<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/NCT04499300</url>
  </required_header>
  <id_info>
    <org_study_id>CHUB-COVID-19-90+</org_study_id>
    <nct_id>NCT04499300</nct_id>
  </id_info>
  <brief_title>Elderly Patients and COVID-19 Infection: a Cohort of Fifty Patients Over Ninety Years of Age</brief_title>
  <official_title>Elderly Patients and COVID-19 Infection: a Cohort of Fifty Patients Over Ninety Years of Age</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Murielle Surquin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brugmann University Hospital</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>
      SARS-CoV2 or CoVid19 disease is a newly described pathology linked to a subtype of the&#xD;
      coronavirus family identified in China in December 2019. This pathology can present multiple&#xD;
      clinical facets, ranging from asymptomatic forms to more commonly critical pulmonary forms&#xD;
      called &quot;Acute Respiratory Distress Syndrome&quot;. The elderly population is more at risk for this&#xD;
      infection due to the senescence of the immune system, co-morbidities and poly medications.&#xD;
      They also often present a greater state of fragility.&#xD;
&#xD;
      This study aims to report the epidemiology of the first 50 patients over 90 years of age&#xD;
      hospitalized within the CHU Brugmann hospital.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 9, 2020</start_date>
  <completion_date type="Actual">November 23, 2020</completion_date>
  <primary_completion_date type="Actual">November 23, 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>Demographic data</measure>
    <time_frame>5 minutes</time_frame>
    <description>Age, sex, ethnicity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comorbidities</measure>
    <time_frame>5 minutes</time_frame>
    <description>Smoking, Obesity, Diabetes, Arterial hypertension, Coronary pathology, Cerebrovascular disease, chronic renal failure, chronic obstructive pulmonary disease, Neoplasia, Autoimmune disease, Chronic liver disease</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cumulative Illness Rating Scale-Geriatric (CIRS-G)</measure>
    <time_frame>5 minutes</time_frame>
    <description>CIRS-G quantifies burden of disease in elderly patients (comorbidity scale). Higher scores indicate higher severity (maximum score = 56 points).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatments</measure>
    <time_frame>5 minutes</time_frame>
    <description>Under Chronic corticosteroid therapy or Immunosuppressive therapy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Signs and symptoms</measure>
    <time_frame>5 minutes</time_frame>
    <description>Presence and date of first apparition: Fever, Cough, Dyspnea, Chest pain, Nausea or vomiting, Diarrhea, Fatigue, Anosmia, ageusia, inappetence, Confusion, Fall, Fracture</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fever</measure>
    <time_frame>5 minutes</time_frame>
    <description>Vital signs at hospital admission: Fever</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hypoxemia</measure>
    <time_frame>5 minutes</time_frame>
    <description>Vital signs at hospital admission: Hypoxemia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tachycardia</measure>
    <time_frame>5 minutes</time_frame>
    <description>Vital signs at hospital admission:Tachycardia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hypotension</measure>
    <time_frame>5 minutes</time_frame>
    <description>Vital signs at hospital admission: Hypotension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gasometry</measure>
    <time_frame>5 minutes</time_frame>
    <description>Vital signs at hospital admission: Gasometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infectious data</measure>
    <time_frame>5 minutes</time_frame>
    <description>Contact with confirmed covid person before admission, lives in a retirement home with other cases, Initial bacterial or viral co-infection, Bacterial or viral co-infection during the hospital stay</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood count</measure>
    <time_frame>5 minutes</time_frame>
    <description>Blood count at hospital admission or first recorded</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ionogram</measure>
    <time_frame>5 minutes</time_frame>
    <description>Ionogram at hospital admission or first recorded</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Liver function</measure>
    <time_frame>5 minutes</time_frame>
    <description>Liver function at hospital admission or first recorded</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Coagulation</measure>
    <time_frame>5 minutes</time_frame>
    <description>Coagulation at hospital admission or first recorded</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Renal function</measure>
    <time_frame>5 minutes</time_frame>
    <description>Renal function at hospital admission or first recorded</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Albumin</measure>
    <time_frame>5 minutes</time_frame>
    <description>Albumin at hospital admission or first recorded</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CRP</measure>
    <time_frame>5 minutes</time_frame>
    <description>CRP at hospital admission or first recorded</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fibrinogen</measure>
    <time_frame>5 minutes</time_frame>
    <description>Fibrinogen at hospital admission or first recorded</description>
  </primary_outcome>
  <primary_outcome>
    <measure>D-dimers at hospital admission or first recorded</measure>
    <time_frame>5 minutes</time_frame>
    <description>D-dimers</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NTproBNP</measure>
    <time_frame>5 minutes</time_frame>
    <description>NTproBNP at hospital admission or first recorded</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CK</measure>
    <time_frame>5 minutes</time_frame>
    <description>CK at hospital admission or first recorded</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Troponin</measure>
    <time_frame>5 minutes</time_frame>
    <description>Troponin at hospital admission or first recorded</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ferritin</measure>
    <time_frame>5 minutes</time_frame>
    <description>Ferritin at hospital admission or first recorded</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Procalcitonin</measure>
    <time_frame>5 minutes</time_frame>
    <description>Procalcitonin at hospital admission or first recorded</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biology - highest rate</measure>
    <time_frame>5 minutes</time_frame>
    <description>Highest rate of CRP, D-Dimers, Urea, Creatinin, Fibrinogen, CK, Troponins</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biology - lowest rate</measure>
    <time_frame>5 minutes</time_frame>
    <description>Lowest rate of hemoglobin, platelets, leucocytes, lymphocytes, albumin, Na+, K+</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of pulmonary involvement on chest CT scan</measure>
    <time_frame>5 minutes</time_frame>
    <description>Percentage of pulmonary involvement on chest CT scan</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of pulmonary lobes affected</measure>
    <time_frame>5 minutes</time_frame>
    <description>Number of pulmonary lobes affected</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Type of lesions</measure>
    <time_frame>5 minutes</time_frame>
    <description>Type of lesions as reflected on the CT scan images: 'Ground glass' or 'Crazy paving'</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Need for oxygenotherapy</measure>
    <time_frame>5 minutes</time_frame>
    <description>Need for oxygenotherapy (yes/no)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Means of ventilation</measure>
    <time_frame>5 minutes</time_frame>
    <description>Means of ventilation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment received</measure>
    <time_frame>5 minutes</time_frame>
    <description>Hydroxychloroquine or Azithromycin</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Length of ICU Stay</measure>
    <time_frame>5 minutes</time_frame>
    <description>Length of ICU Stay</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Status at hospital exit</measure>
    <time_frame>5 minutes</time_frame>
    <description>One of the following choices: death, went back home, went back to a retirement home, was placed in a revalidation unit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>5 minutes</time_frame>
    <description>28-day mortality after PCR / CT scan / diagnosis</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>Covid positive</arm_group_label>
    <description>Patients over 90 years old hospitalized within the CHU Brugmann between 03/01/2020 and 05/10/2020 with SARS Cov2 infection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sub-group: deceased patients</arm_group_label>
    <description>Patients over 90 years old hospitalized within the CHU Brugmann between 03/01/2020 and 05/10/2020 with SARS Cov2 infection, with death as outcome.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sub-group: patients who survived</arm_group_label>
    <description>Patients over 90 years old hospitalized within the CHU Brugmann between 03/01/2020 and 05/10/2020 with SARS Cov2 infection, who survived the infection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data collection from medical files</intervention_name>
    <description>Data collection from medical files</description>
    <arm_group_label>Covid positive</arm_group_label>
    <arm_group_label>Sub-group: deceased patients</arm_group_label>
    <arm_group_label>Sub-group: patients who survived</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Same as inclusion criteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be over 90 years of age on the date of admission to CHU Brugmann Hospital&#xD;
&#xD;
          -  Have a SARS Cov2 infection proven by antigen or RT-PCR on smear and / or typical&#xD;
             imaging regardless of the clinical manifestation&#xD;
&#xD;
          -  Have been hospitalized at CHU Brugmann between 03/01/2020 and 05/10/2020&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>90 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU Brugmann</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>March 28, 2022</last_update_submitted>
  <last_update_submitted_qc>March 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Brugmann University Hospital</investigator_affiliation>
    <investigator_full_name>Murielle Surquin</investigator_full_name>
    <investigator_title>Head of geriatry department</investigator_title>
  </responsible_party>
  <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>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/NCT04499300
org study id: CHUB-COVID-19-90+
nct id: NCT04499300
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
SARS-CoV2 or CoVid19 disease is a newly described pathology linked to a subtype of the
      coronavirus family identified in China in December 2019. This pathology can present multiple
      clinical facets, ranging from asymptomatic forms to more commonly critical pulmonary forms
      called "Acute Respiratory Distress Syndrome". The elderly population is more at risk for this
      infection due to the senescence of the immune system, co-morbidities and poly medications.
      They also often present a greater state of fragility.

      This study aims to report the epidemiology of the first 50 patients over 90 years of age
      hospitalized within the CHU Brugmann hospital.
observational model: Cohort
time perspective: Retrospective
measure: Demographic data
time frame: 5 minutes
description: Age, sex, ethnicity
measure: Comorbidities
time frame: 5 minutes
description: Smoking, Obesity, Diabetes, Arterial hypertension, Coronary pathology, Cerebrovascular disease, chronic renal failure, chronic obstructive pulmonary disease, Neoplasia, Autoimmune disease, Chronic liver disease
measure: Cumulative Illness Rating Scale-Geriatric (CIRS-G)
time frame: 5 minutes
description: CIRS-G quantifies burden of disease in elderly patients (comorbidity scale). Higher scores indicate higher severity (maximum score = 56 points).
measure: Treatments
time frame: 5 minutes
description: Under Chronic corticosteroid therapy or Immunosuppressive therapy
measure: Signs and symptoms
time frame: 5 minutes
description: Presence and date of first apparition: Fever, Cough, Dyspnea, Chest pain, Nausea or vomiting, Diarrhea, Fatigue, Anosmia, ageusia, inappetence, Confusion, Fall, Fracture
measure: Fever
time frame: 5 minutes
description: Vital signs at hospital admission: Fever
measure: Hypoxemia
time frame: 5 minutes
description: Vital signs at hospital admission: Hypoxemia
measure: Tachycardia
time frame: 5 minutes
description: Vital signs at hospital admission:Tachycardia
measure: Hypotension
time frame: 5 minutes
description: Vital signs at hospital admission: Hypotension
measure: Gasometry
time frame: 5 minutes
description: Vital signs at hospital admission: Gasometry
measure: Infectious data
time frame: 5 minutes
description: Contact with confirmed covid person before admission, lives in a retirement home with other cases, Initial bacterial or viral co-infection, Bacterial or viral co-infection during the hospital stay
measure: Blood count
time frame: 5 minutes
description: Blood count at hospital admission or first recorded
measure: Ionogram
time frame: 5 minutes
description: Ionogram at hospital admission or first recorded
measure: Liver function
time frame: 5 minutes
description: Liver function at hospital admission or first recorded
measure: Coagulation
time frame: 5 minutes
description: Coagulation at hospital admission or first recorded
measure: Renal function
time frame: 5 minutes
description: Renal function at hospital admission or first recorded
measure: Albumin
time frame: 5 minutes
description: Albumin at hospital admission or first recorded
measure: CRP
time frame: 5 minutes
description: CRP at hospital admission or first recorded
measure: Fibrinogen
time frame: 5 minutes
description: Fibrinogen at hospital admission or first recorded
measure: D-dimers at hospital admission or first recorded
time frame: 5 minutes
description: D-dimers
measure: NTproBNP
time frame: 5 minutes
description: NTproBNP at hospital admission or first recorded
measure: CK
time frame: 5 minutes
description: CK at hospital admission or first recorded
measure: Troponin
time frame: 5 minutes
description: Troponin at hospital admission or first recorded
measure: Ferritin
time frame: 5 minutes
description: Ferritin at hospital admission or first recorded
measure: Procalcitonin
time frame: 5 minutes
description: Procalcitonin at hospital admission or first recorded
measure: Biology - highest rate
time frame: 5 minutes
description: Highest rate of CRP, D-Dimers, Urea, Creatinin, Fibrinogen, CK, Troponins
measure: Biology - lowest rate
time frame: 5 minutes
description: Lowest rate of hemoglobin, platelets, leucocytes, lymphocytes, albumin, Na+, K+
measure: Percentage of pulmonary involvement on chest CT scan
time frame: 5 minutes
description: Percentage of pulmonary involvement on chest CT scan
measure: Number of pulmonary lobes affected
time frame: 5 minutes
description: Number of pulmonary lobes affected
measure: Type of lesions
time frame: 5 minutes
description: Type of lesions as reflected on the CT scan images: 'Ground glass' or 'Crazy paving'
measure: Need for oxygenotherapy
time frame: 5 minutes
description: Need for oxygenotherapy (yes/no)
measure: Means of ventilation
time frame: 5 minutes
description: Means of ventilation
measure: Treatment received
time frame: 5 minutes
description: Hydroxychloroquine or Azithromycin
measure: Length of ICU Stay
time frame: 5 minutes
description: Length of ICU Stay
measure: Status at hospital exit
time frame: 5 minutes
description: One of the following choices: death, went back home, went back to a retirement home, was placed in a revalidation unit.
measure: Mortality
time frame: 5 minutes
description: 28-day mortality after PCR / CT scan / diagnosis
arm group label: Covid positive
description: Patients over 90 years old hospitalized within the CHU Brugmann between 03/01/2020 and 05/10/2020 with SARS Cov2 infection.
arm group label: Sub-group: deceased patients
description: Patients over 90 years old hospitalized within the CHU Brugmann between 03/01/2020 and 05/10/2020 with SARS Cov2 infection, with death as outcome.
arm group label: Sub-group: patients who survived
description: Patients over 90 years old hospitalized within the CHU Brugmann between 03/01/2020 and 05/10/2020 with SARS Cov2 infection, who survived the infection.
intervention type: Other
intervention name: Data collection from medical files
description: Data collection from medical files
arm group label: Covid positive
arm group label: Sub-group: deceased patients
arm group label: Sub-group: patients who survived
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 90 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Belgium
responsible party type: Sponsor-Investigator
investigator affiliation: Brugmann University Hospital
investigator full name: Murielle Surquin
investigator title: Head of geriatry department
mesh term: COVID-19
sharing ipd: No