Recovery After Critical Covid-19 Infection (RECOVID)
研究概览
地位
条件
详细说明
Eligible patients who have been treated in the intensive care units of Helsinki University Hospital are invited to participate. Controls are recruited from follow-up clinics, and with announcements in media and websites.
The participants receive an invitation to a follow-up clinic where their experiences from the ICU treatment and recovery will be discussed. The investigators will perform neuropsychologic testing (6 months post-discharge), a telephone interview (3 months) and send written questionnaires (3, 6 and 24 months) to the participants. The participants will undergo MRI imaging of the brain and laboratory tests will be taken. The olfactory function will be tested at a follow-up clinic. Data on the patients´ respiratory function from clinical spirometry and diffusion capacity testing 3 and 6 months after discharge are collected. The patients will perform a 6 min walk test.
Data on coagulation laboratory values will be registered from acute phase and 6 months after discharge. The investigators will also analyse ApoE alleles, neurofilament light and NAD-metabolites and study their correlation with neuropsychologic findings and long term symptoms (up to 5 years after hospital discharge).
Participants will also undergo magnetic resonance imaging of the heart at 6-12 months after the hospital discharge, and laboratory samples, a symptom questionnaire and electrocardiogram are collected. Inflammatory parameters and variables associated with regulating inflammation and coagulation will be analysed.
Clinical data from the acute and post-acute phase and demographic data are collected from the patient data management systems.
The target patient number is 75 intensive care treated patients and 50 control persons in each three control group.
研究类型
注册 (预期的)
联系人和位置
学习地点
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Capital Province Of Finland
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Helsinki、Capital Province Of Finland、芬兰、00290
- Helsinki University Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Age 18-100
- Positive PCR for Sars-CoV-2 (except non-covid controls, who must be negative)
- Native language Finnish or Swedish
- Informed consent to study to study participation
Exclusion Criteria:
- Age under 18
- Pregnant or lactating
- Major neurologic diagnosis (TBI, dementia, stroke, Parkinson´s disease before covid-19)
- Substantially impaired hearing or vision
- Developmental disability.
- No consent to study participation
- Contraindication to MR imaging (such as cardiac pacemaker, allergy to contrast)
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Patients: ICU treated covid-19 patients
Neuropsychologic testing Respiratory function testing, chest x-ray and 6 minute walk test MRI of the brain and heart Laboratory tests Olfactory function tests Neuropsychology questionnaires
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Control group 1, covid-19 patients treated in the regular wards
As above, without 6 minute walk test or routine chest x-ray
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Control group 2, persons with covid-19 without hospitalization
As above, but without respiratory testing
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Control group 3, non-covid controls
As control group 2
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Cognitive function 6 months after hospital discharge
大体时间:6 months after hospital discharge
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Global score calculated from three domains: memory, executive functions and attention.Memory: WMS-III Word list delayed recall + WMS-III Logical memory delayed recall + Rey Complex Figure, delayed recall Executive: TMB (time, reversed) + Stroop interference (time, reversed) + FAB score Attention: WAIS-IV Coding + CPT (correct items) + Stroop naming (time, reversed) The global score will be compared with controls and age matched national references
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6 months after hospital discharge
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Diffusion capacity 6 months after hospital discharge
大体时间:6 months after hospital discharge
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Diffusion capacity DLCO results (percentage of predicted) 6 months after ICU treatment for covid-19
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6 months after hospital discharge
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Incidence of post myocarditis findings in MRI of the heart
大体时间:6-12 months after hospital discharge
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Incidence of findings in cardiac MRI indicating previous myocarditis in each group
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6-12 months after hospital discharge
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Six minute walk test distance
大体时间:6 months after hospital discharge
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The distance in meters walked by ICU treated patients in 6 minutes in controlled test environment
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6 months after hospital discharge
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Restriction in lung function tests
大体时间:6 months after hospital discharge
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Restriction in lung function parameters vital capacity and forced vital capacity (z-scores) in measured by spirometry
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6 months after hospital discharge
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Cerebral microbleeds
大体时间:6 months after hospital discharge
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Number and anatomical distribution of cerebral microbleeds in MRI imaging of the brain
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6 months after hospital discharge
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Plasma matrix metalloproteinases -8, -9 and TIMP-1 6 months after hospital discharge
大体时间:6 moths after hospital discharge
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Plasma matrix metalloproteinases -8, -9 and TIMP-1 levels in ng/mL 6 months after hospital discharge
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6 moths after hospital discharge
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Plasma neurofilament level and its correlation with global score in neuropsychological test battery
大体时间:6 months after hospital discharge
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Plasma neurofilament level and its correlation with global score in neuropsychological test battery
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6 months after hospital discharge
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Correlation ApoE 4 alleles with disease severity
大体时间:6 months post-covid
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Laboratory analysis of ApoE alleles and comparison of their frequencies among groups
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6 months post-covid
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Correlation of cerebral microbleeds with neuropsychological global score
大体时间:6 moths after hospital discharge
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Correlation of type and location of cerebral microbleeds with neuropsychological global score
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6 moths after hospital discharge
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Association of the incidence of cerebral microbleeds with findings in cardiac MRI
大体时间:6-12 months after hospital discharge
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Association of the incidence of cerebral microbleeds with findings in cardiac MRI
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6-12 months after hospital discharge
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Correlation of plasma neurofilament with cerebral microbleeds
大体时间:6 months after hospital discharge
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Correlation of plasma neurofilament with cerebral microbleeds in brain MR imaging
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6 months after hospital discharge
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Correlation of 6 minute walk test heart rate variables with cardiac function
大体时间:6-12 months after hospital discharge
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Correlation of heart rate in rest, exercise and 5 minutes after exercise with cardiac output measured in heart MRI
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6-12 months after hospital discharge
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Correlation of matrix metalloproteinase 9 with diffusion capacity
大体时间:6 months after hospital discharge
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Correlation of matrix metalloproteinase 9 (ng/mL) with lung diffusion capacity z-score
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6 months after hospital discharge
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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