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Early Cognitive Assessment and Evolutionary Monitoring of Patients With Severe ARDS on COVID-19 Pneumonia Requiring Mechanical Ventilation (CognitiVID)

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ClinicalTrials.gov Identifier: NCT04468035
Recruitment Status : Recruiting
First Posted : July 13, 2020
Last Update Posted : August 20, 2021
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

Brief Summary:

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.


Condition or disease
Covid19

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021





Primary Outcome Measures :
  1. Medium-term evolution between 3 and 6 months [ Time Frame: Month 6 ]
    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.


Secondary Outcome Measures :
  1. Cognitive impairment at M3 [ Time Frame: Month 3 ]
    This outcome corresponds to MMSE orientation score.

  2. Cognitive impairment at M6 [ Time Frame: Month 6 ]
    This outcome corresponds to MMSE orientation score.

  3. Memory Scores at M3 [ Time Frame: Month 3 ]
    This outcome corresponds to Memory scores.

  4. Memory Scores at M6 [ Time Frame: Month 6 ]
    This outcome corresponds to Memory scores.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients hospitalized in the intensive care unit of the Paris Saint-Joseph Hospital (HPSJ), for the management of their respiratory distress following COVID infection, between April 2020 and April 2021.
Criteria

Inclusion Criteria:

  • Patient whose age ≥ 18 years
  • Patient with SARS-CoV2 treated in the intensive care unit of the HPSJ for respiratory distress, using invasive ventilation by oro-tracheal intubation from April 2020
  • French speaking patient

Exclusion Criteria:

  • Patient with an alertness disorder with Glasgow eye score <3 and / or motor <6 (confusion being a poor criterion for evaluating the Glasgow score apart from head trauma).
  • Patient with impossibility to communicate (mutism, aphonia, major language barrier)
  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient objecting to the use of his data for this research

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04468035


Contacts
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Contact: Clément Vialatte de Pémille, MD 0144127496 ext +33 cvialatte@ghpsj.fr
Contact: Helene BEAUSSIER, PharmD, pHD 0144127883 ext +33 crc@ghpsj.fr

Locations
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France
Groupe Hospitalier Paris Saint-Joseph Recruiting
Paris, France, 75014
Contact: Clément Vialatte de Pémille, MD    0144127496 ext +33    cvialatte@ghpsj.fr   
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Investigators
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Principal Investigator: Clement Vialatte de Pémille, MD Groupe Hospitalier Paris Saint Joseph
Publications of Results:
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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT04468035    
Other Study ID Numbers: CognitiVID
First Posted: July 13, 2020    Key Record Dates
Last Update Posted: August 20, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia
Respiratory Tract Infections
Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases