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Neuro-COVID-19: Neurological Complications of COVID-19 (Neuro-COVID)

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.
 
ClinicalTrials.gov Identifier: NCT04418609
Recruitment Status : Recruiting
First Posted : June 5, 2020
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
Emanuela Keller, University of Zurich

Brief Summary:
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.

Condition or disease Intervention/treatment
Neurologic Complication Other: further processing of health data

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Neuro-COVID-19: Neurological Complications of COVID-19
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : May 30, 2022

Intervention Details:
  • Other: further processing of health data
    further processing of biological materials and health related personal data for research
    Other Name: further processing of biological materials and health related personal data


Primary Outcome Measures :
  1. Prevalence of neurological complications [ Time Frame: through study completion, on an average of 3 weeks ]
    Determine the prevalence of neurological complications in hospitalized COVID-19 patients admitted to the intensive care unit.

  2. Prevalence and outcome of severe neurological complications [ Time Frame: through study completion, on an average of 3 weeks ]
    Examine if empiric COVID-19 therapies are associated with difference in the prevalence and outcome of severe neurological complications of COVID-19.

  3. Impact of neurological complications [ Time Frame: through study completion, on an average of 3 weeks ]
    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.

  4. 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 ]
    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

  5. Brain for pathological changes and histopathological findings (if patient dies). [ Time Frame: through study completion, on an average of 3 weeks ]
    Analyze the brain for pathological changes and histopathological findings, if the patient dies.



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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
All patients admitted to the Intensive Care Units (ICUs) of the Institute of Intensive Care Medicine, University Hospital of Zurich meeting eligibility criteria during the pandemic will be enrolled.
Criteria

Inclusion Criteria:

  • Adults (age > 18 years old) treated at ICUs
  • Admitted with confirmed COVID-19 infection
  • Patient exhibiting acute neurological manifestations
  • General consent of the Institute of Intensive Care Medicine available from patient or legal representative

Exclusion Criteria:

  • Pre-existing severe neurologic dysfunction

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): NCT04418609


Contacts
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Contact: Emanuela Keller, Prof. Dr. 0041 44 255 56 71 emanuela.keller@usz.ch

Locations
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Switzerland
University Hospital Zurich Recruiting
Zürich, Switzerland, 8091
Contact: Emanuela Keller, Prof. Dr.         
Sponsors and Collaborators
Emanuela Keller
Investigators
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Principal Investigator: Emanuela Keller, Prof. Dr. University Hospital, Zürich
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Responsible Party: Emanuela Keller, Prof. Dr. Emanuela Keller, University of Zurich
ClinicalTrials.gov Identifier: NCT04418609    
Other Study ID Numbers: Neuro-COVID-19
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No