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Determination of COVID-19 Related Virus in Central Nervous System

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ClinicalTrials.gov Identifier: NCT04775784
Recruitment Status : Recruiting
First Posted : March 1, 2021
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Pietro Mortini, MD, Prof., 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.

Condition or disease Intervention/treatment
COVID-19 Testing CNS Disease CNS Infection Diagnostic Test: Determination of SARS-CoV2 presence in CNS

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

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determination of SARS-Cov-2 Virus in Central Nervous System
Actual Study Start Date : December 17, 2020
Estimated Primary Completion Date : September 20, 2022
Estimated Study Completion Date : December 20, 2022

Group/Cohort Intervention/treatment
Adult neurosurgical patients
Adult, both sex, neurosurgical patients candidate for intracranial surgery, able to sign informed consent.
Diagnostic Test: Determination of SARS-CoV2 presence in CNS
Brain tissue sampling




Primary Outcome Measures :
  1. Determination of SARS-CoV-2 presence in the CNS [ Time Frame: Surgery ]
    Brain tissue sampling analysis


Biospecimen Retention:   Samples With DNA
Brain tissue samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients eligible to CNS surgery
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04775784


Contacts
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Contact: Laura Sincinelli 00390226435568 sincinelli.laura@hsr.it

Locations
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Italy
IRCCS San Raffaele Scientific Institute Recruiting
Milan, Italy, 20132
Contact: Laura Sincinelli    003926435568    sincinelli.laura@hsr.it   
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
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Principal Investigator: Pietro Mortini, MD, Prof. IRCCS San Raffaele Scientific Institute
Publications:

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Responsible Party: Pietro Mortini, MD, Prof., Professor, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT04775784    
Other Study ID Numbers: NCH08-2020
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pietro Mortini, MD, Prof., IRCCS San Raffaele:
SARS-Cov-2
CNS infection
Coronavirus
Brain
Additional relevant MeSH terms:
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Central Nervous System Diseases
Central Nervous System Infections
Nervous System Diseases