Acute Encephalopathy in Critically Ill Patients With COVID-19

COVID-19 Clinical Trial

— NeuroCOVID19  

Official title:

Outcomes in Patients With Acute Encephalopathy and SARS-Cov-2 Infection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04320472
• Other study ID #: Neuro-COVID-19
• Status: Active, not recruiting
• Start date: March 23, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2020
• Source: Ictal Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: December 31, 2020
• Est. primary completion date: September 30, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• COVID-19
• Critical Illness
• Critically Ill
• Encephalopathy

Intervention

Other:
• Follow up
Follow up up to day 90 (Glasgow outcome scale, Glasgow outcome scale extended, functionnal impairments : Barthel index, Disability Rating Scale)

Locations

Country	Name	City	State
Brazil	Universidade Federal de São Paulo	São Paulo
Colombia	Fundación Valle del Lili, University Hospital	Cali
Egypt	Cairo University Hospitals	Cairo
France	Centre Hospitalier d'Argenteuil	Argenteuil
France	Centre Hospitalier de Beauvais	Beauvais
France	Centre Hospitalier Universitaire Ambroise Paré	Boulogne
France	Centre Hospitalier de Bourg en Bresse	Bourg-en-Bresse
France	Centre Hospitalier Régional Universitaire de Brest	Brest
France	Centre Hospitalier de Brives	Brive-la-Gaillarde
France	Centre Hospitalier Universitaire Beaujon	Clichy
France	Centre Hospitalier Universitaire Louis Mourier	Colombes
France	Centre Hospitalier Universitaire Henri Mondor	Créteil
France	Centre hospitalier de Dieppe	Dieppe
France	Centre Hospitalier Universitaire de Dijon	Dijon
France	Centre Hospitalier d'Etampes	Etampes
France	Grand Hôpital de l'Est Francilien - Site de Marne-la-Vallée	Jossigny
France	Centre Hospitalier de la Roche-sur-Yon	La Roche-sur-Yon
France	Centre Hospitalier de La Rochelle	La Rochelle
France	Centre Hospitalier de Versailles	Le Chesnay
France	Centre Hospitalier Universitaire de Lille	Lille
France	Centre Hospitalier Universitaire Hôpital Edouard Herriot	Lyon
France	Hôpital privé Jacques Cartier	Massy
France	Groupe Hospitalier Sud Ile-de-France	Melun
France	Centre Hospitalier Régional d'Orléans	Orléans
France	Centre Hospitalier Universitaire Cochin	Paris
France	Groupe hospitalier Paris Saint-Joseph	Paris
France	Hôpital Fondation Adolphe de Rothschild	Paris
France	Hopital Privé Claude Galien	Quincy-sous-Sénart
France	Centre Hospitalier Universitaire de Rennes	Rennes
France	Centre Hospitalier de Roanne	Roanne
France	Hopital Foch	Suresnes
France	Centre Hospitalier de Toulon	Toulon
France	Centre Hospitalier Universitaire de Toulouse	Toulouse
France	Centre Hospitalier Universitaire de Tours	Tours
France	Gustave-Roussy	Villejuif
Mexico	Hospital Regional De Alta Especialidad Del Bajío	Guanajuato
Spain	Hospital Clinic Universitari	Valencia
United States	Wellstar Atlanta Medical Center	Atlanta	Georgia
United States	Jackson Memorial Health System; University of Miami, Miller School of Medicine	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Ictal Group

Countries where clinical trial is conducted

United States,  Brazil,  Colombia,  Egypt,  France,  Mexico,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence	ratio of patients with acute encephalopathy among the total of patients with SARS-Cov-2 infection at Critical/Intensive care or Neurocritical care admission	at Critical/Intensive care or Neurocritical care admission
Secondary	Favorable outcome	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]	3 months
Secondary	Favorable outcome	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]	3 months