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COVID-19 Prevalence and Cognitive Deficits in Neurological Patients (Neuro-Covid)

2020年9月1日 更新者:Grethe Andersen、Aarhus University Hospital

COVID-19 Prevalence, Morbidity and Long Term Cognitive Deficits in Consecutive Patients Presenting With Acute Neurological Symptoms

The purpose is to investigate the COVID-19 prevalence, associated morbidity and long-term cognitive deficits in consecutive patients presenting with acute neurological symptoms

調査の概要

詳細な説明

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is spreading in nearly every country in the world. Patients with coronavirus disease 2019 (COVID-19) typically present with cough, fever and respiratory illness. In another coronavirus (SARS-COV-1) causing the SARS outbreak in 2002 to 2003, neurons have been found to be highly susceptible for infection and the virus can cause extensive neuronal damage with only minimal respiratory affection. Similar to SARS-CoV-1, COVID-19 virus exploits the angiotensin-converting enzyme 2 (ACE-2) receptor to gain entry and infect cells. Both glial and neurons express ACE-2 receptors and makes them potential targets, however the neurotropic potential in humans remain largely undescribed. Neurological manifestations of COVID-19 have only been sporadically described in single or short series of case reports together with a case of COVID-19 RNA in the cerebrospinal fluid.

Loss of smell (anosmia) may be a presenting symptom in COVID-19. Interestingly, in a study from Italy anosmia was present in 19,4% and not typical accompanied by nasal obstruction, rhinitis or sinusitis, making direct damage and invasion of the olfactory nerve more likely. A Chinese study have found that 36.6% of COVID-19 patients experience neurological symptoms and that severely affected COVID-19 patients reported more neurological symptoms.

In general, neurological manifestations to viral disease may occur as a direct result of viral invasion and damage to either the central or peripheral nervous system or from an immune mediated neurological damage either during (para) or after (post) the viral infection. Furthermore, the inflammation in itself can increase the risk of arterial thrombosis and thus ischemic stroke.

Early reports from Italy stresses the need to pay attention to neurological symptoms, as they are often neglected due to the systemic and respiratory impairment. Further, concerning reports from the Center for Disease Control (CDC) in USA, have estimated that out of COVID-19pos patients up to 46.5% may be asymptomatic/pre-symptomatic and 17,5% never develop classical COVID-19 symptoms. The COVID-19 infection is likely to be missed if patients present with symptoms from another organ system. Moreover, it poses a transmission risk for other admitted patients and healthcare workers and a risk that a possible association between e.g. neurological symptoms/diseases and a COVID-19 infection are missed. The role and presence of COVID-19 infection in patients presenting with acute neurological symptoms is currently unknown.

研究の種類

観察的

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • DK
      • Aalborg、DK、デンマーク、9000
        • Aalborg University Hospital
      • Aarhus、DK、デンマーク、8200
        • Aarhus University Hospital
      • Holstebro、DK、デンマーク、7500
        • Regional Hospital West Jutland, Hostebro
      • Viborg、DK、デンマーク、8800
        • Regional Hospital Central Jutland, Viborg

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

Base study: Consecutive patients with acute neurological disease admitted at the Neurology department at Aarhus University Hospital will be tested with a nasopharyngeal swap for SARS-COVID-19 RNA

Extended study: Patients fulfilling the extended study criteria will be asked to participate in extended study depending on their COVID-19 status and whether study criteria are fulfilled

説明

Eligibility criteria for the extended study:

Inclusion Criteria:

  • Adult patients
  • New onset of neurological symptoms
  • Independent in daily activities (modified Rankin Scale ≤ 2)
  • Stroke or epilepsy/seizure

Exclusion Criteria:

  • Pre-existing neurodegenerative disease
  • Diagnosed with cerebral neoplasm
  • Pre-existing expected life expectancy < 3 months
  • Suspected non-organic (functional) disorder

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
Patients with acute neurological symptoms
Consecutive patients with acute neurological disease admitted at the Neurology departments will be tested with a nasopharyngeal swap for SARS-COVID-19 RNA according to standard operating procedures at the department (if estimated hospital stay is >24hours). Medical and clinical characteristics will be collected
COVID-19 swap test PCR performed according to hospital standard operating procedures
Stroke patients

COVID-19 positive patients will be asked to participate in the extended study together with matched COVID-19 negative controls.

Extended study: Collection of cerebrospinal fluid and blood-samples, clinical and cognitive assessment at baseline and at 3-month follow-up

COVID-19 swap test PCR performed according to hospital standard operating procedures
Seizure/epilepsy

COVID-19 positive patients will be asked to participate in the extended study together with matched COVID-19 negative controls.

Extended study: Collection of cerebrospinal fluid and blood-samples, clinical and cognitive assessment at baseline and at 3-month follow-up

COVID-19 swap test PCR performed according to hospital standard operating procedures

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Prevalence of COVID-19 infection in consecutive patients with neurological symptoms
時間枠:6 months
To investigate the prevalence of COVID-19 infections in consecutive patients with acute onset of neurological symptoms (with or without prior neurological disease)
6 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Three months cognitive function of COVID-19 positive patients
時間枠:3 months
Three months cognitive function (Montreal Cognitive Assessment) of COVID-19 positive patients compared to COVID-19 negative patients
3 months
Clinical presentation of neurological symptoms in COVID-19 positive patients
時間枠:6 months
Characterization of the neurological symptoms in neurological COVID-19 positive patients (exploratory endpoint)
6 months
Prevalence of pre- and asymptomatic COVID-19 positive patients in acutely admitted neurological patients
時間枠:6 months
Prevalence of pre-symptomatic and asymptomatic COVID-19pos in acutely admitted patients with a primary complaint of neurological symptoms.
6 months
Anosmia in COVID-19 positive patients
時間枠:6 months
Prevalence of anosmia in COVID-19pos patients compared to COVID-19neg patients
6 months
Exploratory analysis on neuro-specific and inflammatory blood and cerebrospinal fluid markers of COVID-19 infection
時間枠:24 months
Neuro-specific and inflammatory blood- and cerebrospinal fluid markers in COVID-19 positive patients compared to COVID-19 negative matched controls
24 months
Exploratory analysis of the coagulation profile of COVID-19 positive patients compared to COVID-19neg patients
時間枠:24 months
Functional and immunologic plasma assays will be employed to analyze proteins and pathways in coagulation and fibrinolysis
24 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Grethe Andersen, MD、Aarhus University Hospital

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (予想される)

2020年5月7日

一次修了 (予想される)

2020年11月29日

研究の完了 (予想される)

2022年6月30日

試験登録日

最初に提出

2020年4月29日

QC基準を満たした最初の提出物

2020年5月5日

最初の投稿 (実際)

2020年5月6日

学習記録の更新

投稿された最後の更新 (実際)

2020年9月3日

QC基準を満たした最後の更新が送信されました

2020年9月1日

最終確認日

2020年9月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

IPD プランの説明

Upon reasonable request

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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