<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/NCT04468035</url>
  </required_header>
  <id_info>
    <org_study_id>CognitiVID</org_study_id>
    <nct_id>NCT04468035</nct_id>
  </id_info>
  <brief_title>Early Cognitive Assessment and Evolutionary Monitoring of Patients With Severe ARDS on COVID-19 Pneumonia Requiring Mechanical Ventilation</brief_title>
  <acronym>CognitiVID</acronym>
  <official_title>Early Cognitive Assessment and Evolutionary Monitoring of Patients With Severe ARDS (Acute Respiratory Distress Syndrome) on SARS-CoV2 Viral Pneumonia Requiring Mechanical Ventilation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Hôpital Saint-Joseph</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Hôpital Saint-Joseph</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 new coronavirus pandemic responsible for the severe acute respiratory syndrome SARS-CoV2&#xD;
      requires, in its severe forms, the use of invasive ventilation in intensive care.&#xD;
&#xD;
      The first patients seen in intensive care presented with neurological symptoms and usually&#xD;
      not seen in non-viral ARDS or due to other viral causes. These were mainly restless&#xD;
      awakenings, attempts at self-extubation and confusional syndromes. Although the data in the&#xD;
      literature do not seem to reveal the presence of SARS-CoV2 in the CSF of these patients,&#xD;
      certain elements seem to show parenchymal brain damage with the description of hypometabolism&#xD;
      of the frontal regions. In addition, most of these patients present a memory complaint after&#xD;
      going into intensive care (personal data not published).&#xD;
&#xD;
      We do not know to date what is the cognitive and psychic profile of these patients, nor what&#xD;
      will be their future evolution. Some patients may require specific neuro-cognitive&#xD;
      rehabilitation.&#xD;
&#xD;
      The aim of this study is to assess the cognitive profile of patients infected with COVID-19&#xD;
      who have used invasive ventilation in the intensive care unit of Paris Saint-Joseph hospital&#xD;
      since April 2020, in order to be able to compare them between them and follow their evolution&#xD;
      in the medium term. This work could make it possible to describe the specific cognitive&#xD;
      impairment of SARS-CoV2, by trying to evade other causes of cognitive disorders in patients&#xD;
      hospitalized in intensive care for respiratory distress (hypoxia, treatments, metabolic&#xD;
      disorders, etc.).&#xD;
&#xD;
      The main objective is to follow the medium-term evolution between 3 and 6 months of the&#xD;
      cognitive profile of patients with severe form of SARS-CoV2 with the use of ventilatory&#xD;
      resuscitation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">May 23, 2022</completion_date>
  <primary_completion_date type="Actual">December 31, 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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Medium-term evolution between 3 and 6 months</measure>
    <time_frame>Month 6</time_frame>
    <description>This ouctome corresponds to the medium-term evolution between 3 and 6 months of the cognitive profile of patients with severe form of SARS-CoV2 with recourse to ventilatory resuscitation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cognitive impairment at M3</measure>
    <time_frame>Month 3</time_frame>
    <description>This outcome corresponds to MMSE orientation score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive impairment at M6</measure>
    <time_frame>Month 6</time_frame>
    <description>This outcome corresponds to MMSE orientation score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Memory Scores at M3</measure>
    <time_frame>Month 3</time_frame>
    <description>This outcome corresponds to Memory scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Memory Scores at M6</measure>
    <time_frame>Month 6</time_frame>
    <description>This outcome corresponds to Memory scores.</description>
  </secondary_outcome>
  <enrollment type="Actual">22</enrollment>
  <condition>Covid19</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients hospitalized in the intensive care unit of the Paris Saint-Joseph Hospital (HPSJ),&#xD;
        for the management of their respiratory distress following COVID infection, between April&#xD;
        2020 and April 2021.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient whose age ≥ 18 years&#xD;
&#xD;
          -  Patient with SARS-CoV2 treated in the intensive care unit of the HPSJ for respiratory&#xD;
             distress, using invasive ventilation by oro-tracheal intubation from April 2020&#xD;
&#xD;
          -  French speaking patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with an alertness disorder with Glasgow eye score &lt;3 and / or motor &lt;6&#xD;
             (confusion being a poor criterion for evaluating the Glasgow score apart from head&#xD;
             trauma).&#xD;
&#xD;
          -  Patient with impossibility to communicate (mutism, aphonia, major language barrier)&#xD;
&#xD;
          -  Patient under guardianship or curatorship&#xD;
&#xD;
          -  Patient deprived of liberty&#xD;
&#xD;
          -  Patient objecting to the use of his data for this research&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clement Vialatte de Pémille, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondation Hôpital Saint-Joseph</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Groupe Hospitalier Paris Saint-Joseph</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Alkeridy WA, Almaghlouth I, Alrashed R, Alayed K, Binkhamis K, Alsharidi A, Liu-Ambrose T. A Unique Presentation of Delirium in a Patient with Otherwise Asymptomatic COVID-19. J Am Geriatr Soc. 2020 Jul;68(7):1382-1384. doi: 10.1111/jgs.16536. Epub 2020 May 16.</citation>
    <PMID>32383778</PMID>
  </reference>
  <reference>
    <citation>Helms J, Kremer S, Merdji H, Clere-Jehl R, Schenck M, Kummerlen C, Collange O, Boulay C, Fafi-Kremer S, Ohana M, Anheim M, Meziani F. Neurologic Features in Severe SARS-CoV-2 Infection. N Engl J Med. 2020 Jun 4;382(23):2268-2270. doi: 10.1056/NEJMc2008597. Epub 2020 Apr 15. No abstract available.</citation>
    <PMID>32294339</PMID>
  </reference>
  <reference>
    <citation>Bouattour N, Farhat N, Hadjkacem H, Hdiji O, Sakka S, Dammak M, Mhiri C. [Five-word test calibration in a Tunisian population of healthy subjects]. Pan Afr Med J. 2019 Sep 30;34:58. doi: 10.11604/pamj.2019.34.58.14472. eCollection 2019. French.</citation>
    <PMID>31762923</PMID>
  </reference>
  <reference>
    <citation>Maillet D, Matharan F, Le Clesiau H, Bailon O, Peres K, Amieva H, Belin C. TNI-93: A New Memory Test for Dementia Detection in Illiterate and Low-Educated Patients. Arch Clin Neuropsychol. 2016 Dec 1;31(8):896-903. doi: 10.1093/arclin/acw065.</citation>
    <PMID>27590305</PMID>
  </reference>
  <results_reference>
    <citation>Vialatte de Pemille C, Ray A, Michel A, Stefano F, Yim T, Bruel C, Zuber M. Prevalence and prospective evaluation of cognitive dysfunctions after SARS due to SARS-CoV-2 virus. The COgnitiVID study. Rev Neurol (Paris). 2022 Oct;178(8):802-807. doi: 10.1016/j.neurol.2022.03.014. Epub 2022 May 13.</citation>
    <PMID>35610098</PMID>
  </results_reference>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>September 30, 2022</last_update_submitted>
  <last_update_submitted_qc>September 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <!-- 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/NCT04468035
org study id: CognitiVID
nct id: NCT04468035
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The new coronavirus pandemic responsible for the severe acute respiratory syndrome SARS-CoV2
      requires, in its severe forms, the use of invasive ventilation in intensive care.

      The first patients seen in intensive care presented with neurological symptoms and usually
      not seen in non-viral ARDS or due to other viral causes. These were mainly restless
      awakenings, attempts at self-extubation and confusional syndromes. Although the data in the
      literature do not seem to reveal the presence of SARS-CoV2 in the CSF of these patients,
      certain elements seem to show parenchymal brain damage with the description of hypometabolism
      of the frontal regions. In addition, most of these patients present a memory complaint after
      going into intensive care (personal data not published).

      We do not know to date what is the cognitive and psychic profile of these patients, nor what
      will be their future evolution. Some patients may require specific neuro-cognitive
      rehabilitation.

      The aim of this study is to assess the cognitive profile of patients infected with COVID-19
      who have used invasive ventilation in the intensive care unit of Paris Saint-Joseph hospital
      since April 2020, in order to be able to compare them between them and follow their evolution
      in the medium term. This work could make it possible to describe the specific cognitive
      impairment of SARS-CoV2, by trying to evade other causes of cognitive disorders in patients
      hospitalized in intensive care for respiratory distress (hypoxia, treatments, metabolic
      disorders, etc.).

      The main objective is to follow the medium-term evolution between 3 and 6 months of the
      cognitive profile of patients with severe form of SARS-CoV2 with the use of ventilatory
      resuscitation.
observational model: Cohort
time perspective: Cross-Sectional
measure: Medium-term evolution between 3 and 6 months
time frame: Month 6
description: This ouctome corresponds to the medium-term evolution between 3 and 6 months of the cognitive profile of patients with severe form of SARS-CoV2 with recourse to ventilatory resuscitation.
measure: Cognitive impairment at M3
time frame: Month 3
description: This outcome corresponds to MMSE orientation score.
measure: Cognitive impairment at M6
time frame: Month 6
description: This outcome corresponds to MMSE orientation score.
measure: Memory Scores at M3
time frame: Month 3
description: This outcome corresponds to Memory scores.
measure: Memory Scores at M6
time frame: Month 6
description: This outcome corresponds to Memory scores.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clement Vialatte de Pémille, MD
role: Principal Investigator
affiliation: Fondation Hôpital Saint-Joseph
facility: 
country: France
citation: Alkeridy WA, Almaghlouth I, Alrashed R, Alayed K, Binkhamis K, Alsharidi A, Liu-Ambrose T. A Unique Presentation of Delirium in a Patient with Otherwise Asymptomatic COVID-19. J Am Geriatr Soc. 2020 Jul;68(7):1382-1384. doi: 10.1111/jgs.16536. Epub 2020 May 16.
PMID: 32383778
citation: Helms J, Kremer S, Merdji H, Clere-Jehl R, Schenck M, Kummerlen C, Collange O, Boulay C, Fafi-Kremer S, Ohana M, Anheim M, Meziani F. Neurologic Features in Severe SARS-CoV-2 Infection. N Engl J Med. 2020 Jun 4;382(23):2268-2270. doi: 10.1056/NEJMc2008597. Epub 2020 Apr 15. No abstract available.
PMID: 32294339
citation: Bouattour N, Farhat N, Hadjkacem H, Hdiji O, Sakka S, Dammak M, Mhiri C. [Five-word test calibration in a Tunisian population of healthy subjects]. Pan Afr Med J. 2019 Sep 30;34:58. doi: 10.11604/pamj.2019.34.58.14472. eCollection 2019. French.
PMID: 31762923
citation: Maillet D, Matharan F, Le Clesiau H, Bailon O, Peres K, Amieva H, Belin C. TNI-93: A New Memory Test for Dementia Detection in Illiterate and Low-Educated Patients. Arch Clin Neuropsychol. 2016 Dec 1;31(8):896-903. doi: 10.1093/arclin/acw065.
PMID: 27590305
citation: Vialatte de Pemille C, Ray A, Michel A, Stefano F, Yim T, Bruel C, Zuber M. Prevalence and prospective evaluation of cognitive dysfunctions after SARS due to SARS-CoV-2 virus. The COgnitiVID study. Rev Neurol (Paris). 2022 Oct;178(8):802-807. doi: 10.1016/j.neurol.2022.03.014. Epub 2022 May 13.
PMID: 35610098
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Pneumonia