- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04377425
COVID-19 Prevalence and Cognitive Deficits in Neurological Patients (Neuro-Covid)
COVID-19 Prevalence, Morbidity and Long Term Cognitive Deficits in Consecutive Patients Presenting With Acute Neurological Symptoms
연구 개요
상세 설명
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.
연구 유형
연락처 및 위치
연구 장소
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DK
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Aalborg, DK, 덴마크, 9000
- Aalborg University Hospital
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Aarhus, DK, 덴마크, 8200
- Aarhus University Hospital
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Holstebro, DK, 덴마크, 7500
- Regional Hospital West Jutland, Hostebro
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Viborg, DK, 덴마크, 8800
- Regional Hospital Central Jutland, Viborg
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
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
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COVID-19 swap test PCR performed according to hospital standard operating procedures
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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
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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
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Prevalence of COVID-19 infection in consecutive patients with neurological symptoms
기간: 6 months
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To investigate the prevalence of COVID-19 infections in consecutive patients with acute onset of neurological symptoms (with or without prior neurological disease)
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6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Three months cognitive function of COVID-19 positive patients
기간: 3 months
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Three months cognitive function (Montreal Cognitive Assessment) of COVID-19 positive patients compared to COVID-19 negative patients
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3 months
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Clinical presentation of neurological symptoms in COVID-19 positive patients
기간: 6 months
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Characterization of the neurological symptoms in neurological COVID-19 positive patients (exploratory endpoint)
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6 months
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Prevalence of pre- and asymptomatic COVID-19 positive patients in acutely admitted neurological patients
기간: 6 months
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Prevalence of pre-symptomatic and asymptomatic COVID-19pos in acutely admitted patients with a primary complaint of neurological symptoms.
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6 months
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Anosmia in COVID-19 positive patients
기간: 6 months
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Prevalence of anosmia in COVID-19pos patients compared to COVID-19neg patients
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6 months
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Exploratory analysis on neuro-specific and inflammatory blood and cerebrospinal fluid markers of COVID-19 infection
기간: 24 months
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Neuro-specific and inflammatory blood- and cerebrospinal fluid markers in COVID-19 positive patients compared to COVID-19 negative matched controls
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24 months
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Exploratory analysis of the coagulation profile of COVID-19 positive patients compared to COVID-19neg patients
기간: 24 months
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Functional and immunologic plasma assays will be employed to analyze proteins and pathways in coagulation and fibrinolysis
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24 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Grethe Andersen, MD, Aarhus University Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Neuro-Covid-19
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
뇌졸중, 급성에 대한 임상 시험
COVID-19 swap test PCR에 대한 임상 시험
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Texas Cardiac Arrhythmia Research Foundation알려지지 않은
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University Hospital, Lille모병
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King's College LondonZoe Global Limited; Department of Health, United Kingdom모병
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Centre Hospitalier Universitaire, AmiensUniversity Hospital, Rouen; University Hospital, Montpellier; Central Hospital, Nancy, France 그리고 다른 협력자들모집하지 않고 적극적으로
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Acibadem University완전한
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University Hospital, Lille모병