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Neurological Outcome After SARS-CoV-2 Infection (ATTRACT)

2021년 8월 23일 업데이트: Medical University Innsbruck

Long-term Neurological Outcome After SARS-CoV-2 Infection

Wider research context: Since the recognition of SARS-CoV-2 outbreak in 2019, there are now over 126 million COVID-19 cases worldwide with more than 2.7 million deaths. Reports on neurological manifestations vary in prevalence rates (6-84%) and range from mild (headache, hyposmia, myalgia) to severe (encephalopathy, strokes, seizures). Little is known about long-term neurological outcomes of COVID-19 patients. The investigators propose a structured protocol to capture persistent and delayed neurological manifestations, neurocognitive deficits and quality of life (QoL) 3 and 12 months after COVID-19. Objectives: The investigators hypothesize that neurological manifestations and neuropsychological/cognitive deficits can be detected after COVID-19, substantially impact on patients' QoL and can be correlated with structural neuroimaging findings. Main objectives are to assess firstly long-term prevalence rates and natural history of neurological manifestations, secondly neuropsychological/cognitive deficits after COVID-19, thirdly the impact of COVID-19 on measures of mental health, QoL and functional outcome, fourthly to correlate neurological manifestations and distinct neurocognitive deficits with structural MRI abnormalities, and Fifthly to compare these results to age- and sex matched controls hospitalized with pneumonia (Cpneum) and to healthy controls for MRI-data (Chealthy). Approach: The investigators aim to enrol at least 225 patients with COVID-19, in addition to 50 Cpneum and 80 Chealthy. COVID-19 patients will include (group Oóne) outpatients presenting to the hospital, (group two) in-patients not requiring ICU admission, and (group three) patients admitted to the ICU. The investigators will not include asymptomatic patients, patients not presenting to the hospital, and those who do not consent to participate. The standardized protocol includes a firstly a structured neurological examination, secondly olfactory testing, thirdly assessment of QoL, mental health and functional outcome at 3 and 12 months, and fourthly screening for cognitive deficits (at 3 months) and a structured neuropsychological testing (at 12 months) in COVID-19 patients and controls. In a subset of at least 120 COVID-19 patients and 50 controls (Cpneum) high field MRI will be performed at 3 and 12 months. Innovation: The investigators aim to quantify COVID-19 related and specific neurological manifestations and their impact on the individual health condition. The novelty lies in the prospective design, the longitudinal follow-up including and the inclusion of a control group which allows us to explore the natural history of COVID-19 related neurological manifestations. Preliminary analysis of our ongoing 3-month follow-up suggests persistent neurological manifestations and a significant impact of COVID-19 on mental health, cognition and QoL. The investigators believe that our study results likely influence the long-term care of COVID-19 patients and help to identify those, who need further neuro-rehabilitative support

연구 개요

연구 유형

관찰

등록 (예상)

355

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Tyrol
      • Innsbruck, Tyrol, 오스트리아, 6020
        • 모병
        • Medical University Innsbruck, Department of Neurology
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

확률 샘플

연구 인구

We aim to include a full dataset of at least 180 patients undergoing 3- and 12-month follow-up. Due to an estimated dropout rate of ~20%, approximately 225 patients are planned to be included in 3-month follow-up. Out of these, we estimate to include a minimum of 50 patients in each of the 3 pre-defined groups, which is feasible based on the preliminary analysis of patient distribution: severe patients: 25%, moderate patients: 50% and mild patients: 25%. In addition, we aim to include at least 120 patients in the MRI sub-study. For the control group, we plan to include 50 age- and sex matched patients (n=25 normal ward, n=25 ICU admission) who undergo the same 3- and 12-month study protocol including MR imaging and neurocognitive testing as COVID-19 patients. Out of these, we expect an estimated dropout rate of ~10% at the 12-month follow-up resulting in 40 patients who will completely finish the study protocol.

설명

Inclusion Criteria:

  • (1) Patients of either sex, aged ≥18 years with
  • (2) confirmed SARS-CoV-2 infection (according to the Austrian Federal Ministry of Social Affairs, Health, Care and Consumer Protection),
  • (3) signed and dated declaration of consent by the patient according to ICH-GCP Guidelines,
  • (4) being able to speak and understand the German language

Exclusion Criteria:

  • (1) Pre-existing dementia,
  • (2) confirmed pregnancy,
  • (3) patients without the capacity to consent,
  • (4) asymptomatic patients,
  • (5) patients not presenting to the hospital

Specific Inclusion/exclusion criteria for the MRI substudy

Inclusion criteria:

  • (1) Patients of either sex, aged ≥18 years with
  • (2) confirmed SARS-CoV-2 infection (according to the Austrian Federal Ministry of Social Affairs, Health, Care and Consumer Protection),
  • (3) signed and dated declaration of consent by the patient according to ICH-GCP Guidelines,
  • (4) being able to speak and understand the German language
  • (5) agree to participate for MRI

Exclusion criteria:

  • (1) Pre-existing dementia,
  • (2) confirmed pregnancy,
  • (3) patients without the capacity to consent,
  • (4) asymptomatic patients,
  • (5) patients not presenting to the hospital
  • (6) definite contraindication to MRI (e.g. pacemakers)

Controls Patients after pneumonia (Cpneum) We will enrol at least 50 hospitalized age- and sex matched patients with pneumonia based on disease severity during the acute disease as: (group One) hospitalized (moderate; n=25) and (group two) severe patients admitted to the ICU for mechanical ventilation (n=25).

Inclusion criteria:

  • (1) Patients of either sex, aged ≥18 years with
  • (2) bacterial pneumonia according to CDC criteria,
  • (3) signed and dated declaration of consent by the patient according to ICH-GCP Guidelines, and
  • (4) being able to speak and understand the German language,
  • (5) agree to participate for MRI

Exclusion criteria:

  • (1) Pre-existing dementia,
  • (2) confirmed pregnancy,
  • (3) patients without the capacity to consent,
  • (4) definite contraindication to MRI (e.g. pacemakers)

Healthy referents (Chealthy) Currently n=38 MRI acquisitions of prospectively recruited healthy individuals are available, fulfilling the criteria of this proposal (age- and sex matched; same MR protocol). This cohort will be prospectively extended by n=42 to reach age and sex matched criteria.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: 케이스 컨트롤
  • 시간 관점: 유망한

코호트 및 개입

그룹/코호트
개입 / 치료
C healthy
Healthy control group
No Intervention takes place, Patients are being observed and classified according to disease severity
다른 이름들:
  • 관찰
C pneum
Control group of patients who were hospitalised and diagnosed with pneumonia ( COVID-19 pneumonia excluded)
No Intervention takes place, Patients are being observed and classified according to disease severity
다른 이름들:
  • 관찰
Mild
Outpatients presenting to the hospital with COVID-19
No Intervention takes place, Patients are being observed and classified according to disease severity
다른 이름들:
  • 관찰
Moderate
In-patients with COVID-19 not requiring ICU admission
No Intervention takes place, Patients are being observed and classified according to disease severity
다른 이름들:
  • 관찰
Severe
Patients with COVID-19 admitted to the ICU
No Intervention takes place, Patients are being observed and classified according to disease severity
다른 이름들:
  • 관찰

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Prevalence of neurological manifestations in COVID-19 patients
기간: 3-months
3-month prevalence of neurological manifestations in COVID-19 patients presenting to the hospital in comparison to control patients (Cpneum)
3-months
Prevalence of neurological manifestations in COVID-19 patients
기간: 12-months
12-month prevalence of neurological manifestations in COVID-19 patients presenting to the hospital in comparison to control patients (Cpneum)
12-months

2차 결과 측정

결과 측정
측정값 설명
기간
Association, prevalence and classification of neurologic manifestations with structural neuroimaging in hospitalised COVID-19 patients after 3-months.
기간: 3-months
Association of neurologic manifestations (specifically neuropsychological deficits and smelling deficits) with structural neuroimaging (high-field MRI) in comparison to control patients (Cpneum). Prevalence and classification of neuroimaging abnormalities in hospitalized COVID-19 patients in comparison to controls (Cpneum and Chealthy). Other (exploratory) endpoints derived from the clinical database might be analyzed on data driven considerations 3-months after acute disease.
3-months
Association, prevalence and classification of neurologic manifestations with structural neuroimaging in hospitalised COVID-19 patients after 12-months.
기간: 12-months
Association of neurologic manifestations (specifically neuropsychological deficits and smelling deficits) with structural neuroimaging (high-field MRI) in comparison to control patients (Cpneum). Prevalence and classification of neuroimaging abnormalities in hospitalized COVID-19 patients in comparison to controls (Cpneum and Chealthy). Other (exploratory) endpoints derived from the clinical database might be analyzed on data driven considerations 12-months after acute disease.
12-months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2021년 4월 7일

기본 완료 (예상)

2023년 9월 1일

연구 완료 (예상)

2024년 9월 1일

연구 등록 날짜

최초 제출

2021년 8월 18일

QC 기준을 충족하는 최초 제출

2021년 8월 23일

처음 게시됨 (실제)

2021년 8월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 8월 27일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 8월 23일

마지막으로 확인됨

2021년 8월 1일

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사스 코로나바이러스 2에 대한 임상 시험

No Intervention에 대한 임상 시험

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