Determination of COVID-19 Related Virus in Central Nervous System

Recruiting

• Conditions: COVID-19 Testing; CNS Disease; CNS Infection
• Interventions: Diagnostic Test: Determination of SARS-CoV2 presence in CNS

• Registration Number: NCT04775784
• Lead Sponsor: IRCCS San Raffaele

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

Study Timeline

• Study Start: 2020-12-17
• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-02-25
• Study First Posted: 2021-03-01
• Primary Completion: 2022-06-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-18
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult neurosurgical patients	Determination of SARS-CoV2 presence in CNS	Adult, both sex, neurosurgical patients candidate for intracranial surgery, able to sign informed consent.

Primary Outcome Measures

Name	Time	Method
Determination of SARS-CoV-2 presence in the CNS	Surgery	Brain tissue sampling analysis

Trial Locations

Locations (1)

IRCCS San Raffaele Scientific Institute; 🇮🇹 Milan, Italy