<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/NCT04422340</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL20_0386</org_study_id>
    <nct_id>NCT04422340</nct_id>
  </id_info>
  <brief_title>Senior-COVID-Rea Multicentric Survey</brief_title>
  <acronym>SeniorCOVIDRea</acronym>
  <official_title>A Multicentric Survey on Patients Over 60 Admitted to Intensive Care for Severe Forms of COVID Infection: Search for Prognostic Criteria Associated With Survival</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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>
      With the spread of COVID-19 epidemic since 2019 in Wuhan, China health plans have to be&#xD;
      adapted continuously in response to the emergency. The first publications from the Chinese&#xD;
      experience demonstrate an increase in the incidence of COVID-19 infections in patients over&#xD;
      60 years of age, a higher frequency of severe forms of the disease and therefore theoretical&#xD;
      indications of orientation towards resuscitative care.&#xD;
&#xD;
      However, the first published data from Hubei province suggest a low benefit of resuscitation&#xD;
      for patients between 70 and 80 years of age and null in patients over 80 years of age. These&#xD;
      data question the individual benefit / risk balance of an orientation towards resuscitation&#xD;
      for this category of patients, their quality of life and the concept of unreasonable&#xD;
      obstinacy.&#xD;
&#xD;
      Among the covariates associated with resuscitation mortality described in the data published&#xD;
      to date, cardiovascular comorbidities, certain biological covariates (LDH, creatinine,&#xD;
      lymphocytes, neutrophils, TP, D-dimers, etc.), the time between the first symptoms and the&#xD;
      entry into resuscitation have been identified.&#xD;
&#xD;
      The objective of this multicentric observational study is to determine the clinical and&#xD;
      biological covariates predictive of mortality in the population of patients over 60 years of&#xD;
      age admitted in intensive care unit, in particular by integrating functional and nutritional&#xD;
      data from patients 1 month before COVID-19 infection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2020</start_date>
  <completion_date type="Anticipated">August 15, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 15, 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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of the impact of age on mortality at 30 days after admission to intensive care</measure>
    <time_frame>30 days after resuscitation admission</time_frame>
    <description>First hypothesis: considering a single analysis variable (age), with expected mortality of 30% in patients under 70, and 70% in patients over 70 (with 40% of patients over 70), a total of 130 patients is necessary to show a statistically significant difference between these two groups with a power of 90% (bilateral alpha risk test of 5%). Since the multivariate analysis considers the integration of several factors, considering 15 factors, hoping for a coefficient of determination of 0.5 of the model, to achieve an optimism of less than 10%, it will be necessary to include 185 patients.&#xD;
After the publication of data on mortality in ICU in Lombardy region, Italy in April 2020, it was considered that a stopping of the trial at 185 patients would impair its statistical power and induce a potential risk of patients' selection bias. As a consequence the scientific committee decided that all the patients admitted to ICU until May 7th would be proposed the study.</description>
  </primary_outcome>
  <enrollment type="Anticipated">185</enrollment>
  <condition>COVID-19 Disease, Severe Form</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group1</intervention_name>
    <description>Comorbidities (CIRS-G scale),&#xD;
Functional status of the patient with&#xD;
Clinical frailty scale (1 month before infection)&#xD;
ADL score (1 month before infection)&#xD;
Biological data&#xD;
Blood group&#xD;
TP, D-dimers, CRP, creatinine level at the patient's entry, triglyceridemia, fibrinogen, ferritin&#xD;
Parameters derived from the platelet formula count on D1 of the start of intensive care (lymphocytes, neutrophils, platelets, average platelet volume, red blood cell distribution index), SYSMEX data (IG: Immature granulocytes; HFLC: high fluorescent lymphocyte count)&#xD;
Resuscitation outcomes&#xD;
LDH rate at the start of intensive care&#xD;
PaO2 / FiO2 ratio at the start of intensive care&#xD;
IGSII / SASPII score (simplified acute physiology score) on D1 of the start of intensive care&#xD;
SOFA score (sepsis-related organ failure assessment): a posteriori estimate based on IGSII / SASPII&#xD;
Delay between the appearance of the first signs of infection and admission to intensive care</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient over 60 in intensive care unit for severe COVID infection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient over 60&#xD;
&#xD;
          -  sent to the intensive care unit&#xD;
&#xD;
          -  whose COVID diagnosis has been established (RT-PCR and / or chest scanner)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of the patient or his support person to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claire Falandry, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospices Civils de Lyon</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Claire Falandry, MD</last_name>
    <phone>33 4 78 86 32 87</phone>
    <email>claire.falandry@chu-lyon.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Resuscitation unit at Hospital Emile Roux</name>
      <address>
        <city>Le Puy-en-Velay</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claire Falandry, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>- Resuscitation unit of the Groupement Hospitalier Nord - Hospices Civils de Lyon</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claire Falandry, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>- Resuscitation unit of the Groupement Hospitalier Sud - Hospices Civils de Lyon</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claire Falandry, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Resuscitation unit of the Groupement Hospitalier Centre - Hospices Civils de Lyon</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claire Falandry, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Resuscitation unit of the Groupement Hospitalier Sud - Hospices Civils de Lyon</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claire Falandry, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Service de Réanimation de l'Hôpital Nord Ouest</name>
      <address>
        <city>Villefranche-sur-Saône</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Max Haine, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Medipole Resuscitation unit</name>
      <address>
        <city>Villeurbanne</city>
        <zip>69603</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vincent COLLANGE, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04422340
org study id: 69HCL20_0386
nct id: NCT04422340
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
With the spread of COVID-19 epidemic since 2019 in Wuhan, China health plans have to be
      adapted continuously in response to the emergency. The first publications from the Chinese
      experience demonstrate an increase in the incidence of COVID-19 infections in patients over
      60 years of age, a higher frequency of severe forms of the disease and therefore theoretical
      indications of orientation towards resuscitative care.

      However, the first published data from Hubei province suggest a low benefit of resuscitation
      for patients between 70 and 80 years of age and null in patients over 80 years of age. These
      data question the individual benefit / risk balance of an orientation towards resuscitation
      for this category of patients, their quality of life and the concept of unreasonable
      obstinacy.

      Among the covariates associated with resuscitation mortality described in the data published
      to date, cardiovascular comorbidities, certain biological covariates (LDH, creatinine,
      lymphocytes, neutrophils, TP, D-dimers, etc.), the time between the first symptoms and the
      entry into resuscitation have been identified.

      The objective of this multicentric observational study is to determine the clinical and
      biological covariates predictive of mortality in the population of patients over 60 years of
      age admitted in intensive care unit, in particular by integrating functional and nutritional
      data from patients 1 month before COVID-19 infection.
observational model: Cohort
time perspective: Other
measure: Evaluation of the impact of age on mortality at 30 days after admission to intensive care
time frame: 30 days after resuscitation admission
description: First hypothesis: considering a single analysis variable (age), with expected mortality of 30% in patients under 70, and 70% in patients over 70 (with 40% of patients over 70), a total of 130 patients is necessary to show a statistically significant difference between these two groups with a power of 90% (bilateral alpha risk test of 5%). Since the multivariate analysis considers the integration of several factors, considering 15 factors, hoping for a coefficient of determination of 0.5 of the model, to achieve an optimism of less than 10%, it will be necessary to include 185 patients.
After the publication of data on mortality in ICU in Lombardy region, Italy in April 2020, it was considered that a stopping of the trial at 185 patients would impair its statistical power and induce a potential risk of patients' selection bias. As a consequence the scientific committee decided that all the patients admitted to ICU until May 7th would be proposed the study.
intervention type: Other
intervention name: Group1
description: Comorbidities (CIRS-G scale),
Functional status of the patient with
Clinical frailty scale (1 month before infection)
ADL score (1 month before infection)
Biological data
Blood group
TP, D-dimers, CRP, creatinine level at the patient's entry, triglyceridemia, fibrinogen, ferritin
Parameters derived from the platelet formula count on D1 of the start of intensive care (lymphocytes, neutrophils, platelets, average platelet volume, red blood cell distribution index), SYSMEX data (IG: Immature granulocytes; HFLC: high fluorescent lymphocyte count)
Resuscitation outcomes
LDH rate at the start of intensive care
PaO2 / FiO2 ratio at the start of intensive care
IGSII / SASPII score (simplified acute physiology score) on D1 of the start of intensive care
SOFA score (sepsis-related organ failure assessment): a posteriori estimate based on IGSII / SASPII
Delay between the appearance of the first signs of infection and admission to intensive care
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Claire Falandry, MD
role: Principal Investigator
affiliation: Hospices Civils de Lyon
last name: Claire Falandry, MD
phone: 33 4 78 86 32 87
email: claire.falandry@chu-lyon.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor