<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04418609</url>
  </required_header>
  <id_info>
    <org_study_id>Neuro-COVID-19</org_study_id>
    <nct_id>NCT04418609</nct_id>
  </id_info>
  <brief_title>Neuro-COVID-19: Neurological Complications of COVID-19</brief_title>
  <acronym>Neuro-COVID</acronym>
  <official_title>Neuro-COVID-19: Neurological Complications of COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emanuela Keller</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The prevalence and typical patterns of neurological complications in hospitalized COVID-19&#xD;
      patients admitted to the intensive care units of the University Hospital Zurich will be&#xD;
      investigated. The impact of neurological complications among COVID-19 patients on mortality,&#xD;
      functional outcome, and organizational outcomes will be analyzed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospective observational cohort study to document prevalence and severity of&#xD;
      neurological symptoms among patients requiring critical care admission for confirmed novel&#xD;
      coronavirus disease (COVID-19). COVID-19 is classified as severe acute respiratory syndrome 2&#xD;
      (SARS-CoV-2) and shares significant structural and biological similarities with SARS-CoV,&#xD;
      which has neuroinvasive properties and brainstem involvement. Early reports of COVID-19&#xD;
      progression indicate presence of severe neurological complications, including seizures, coma,&#xD;
      encephalitis, and cerebrovascular events including ischemic stroke, intracranial hemorrhage,&#xD;
      and cerebral venous sinus thromboses. In addition, recent data from Zika-virus and H1N1&#xD;
      influenza pandemics reveal a high incidence of neurological complications, including Guillain&#xD;
      Barré syndrome and neonatal microcephaly for Zika-virus and narcolepsy with H1N1 infections.&#xD;
      Early reports from China suggest neurological symptoms may occur in approximately 36% of&#xD;
      SARS-CoV-2 positive patients, with increased prevalence among more severe cases, and fall&#xD;
      into three categories: central nervous system symptoms or diseases, peripheral nervous system&#xD;
      symptoms, and skeletal muscular symptoms. However, the exact prevalence of these conditions&#xD;
      and impact on patient disease severity and outcomes is unknown. As the incidence and severity&#xD;
      of COVID-19 infection continues to rapidly rise on an international level, it is imperative&#xD;
      to capture prospective data to accurately document prevalence, severity and clinical&#xD;
      characterization of neurological components of COVID-19, the influence of treatment regimens&#xD;
      of neurological complications, and role of these confounders on patient and organizational&#xD;
      outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Actual">June 9, 2022</completion_date>
  <primary_completion_date type="Actual">June 9, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of neurological complications</measure>
    <time_frame>through study completion, on an average of 3 weeks</time_frame>
    <description>Determine the prevalence of neurological complications in hospitalized COVID-19 patients admitted to the intensive care unit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence and outcome of severe neurological complications</measure>
    <time_frame>through study completion, on an average of 3 weeks</time_frame>
    <description>Examine if empiric COVID-19 therapies are associated with difference in the prevalence and outcome of severe neurological complications of COVID-19.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Impact of neurological complications</measure>
    <time_frame>through study completion, on an average of 3 weeks</time_frame>
    <description>Determine the impact of neurological complications among COVID-19 patients on mortality, functional outcome, and organizational outcomes (ICU length of stay, hospital length of stay) among patients with confirmed COVID-19.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Characteristic patterns in cerebral imaging and electroencephalography (EEG), as well as cerebrospinal fluid (CSF)</measure>
    <time_frame>through study completion, on an average of 3 weeks</time_frame>
    <description>Analyze characteristic patterns in cerebral imaging and electroencephalography (EEG), as well as cerebrospinal fluid (CSF) of patients, in whom a lumbar puncture has been performed for clinical reasons</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brain for pathological changes and histopathological findings (if patient dies).</measure>
    <time_frame>through study completion, on an average of 3 weeks</time_frame>
    <description>Analyze the brain for pathological changes and histopathological findings, if the patient dies.</description>
  </primary_outcome>
  <enrollment type="Actual">8</enrollment>
  <condition>Neurologic Complication</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>further processing of health data</intervention_name>
    <description>further processing of biological materials and health related personal data for research</description>
    <other_name>further processing of biological materials and health related personal data</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients admitted to the Intensive Care Units (ICUs) of the Institute of Intensive Care&#xD;
        Medicine, University Hospital of Zurich meeting eligibility criteria during the pandemic&#xD;
        will be enrolled.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults (age &gt; 18 years old) treated at ICUs&#xD;
&#xD;
          -  Admitted with confirmed COVID-19 infection&#xD;
&#xD;
          -  Patient exhibiting acute neurological manifestations&#xD;
&#xD;
          -  General consent of the Institute of Intensive Care Medicine available from patient or&#xD;
             legal representative&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-existing severe neurologic dysfunction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emanuela Keller, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Zürich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Zurich</name>
      <address>
        <city>Zürich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>August 3, 2022</last_update_submitted>
  <last_update_submitted_qc>August 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Zurich</investigator_affiliation>
    <investigator_full_name>Emanuela Keller</investigator_full_name>
    <investigator_title>Prof. Dr. Emanuela Keller</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04418609
org study id: Neuro-COVID-19
nct id: NCT04418609
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The prevalence and typical patterns of neurological complications in hospitalized COVID-19
      patients admitted to the intensive care units of the University Hospital Zurich will be
      investigated. The impact of neurological complications among COVID-19 patients on mortality,
      functional outcome, and organizational outcomes will be analyzed.
This study is a prospective observational cohort study to document prevalence and severity of
      neurological symptoms among patients requiring critical care admission for confirmed novel
      coronavirus disease (COVID-19). COVID-19 is classified as severe acute respiratory syndrome 2
      (SARS-CoV-2) and shares significant structural and biological similarities with SARS-CoV,
      which has neuroinvasive properties and brainstem involvement. Early reports of COVID-19
      progression indicate presence of severe neurological complications, including seizures, coma,
      encephalitis, and cerebrovascular events including ischemic stroke, intracranial hemorrhage,
      and cerebral venous sinus thromboses. In addition, recent data from Zika-virus and H1N1
      influenza pandemics reveal a high incidence of neurological complications, including Guillain
      Barré syndrome and neonatal microcephaly for Zika-virus and narcolepsy with H1N1 infections.
      Early reports from China suggest neurological symptoms may occur in approximately 36% of
      SARS-CoV-2 positive patients, with increased prevalence among more severe cases, and fall
      into three categories: central nervous system symptoms or diseases, peripheral nervous system
      symptoms, and skeletal muscular symptoms. However, the exact prevalence of these conditions
      and impact on patient disease severity and outcomes is unknown. As the incidence and severity
      of COVID-19 infection continues to rapidly rise on an international level, it is imperative
      to capture prospective data to accurately document prevalence, severity and clinical
      characterization of neurological components of COVID-19, the influence of treatment regimens
      of neurological complications, and role of these confounders on patient and organizational
      outcomes.
observational model: Cohort
time perspective: Other
measure: Prevalence of neurological complications
time frame: through study completion, on an average of 3 weeks
description: Determine the prevalence of neurological complications in hospitalized COVID-19 patients admitted to the intensive care unit.
measure: Prevalence and outcome of severe neurological complications
time frame: through study completion, on an average of 3 weeks
description: Examine if empiric COVID-19 therapies are associated with difference in the prevalence and outcome of severe neurological complications of COVID-19.
measure: Impact of neurological complications
time frame: through study completion, on an average of 3 weeks
description: Determine the impact of neurological complications among COVID-19 patients on mortality, functional outcome, and organizational outcomes (ICU length of stay, hospital length of stay) among patients with confirmed COVID-19.
measure: Characteristic patterns in cerebral imaging and electroencephalography (EEG), as well as cerebrospinal fluid (CSF)
time frame: through study completion, on an average of 3 weeks
description: Analyze characteristic patterns in cerebral imaging and electroencephalography (EEG), as well as cerebrospinal fluid (CSF) of patients, in whom a lumbar puncture has been performed for clinical reasons
measure: Brain for pathological changes and histopathological findings (if patient dies).
time frame: through study completion, on an average of 3 weeks
description: Analyze the brain for pathological changes and histopathological findings, if the patient dies.
intervention type: Other
intervention name: further processing of health data
description: further processing of biological materials and health related personal data for research
other name: further processing of biological materials and health related personal data
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Emanuela Keller, Prof. Dr.
role: Principal Investigator
affiliation: University Hospital, Zürich
facility: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: University of Zurich
investigator full name: Emanuela Keller
investigator title: Prof. Dr. Emanuela Keller
mesh term: COVID-19
sharing ipd: No