Clinical trial NCT04775784: Determination of COVID-19 Related Virus in Central Nervous System
Official title: Determination of SARS-Cov-2 Virus in Central Nervous System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Testing
CNS Disease
CNS Infection
Keywords: SARS-Cov-2
CNS infection
Coronavirus
Brain
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients eligible to CNS surgery

Brief summary: Coronavirus disease 2019 (COVID-19) is a highly infectious pandemic disease caused by SARS-CoV-2 virus. Central Nervous System (CNS) complications associated with COVID-19 might be secondary sequelae due to exuberant systemic innate-mediated hyper-inflammation, which may impair neurovascular endothelial function, disrupt blood brain barrier (BBB), activates CNS innate immune signaling pathways, and induces parainfectious autoimmunity, potentially contributing to the CNS manifestations. Although the predominant clinical manifestation of SARS-CoV-2 is characterized by dyspnea, unremitting fever and hypoxemic respiratory failure, neurologic manifestations do occur in most hospitalized SARS-CoV-2 patients and include non-specific encephalopathy, psychosis, meningitis/encephalitis, myelitis, cerebrovascular events, Guillain-Barre' syndrome, and cranial or peripheral neuropathies, such as anosmia and ageusia. To date, data about primary CNS involvement due to neurotropism and direct neuroinvasion are still lacking.

Detailed description: Determination of SARS-CoV-2 presence in central nervous system

Eligibility criteria: Inclusion Criteria:

* Adult patients
* Patients candidate for CNS surgery
* Patients who have been tested for nasopharyngeal swab for SARS-CoV-2
* Patients who have been tested for serology test for anti SARS-CoV-2 immunoglobulinG (IgG) and immunoglobulinM (IgM) antibodies
* Patients able to sign informed consent

Exclusion Criteria:

* Patients not meeting inclusion criteria

Primary outcomes:
measure: Determination of SARS-CoV-2 presence in the CNS
timeFrame: Surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele Scientific Institute
Study officials:
affiliation: IRCCS San Raffaele Scientific Institute
name: Pietro Mortini, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
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