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Determination of COVID-19 Related Virus in Central Nervous System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04775784
Recruitment Status : Recruiting
First Posted : March 1, 2021
Last Update Posted : March 3, 2021
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

Resource links provided by the National Library of Medicine

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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 identifier (NCT number): NCT04775784

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Contact: Laura Sincinelli 00390226435568

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IRCCS San Raffaele Scientific Institute Recruiting
Milan, Italy, 20132
Contact: Laura Sincinelli    003926435568   
Sponsors and Collaborators
IRCCS San Raffaele
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Principal Investigator: Pietro Mortini, MD, Prof. IRCCS San Raffaele Scientific Institute

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Responsible Party: Pietro Mortini, MD, Prof., Professor, IRCCS San Raffaele 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:
CNS infection
Additional relevant MeSH terms:
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Central Nervous System Infections
Central Nervous System Diseases
Respiratory Tract Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Nervous System Diseases