Acute Encephalopathy in Critically Ill Patients With COVID-19

NCT04320472 | Unknown

• 1 other identifier: Neuro-COVID-19
• Study Type: observational
• Target: 250
• Locations: 7 countries
• Sites: 39

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.

Conditions

COVID-19; Encephalopathy; Critically Ill

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Favorable outcome

  3 months

• Favorable outcome

  3 months

Study Arms (1)

Follow up

Follow up of all included patients up to 3 months after enrollement

Other: Follow up

Interventions

Follow up OTHER

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

Follow up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acute encephalopathy and ICU admission

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ictal Group: lead

Study Sites (39)

Jackson Memorial Health System; University of Miami, Miller School of Medicine

Miami, Florida, 33136, United States

Location

Wellstar Atlanta Medical Center

Atlanta, Georgia, 30312, United States

Location

Universidade Federal de São Paulo

São Paulo, Brazil

Location

Fundación Valle del Lili, University Hospital

Cali, Colombia

Location

Cairo University Hospitals

Cairo, Egypt

Location

Centre Hospitalier d'Argenteuil

Argenteuil, France

Location

Centre Hospitalier de Beauvais

Beauvais, France

Location

Centre Hospitalier Universitaire Ambroise Paré

Boulogne, France

Location

Centre Hospitalier de Bourg en Bresse

Bourg-en-Bresse, France

Location

Centre Hospitalier Régional Universitaire de Brest

Brest, France

Location

Centre Hospitalier de Brives

Brive-la-Gaillarde, France

Location

Centre Hospitalier Universitaire Beaujon

Clichy, France

Location

Centre Hospitalier Universitaire Louis Mourier

Colombes, France

Location

Centre Hospitalier Universitaire Henri Mondor

Créteil, France

Location

Centre hospitalier de Dieppe

Dieppe, France

Location

Centre Hospitalier Universitaire de Dijon

Dijon, France

Location

Centre Hospitalier d'Etampes

Étampes, France

Location

Grand Hôpital de l'Est Francilien - Site de Marne-la-Vallée

Jossigny, France

Location

Centre Hospitalier de la Roche-sur-Yon

La Roche-sur-Yon, France

Location

Centre Hospitalier de La Rochelle

La Rochelle, France

Location

Centre Hospitalier de Versailles

Le Chesnay, 78150, France

Location

Centre Hospitalier Universitaire de Lille

Lille, France

Location

Centre Hospitalier Universitaire Hôpital Edouard Herriot

Lyon, France

Location

Hôpital privé Jacques Cartier

Massy, France

Location

Groupe Hospitalier Sud Ile-de-France

Melun, France

Location

Centre Hospitalier Régional d'Orléans

Orléans, France

Location

Centre Hospitalier Universitaire Cochin

Paris, France

Location

Groupe hospitalier Paris Saint-Joseph

Paris, France

Location

Hôpital Fondation Adolphe de Rothschild

Paris, France

Location

Hopital Privé Claude Galien

Quincy-sous-Sénart, France

Location

Centre Hospitalier Universitaire de Rennes

Rennes, France

Location

Centre Hospitalier de Roanne

Roanne, France

Location

Hopital Foch

Suresnes, France

Location

Centre Hospitalier de Toulon

Toulon, France

Location

Centre Hospitalier Universitaire de Toulouse

Toulouse, France

Location

Centre Hospitalier Universitaire de Tours

Tours, France

Location

Gustave-Roussy

Villejuif, France

Location

Hospital Regional De Alta Especialidad Del Bajío

Guanajuato City, Mexico

Location

Hospital Clinic Universitari

Valencia, Spain

Location

Related Publications (1)

• Legriel S, Badenes R, Engrand N, Mendoza-Trujillo R, Soulier P, Benghanem S, Pizzi M, Maciel C, Chelly J, Zuber B, Labruyere M, Plantefeve G, Jacq G, Galbois A, Launey Y, Argaud L, Lesieur O, Ferre A, Paul M, Guillon A, Bailly P, Beuret P, de-Carne MC, Siami S, Benzekri D, Colin G, Gaviria L, Aldana JL, Bruel C, Stoclin A, Sedillot N, Geri G, Samano D, Sobczak E, Swafford E, O'Phelan K, Meffert A, Holleville M, Silva S, Alves da Costa MJ, Mejia J, Alkhachroum A; for NeuroCovid19. Outcomes in Patients With COVID-19 With Acute Encephalopathy and Coma: An International Prospective Study. Neurology. 2023 May 30;100(22):e2247-e2258. doi: 10.1212/WNL.0000000000207263. Epub 2023 Apr 11.

  PMID: 37041081 DERIVED

MeSH Terms

Conditions

COVID-19; Brain Diseases; Critical Illness

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephane LEGRIEL, MD, PhD

  Ictal Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2020
• First Posted: March 25, 2020
• Study Start: March 23, 2020
• Primary Completion: September 30, 2020
• Study Completion: December 31, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

ME (1); ES (1); US (2); BR (1); FR (32); EG (1); CO (1)