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Acute Encephalopathy in Critically Ill Patients With COVID-19 (NeuroCOVID19)

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ClinicalTrials.gov Identifier: NCT04320472
Recruitment Status : Recruiting
First Posted : March 25, 2020
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Ictal Group

Brief Summary:

Infection with SARS-CoV-2 or severe acute respiratory syndrome coronarvirus type 2 was highlighted in December 2019 in the city of Wuhan in China, responsible for an pandemic evolution since March 11, 2020. The infection affects all ages of life, although affecting children in a very small proportion of cases. The typical presentation of the disease combines fever (98%), cough (76%), myalgia and asthenia (18%) as well as leukopenia (25%) and lymphopenia (63%). Upper airway involvement rare.

The main clinical presentation requiring hospitalization of infected patients is that of atypical pneumonia which may require critical care management (27%), and progress to an acute respiratory distress syndrome (67%) involving life-threatening conditions in almost 25% of patients diagnosed with SARS-CoV-2 infection. Other organ damage have been reported, mainly concerning kidney damage (29%) which may require renal replacement therapy in approximately 17% of patients.

Neurological damage has been very rarely studied, yet reported in 36% of cases in a study including patients of varying severity.

Finally, the mortality associated with this emerging virus is high in patients for whom critical care management is necessary, reported in 62% of patients.

We therefore propose a prospective observational study which aim at reporting the prevalence of acute encephalopathy at initial management in Critical/Intensive care or Neurocritical care , to report its morbidity and mortality and to identify prognostic factors.


Condition or disease Intervention/treatment
COVID-19 Encephalopathy Critically Ill Other: Follow up

Detailed Description:

All patients with SARS-CoV-2 infection and acute encephalopathy at presentation will be prospectively included in the NEURO-COVD-19 study. This study will collect demographic data, clinical examen at prehospital/emergency room and ICU admission (including neurological signs), and all ancillary exams performed to identify a cause of neurological impairment. Outcome will be evaluated using the Glasgow Outcome Scale score at ICU and hospital discharge, and day-90 after ICU admission.

Acute encephalopathy will be defined as recently stated :

"1. The term acute encephalopathy refers to a rapidly developing (over less than 4 weeks, but usually within hours to a few days) pathobiological process in the brain. This is a preferred term 2. Acute encephalopathy can lead to a clinical presentation of subsyndromal delirium, delirium, or in case of a severely decreased level of consciousness, coma; all representing a change from baseline cognitive status 3. The term delirium refers to a clinical state characterized by a combination of features defined by diagnostic systems such as the DSM-5. Delirium according to the DSM-5 is defined if criterium A-E are fulfilled: A. Disturbance in attention (i.e., reduced ability to direct, focus, sustain, and shift attention) and awareness (reduced orientation to the environment). B. The disturbance develops over a short period of time (usually hours to a few days) represents a change from baseline attention and awareness, and tends to fluctuate in severity during the course of the day. C. An additional disturbance in cognition (e.g., memory deficit, disorientation, language, visuospatial ability, or perception). D. The disturbances in criteria A and C are not explained by another pre-existing, established, or evolving neurocognitive disorder, and do not occur in the context of a severely reduced level of arousal, such as coma. E. There is evidence from the history, physical examination, or laboratory findings that the disturbance is a direct physiologic consequence of another medical condition, substance intoxication or withdrawal (i.e. because of a drug of abuse medication), or exposure to a toxin, or is because of multiple etiologies. " (Slooter, A.J.C., Otte, W.M., Devlin, J.W. et al. Updated nomenclature of delirium and acute encephalopathy: statement of ten Societies. Intensive Care Med (2020). https://doi.org/10.1007/s00134-019-05907-4)

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Outcomes in Patients With Acute Encephalopathy and SARS-Cov-2 Infection
Actual Study Start Date : March 23, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Group/Cohort Intervention/treatment
Follow up
Follow up of all included patients up to 3 months after enrollement
Other: Follow up
Follow up up to day 90 (Glasgow outcome scale, Glasgow outcome scale extended, functionnal impairments : Barthel index, Disability Rating Scale)




Primary Outcome Measures :
  1. prevalence [ Time Frame: at Critical/Intensive care or Neurocritical care admission ]
    ratio of patients with acute encephalopathy among the total of patients with SARS-Cov-2 infection at Critical/Intensive care or Neurocritical care admission


Secondary Outcome Measures :
  1. Favorable outcome [ Time Frame: 3 months ]
    A favorable outcome is defined by a Glasgow Outcome Scale (GOS) of 5. The Glasgow Outcome Scale (GOS) will be determined patients charts review, phone call, and/or general practitioner interview conducted by an independent assessor. The GOS score : [1: Death, 2: Persistent vegetative state, 3: Severe disability, 4: Moderate disability, 5 : Low disability]

  2. Favorable outcome [ Time Frame: 3 months ]
    A favorable outcome is defined by a Glasgow Outcome Scale Extended (GOSe) >= 5. The Glasgow Outcome Scale Extended (GOSe) will be determined patients charts review, phone call, and/or general practitioner interview conducted by an independent assessor. The GOSe score : [1: Death, 2: Persistent vegetative state, 3: Severe disability Lower, 4: Severe disability Upper, 5: Moderate disability Lower, 6: Moderate disability Upper, 7 : Good recovery lower, 8 : Good recovery Upper]



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Acute encephalopathy and ICU admission
Criteria

Inclusion Criteria:

  • Critical/Intensive care or Neurocritical care admission
  • Admission for/with acute encephalopathy defined as a rapidly developing (over less than 4 weeks, but usually within hours to a few days) pathobiological process in the brain; including delirium or subsyndromal (DSM V definition) or coma (Glasgow coma scale score < 9)
  • SARS-COV-2 infection (respiratory or other PCR specimen)
  • Age ≥ 18 years

Exclusion Criteria:

- Opposition to study participation from the patient itself or patient surrogate


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): NCT04320472


Contacts
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Contact: Stephane LEGRIEL, MD, PhD 33139638839 neurocovid19study@ictalgroup.org

Locations
Show Show 38 study locations
Sponsors and Collaborators
Ictal Group
Investigators
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Principal Investigator: Stephane LEGRIEL, MD, PhD Ictal Group
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Responsible Party: Ictal Group
ClinicalTrials.gov Identifier: NCT04320472    
Other Study ID Numbers: Neuro-COVID-19
First Posted: March 25, 2020    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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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Brain Diseases
Critical Illness
Disease Attributes
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases