<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/NCT04401111</url>
  </required_header>
  <id_info>
    <org_study_id>20reamedcovid04</org_study_id>
    <nct_id>NCT04401111</nct_id>
  </id_info>
  <brief_title>One-year Outcomes in Survivors of the Severe COVID-19 Pneumonia (CO-Qo-ICU)</brief_title>
  <acronym>CO-Qo-ICU</acronym>
  <official_title>Multiparametric Evaluation of One-year Outcomes in Survivors of the Severe COVID-19 Pneumonia After Intensive Care Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nice</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nice</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>
      Many of the patients hospitalized for a severe form of SARSCoV-2 respiratory impairment&#xD;
      require prolonged intensive care that can be complicated in the short term, In the medium and&#xD;
      long term, physical and psychological sequelae can affect patients' quality of life and&#xD;
      prevent a return to normal working life.&#xD;
&#xD;
      To date, there is little data on the fate of patients treated in Resuscitation for a severe&#xD;
      form of COVID-19, both in terms of respiratory sequelae, as well as in terms of psychological&#xD;
      sequelae and their quality of life. The objective of this study is to be able to describe and&#xD;
      evaluate the possible physical and psychological sequelae and quality of life of patients&#xD;
      hospitalized in Resuscitation for a severe form of COVID-19 in the short (3 and 6 months),&#xD;
      medium (1 year) and long (5 years) End of their stay in ICU. To do this, we want to carry out&#xD;
      a prospective, observational and monocentric study in the consultation department of the Nice&#xD;
      CHU. All patients admitted to Resuscitation for a severe form of COVID-19 who have accepted&#xD;
      the longitudinal medical follow-up proposed by the Nice CHU will be included in the study and&#xD;
      data from the computerized medical record will be analyzed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 16, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2025</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>Quality of life assessment at 3 months of stay in ICU patients hospitalized for a severe form of COVID-19</measure>
    <time_frame>5 years</time_frame>
    <description>SF-36 score calculation at 3 months of inpatient ICU stay for severe COVID-19</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Assessment at 6 months, 1 year and 5 years of Inpatient Resuscitation for severe COVID-19</measure>
    <time_frame>5 years</time_frame>
    <description>Quality of Life Assessment at 6 months, 1 year and 5 years of Inpatient Resuscitation for severe COVID-19</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of respiratory function and lung lesions at 3 months, 6 months, 1 year and 5 years of hospitalized patients in ICU for severe COVID-19.</measure>
    <time_frame>5 years</time_frame>
    <description>Vital and total lung capacity measurement when performing respiratory functional scans</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stress-based assessment of respiratory function at 3 months, 6 months, 1 year and 5 years of hospitalized ICU for severe COVID-19</measure>
    <time_frame>5 years</time_frame>
    <description>Measurement of the extent of pulmonary parenchymal lesions when performing a chest CT scan at 3 months, 6 months, 1 year and 5 years of hospitalized patients in ICU for severe COVID-19</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of resuscitation neuromyopathy at 3 months, 6 months, 1 year and 5 years of hospitalized patients in Resuscitation for severe COVID-19</measure>
    <time_frame>5 years</time_frame>
    <description>Measurement of CKD score at 3 months, 6 months, 1 year and 5 years of hospitalized patient ICU for severe COVID-19. This score described in Appendix 2 is the recommended score for assessing resuscitation neuromyopathy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left and Right Cardiac Function Assessment at 3 months, 6 months, 1 year and 5 years of Inpatient Resuscitation for severe COVID-19</measure>
    <time_frame>5 years</time_frame>
    <description>Measurement of left and right ventricular ejection fraction when performing a transthoracic cardiac ultrasound at 3 months, 6 months, 1 year and 5 years of hospitalized ICU for a severe form of COVID-19</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological evaluation at 3 months, 6 months, 1 year and 5 years of stay in Intensive Care for patients hospitalized for a serious form of COVID-19</measure>
    <time_frame>5 years</time_frame>
    <description>Evaluation des scores IES-R (Impact of Event Scale Revised) et HAD (Hospital Anxiety and Depression scale)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the possible impact on professional activity at 3 months, 6 months, 1 year and 5 years of stay in Intensive Care for patients hospitalized for a serious form of COVID-19</measure>
    <time_frame>5 years</time_frame>
    <description>Measure the return to work rate (full-time, half-time, &lt;half-time, none) at 3 months, 6 months, 1 year and 5 years of hospitalized Resuscitation for severe COVID-19.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the 3-month, 6-month, 1-year and 5-year hospitalization rate for hospitalized patients with severe COVID-19.</measure>
    <time_frame>5 years</time_frame>
    <description>The number of hospitalizations and the number of days spent in hospital at 3 months, 6 months, 1 year and 5 years of hospitalized patients in ICU for severe COVID-19.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>COVID</condition>
  <condition>ARDS</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Survivors of Intensive care unit patients</arm_group_label>
    <description>Survivors of severe COVID-19 pneumonia after intensive care unit</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients treated for COVID-19 in Intensive care unit&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients hospitalized in ICU for an ARDS table&#xD;
&#xD;
          -  PCR SARSCoV-2 nasopharyngeal or positive pulmonary samples&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Clément SACCHERI</last_name>
    <phone>0033492035510</phone>
    <email>saccheri.c@chu-nice.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jean DELLAMONICA, MD, PhD</last_name>
    <phone>0033492035510</phone>
    <email>dellamonica.j@chu-nice.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU de Nice</name>
      <address>
        <city>Nice</city>
        <zip>06200</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clément SACCHERI</last_name>
      <email>saccheri.c@chu-nice.fr</email>
    </contact>
    <contact_backup>
      <last_name>Jean DELLAMONICA</last_name>
      <email>dellamonica.j@chu-nice.fr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>October 17, 2022</last_update_submitted>
  <last_update_submitted_qc>October 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Long term prognosis</keyword>
  <keyword>Six-minute walk test</keyword>
  <keyword>Restrictive syndrom</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No Data sharing plan has been established</ipd_description>
  </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/NCT04401111
org study id: 20reamedcovid04
nct id: NCT04401111
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Many of the patients hospitalized for a severe form of SARSCoV-2 respiratory impairment
      require prolonged intensive care that can be complicated in the short term, In the medium and
      long term, physical and psychological sequelae can affect patients' quality of life and
      prevent a return to normal working life.

      To date, there is little data on the fate of patients treated in Resuscitation for a severe
      form of COVID-19, both in terms of respiratory sequelae, as well as in terms of psychological
      sequelae and their quality of life. The objective of this study is to be able to describe and
      evaluate the possible physical and psychological sequelae and quality of life of patients
      hospitalized in Resuscitation for a severe form of COVID-19 in the short (3 and 6 months),
      medium (1 year) and long (5 years) End of their stay in ICU. To do this, we want to carry out
      a prospective, observational and monocentric study in the consultation department of the Nice
      CHU. All patients admitted to Resuscitation for a severe form of COVID-19 who have accepted
      the longitudinal medical follow-up proposed by the Nice CHU will be included in the study and
      data from the computerized medical record will be analyzed.
observational model: Cohort
time perspective: Prospective
measure: Quality of life assessment at 3 months of stay in ICU patients hospitalized for a severe form of COVID-19
time frame: 5 years
description: SF-36 score calculation at 3 months of inpatient ICU stay for severe COVID-19
measure: Quality of Life Assessment at 6 months, 1 year and 5 years of Inpatient Resuscitation for severe COVID-19
time frame: 5 years
description: Quality of Life Assessment at 6 months, 1 year and 5 years of Inpatient Resuscitation for severe COVID-19
measure: Assessment of respiratory function and lung lesions at 3 months, 6 months, 1 year and 5 years of hospitalized patients in ICU for severe COVID-19.
time frame: 5 years
description: Vital and total lung capacity measurement when performing respiratory functional scans
measure: Stress-based assessment of respiratory function at 3 months, 6 months, 1 year and 5 years of hospitalized ICU for severe COVID-19
time frame: 5 years
description: Measurement of the extent of pulmonary parenchymal lesions when performing a chest CT scan at 3 months, 6 months, 1 year and 5 years of hospitalized patients in ICU for severe COVID-19
measure: Assessment of resuscitation neuromyopathy at 3 months, 6 months, 1 year and 5 years of hospitalized patients in Resuscitation for severe COVID-19
time frame: 5 years
description: Measurement of CKD score at 3 months, 6 months, 1 year and 5 years of hospitalized patient ICU for severe COVID-19. This score described in Appendix 2 is the recommended score for assessing resuscitation neuromyopathy
measure: Left and Right Cardiac Function Assessment at 3 months, 6 months, 1 year and 5 years of Inpatient Resuscitation for severe COVID-19
time frame: 5 years
description: Measurement of left and right ventricular ejection fraction when performing a transthoracic cardiac ultrasound at 3 months, 6 months, 1 year and 5 years of hospitalized ICU for a severe form of COVID-19
measure: Psychological evaluation at 3 months, 6 months, 1 year and 5 years of stay in Intensive Care for patients hospitalized for a serious form of COVID-19
time frame: 5 years
description: Evaluation des scores IES-R (Impact of Event Scale Revised) et HAD (Hospital Anxiety and Depression scale)
measure: Evaluation of the possible impact on professional activity at 3 months, 6 months, 1 year and 5 years of stay in Intensive Care for patients hospitalized for a serious form of COVID-19
time frame: 5 years
description: Measure the return to work rate (full-time, half-time, <half-time, none) at 3 months, 6 months, 1 year and 5 years of hospitalized Resuscitation for severe COVID-19.
measure: Assessment of the 3-month, 6-month, 1-year and 5-year hospitalization rate for hospitalized patients with severe COVID-19.
time frame: 5 years
description: The number of hospitalizations and the number of days spent in hospital at 3 months, 6 months, 1 year and 5 years of hospitalized patients in ICU for severe COVID-19.
arm group label: Survivors of Intensive care unit patients
description: Survivors of severe COVID-19 pneumonia after intensive care unit
Whole blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Clément SACCHERI
phone: 0033492035510
email: saccheri.c@chu-nice.fr
last name: Jean DELLAMONICA, MD, PhD
phone: 0033492035510
email: dellamonica.j@chu-nice.fr
facility: 
status: Recruiting
contact: 
contact backup: 
country: France
responsible party type: Sponsor
mesh term: Pneumonia
sharing ipd: No
ipd description: No Data sharing plan has been established