Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04320472 |
| Other study ID # |
Neuro-COVID-19 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| 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 |
| Health authority |
|
| 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)
