refusal to participate in the study&#xD;
&#xD;
          -  Inability to give informed information to the subject (subject in an emergency,&#xD;
             difficulty understanding the subject, etc.)&#xD;
&#xD;
          -  Subject under low protection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hôpitaux Universitaires de Strasbourg (Nouvel Hôpital Civil)</name>
      <address>
        <city>Strasbourg</city>
        <zip>67117</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>February 11, 2021</last_update_submitted>
  <last_update_submitted_qc>February 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SARS-CoV-2</keyword>
  <keyword>Follow up</keyword>
  <keyword>Intensive care unit</keyword>
  <keyword>Cohort</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/NCT04491214
org study id: 7890
nct id: NCT04491214
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients affected by new coronavirus infectious disease (COVID) were mostly hospitalized in
      ICU. This infection seems to cause widespread organ injury (i.e acute renal injury,
      neurological disorders, pulmonary embolism,…). It is therefore necessary to provide a
      framework for the follow up of patients. Moreover SARS-CoV-2 infection consequences remain
      unknow at this time. Study hypothesis is that COVID alters determining factors (physical or
      psychological) of quality of life after ICU hospitalisation. The aim of the study is to
      assess quality of life 3 months after ICU hospitalization.

      Secondary purposes of the study are 1) assessment of quality of life 6 months and the
      evolution between the third and the sixth months after ICU hospitalization 2) description
      patients care after 3 and 6 months ICU left and their clinical status 3) convening and
      providing a "platform" within several physicians (neurologist, biologist, pneumologist…) will
      be able to follow up patients and perform complementary investigations according to patients
      injuries.
observational model: Cohort
time perspective: Prospective
measure: assess quality of life after severe COVID infection
time frame: measured at 3 months after ICU left.
description: assess different dimensions of quality of life: physical and mentaland social dimensions
measure: Quality of life and Clinical status
time frame: measured at 3 and 6 months after ICU left.
description: Clinical status of patients and assessment of quality of life. collects crucial elements of care based on doctors' prescriptions
intervention type: Other
intervention name: quality of live assessment
description: quality of live assessment 3 moth and 6 moth after ointensive care hospitalisation using SF36.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Undecided