Recovery After Critical Covid-19 Infection
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Cognitive function 6 months after hospital discharge
研究概览
简要总结
The study focuses on the recovery of respiratory, cardiovascular and neurological/neuropsychological recovery after intensive care treatment for covid-19. The results will be compared with those obtained from patients treated in the regular wards for covid-19, persons with home treated covid-19 and non-covid controls.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Cognitive function 6 months after hospital discharge
时间窗: 6 months after hospital discharge
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
Diffusion capacity 6 months after hospital discharge
时间窗: 6 months after hospital discharge
Diffusion capacity DLCO results (percentage of predicted) 6 months after ICU treatment for covid-19
Six minute walk test distance
时间窗: 6 months after hospital discharge
The distance in meters walked by ICU treated patients in 6 minutes in controlled test environment
Incidence of post myocarditis findings in MRI of the heart
时间窗: 6-12 months after hospital discharge
Incidence of findings in cardiac MRI indicating previous myocarditis in each group
Cerebral microbleeds
时间窗: 6 months after hospital discharge
Number and anatomical distribution of cerebral microbleeds in MRI imaging of the brain
Restriction in lung function tests
时间窗: 6 months after hospital discharge
Restriction in lung function parameters vital capacity and forced vital capacity (z-scores) in measured by spirometry
Plasma neurofilament level and its correlation with global score in neuropsychological test battery
时间窗: 6 months after hospital discharge
Plasma neurofilament level and its correlation with global score in neuropsychological test battery
Plasma matrix metalloproteinases -8, -9 and TIMP-1 6 months after hospital discharge
时间窗: 6 moths after hospital discharge
Plasma matrix metalloproteinases -8, -9 and TIMP-1 levels in ng/mL 6 months after hospital discharge
次要结局
- Correlation of plasma neurofilament with cerebral microbleeds(6 months after hospital discharge)
- Correlation of matrix metalloproteinase 9 with diffusion capacity(6 months after hospital discharge)
- Correlation ApoE 4 alleles with disease severity(6 months post-covid)
- Correlation of cerebral microbleeds with neuropsychological global score(6 moths after hospital discharge)
- Association of the incidence of cerebral microbleeds with findings in cardiac MRI(6-12 months after hospital discharge)
- Correlation of 6 minute walk test heart rate variables with cardiac function(6-12 months after hospital discharge)
研究者
Johanna Hastbacka
Adjunct professor
University of Helsinki