COVID-19NeuroCOVID19NCT04320472
Acute Encephalopathy in Critically Ill Patients With COVID-19
An observational study of COVID-19 and Encephalopathy, run by Ictal Group at 39 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Encephalopathy, Critically Ill
- What is being tested?
- Follow up
- How many people
- 250 participants
- Where
- 39 sitesin 7 countries
- Study dates
- 23 Mar 2020to 31 Dec 2020
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Acute encephalopathy and ICU admission
Who may be able to join
- 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
Who cannot join
- Opposition to study participation from the patient itself or patient surrogate
Trial locations and contacts
39 sites in 7 countries.
39 sites in 7 countries
France32 sites
Centre Hospitalier d'Argenteuil
Argenteuil
Centre Hospitalier de Beauvais
Beauvais
Centre Hospitalier Universitaire Ambroise Paré
Boulogne
Centre Hospitalier de Bourg en Bresse
Bourg-en-Bresse
Centre Hospitalier Régional Universitaire de Brest
Brest
Centre Hospitalier de Brives
Brive-la-Gaillarde
Centre Hospitalier Universitaire Beaujon
Clichy
Centre Hospitalier Universitaire Louis Mourier
Colombes
Centre Hospitalier Universitaire Henri Mondor
Créteil
Centre hospitalier de Dieppe
Dieppe
Centre Hospitalier Universitaire de Dijon
Dijon
Centre Hospitalier d'Etampes
Étampes
Grand Hôpital de l'Est Francilien - Site de Marne-la-Vallée
Jossigny
Centre Hospitalier de la Roche-sur-Yon
La Roche-sur-Yon
Centre Hospitalier de La Rochelle
La Rochelle
Centre Hospitalier de Versailles
Le Chesnay, 78150
Centre Hospitalier Universitaire de Lille
Lille
Centre Hospitalier Universitaire Hôpital Edouard Herriot
Lyon
Hôpital privé Jacques Cartier
Massy
Groupe Hospitalier Sud Ile-de-France
Melun
Centre Hospitalier Régional d'Orléans
Orléans
Centre Hospitalier Universitaire Cochin
Paris
Groupe hospitalier Paris Saint-Joseph
Paris
Hôpital Fondation Adolphe de Rothschild
Paris
Hopital Privé Claude Galien
Quincy-sous-Sénart
Centre Hospitalier Universitaire de Rennes
Rennes
Centre Hospitalier de Roanne
Roanne
Hopital Foch
Suresnes
Centre Hospitalier de Toulon
Toulon
Centre Hospitalier Universitaire de Toulouse
Toulouse
Centre Hospitalier Universitaire de Tours
Tours
Gustave-Roussy
Villejuif
United States2 sites
Wellstar Atlanta Medical Center
Atlanta, Georgia, 30312
Jackson Memorial Health System; University of Miami, Miller School of Medicine
Miami, Florida, 33136
About this study
Official title: Outcomes in Patients With Acute Encephalopathy and SARS-Cov-2 Infection
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.
Read more
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.
Read the 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)
- Conditions
- COVID-19, Encephalopathy, Critically Ill
- Being tested
- Follow up
- Medical subject headings
- COVID-19, Brain Diseases, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow upOther
Follow up up to day 90 (Glasgow outcome scale, Glasgow outcome scale extended, functionnal impairments : Barthel index, Disability Rating Scale)
| Study group | Role | What they receive |
|---|---|---|
| Follow up | Follow up of all included patients up to 3 months after enrollement Receives: Other: Follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at Critical/Intensive care or Neurocritical care admission
Secondary outcomes (2)
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]
Measured: 3 months
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]
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start23 Mar 2020
- Primary completion30 Sep 2020
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Ictal Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephane LEGRIEL, MD, PhD, Principal investigator, Ictal Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320472
- Sponsor's protocol ID
- Neuro-COVID-19
- Acronym
- NeuroCOVID19
- Status last verified
- Oct 2020
- First submitted
- 22 Mar 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37041081
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes in Patients With Acute Encephalopathy and SARS-Cov-2 Infection
- ClinicalTrials.gov ID
- NCT04320472
- Acronym / sponsor ID
- NeuroCOVID19 / Neuro-COVID-19
- Conditions
- COVID-19, Encephalopathy, Critically Ill
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Ictal GroupUniversity, hospital or other
- Study start
- 23 Mar 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 25 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Follow up | – | Other: Follow upFollow up of all included patients up to 3 months after enrollement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Acute encephalopathy and ICU admission
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Opposition to study participation from the patient itself or patient surrogate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follow upFollow up up to day 90 (Glasgow outcome scale, Glasgow outcome scale extended, functionnal impairments : Barthel index, Disability Rating Scale) | Other | Follow up |
Primary outcome
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
2 secondary outcomes
Favorable outcome
Time frame: 3 months
Favorable outcome
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Derived from this study: PubMed 37041081Legriel 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephane LEGRIEL, MD, PhD principal investigator
Ictal Group
39 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Encephalopathy, run by Ictal Group at 39 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in France, United States, Brazil, Colombia, Egypt and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence (time frame: at Critical/Intensive care or Neurocritical care admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04320472, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.