RECOVID: Recovery After Critical Covid-19 Infection
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Outcome Measures
Primary Outcome Measures
- Cognitive function 6 months after hospital discharge [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 [6 months after hospital discharge]
Diffusion capacity DLCO results (percentage of predicted) 6 months after ICU treatment for covid-19
- Incidence of post myocarditis findings in MRI of the heart [6-12 months after hospital discharge]
Incidence of findings in cardiac MRI indicating previous myocarditis in each group
- Six minute walk test distance [6 months after hospital discharge]
The distance in meters walked by ICU treated patients in 6 minutes in controlled test environment
- Restriction in lung function tests [6 months after hospital discharge]
Restriction in lung function parameters vital capacity and forced vital capacity (z-scores) in measured by spirometry
- Cerebral microbleeds [6 months after hospital discharge]
Number and anatomical distribution of cerebral microbleeds in MRI imaging of the brain
- Plasma matrix metalloproteinases -8, -9 and TIMP-1 6 months after hospital discharge [6 moths after hospital discharge]
Plasma matrix metalloproteinases -8, -9 and TIMP-1 levels in ng/mL 6 months after hospital discharge
- Plasma neurofilament level and its correlation with global score in neuropsychological test battery [6 months after hospital discharge]
Plasma neurofilament level and its correlation with global score in neuropsychological test battery
Secondary Outcome Measures
- Correlation ApoE 4 alleles with disease severity [6 months post-covid]
Laboratory analysis of ApoE alleles and comparison of their frequencies among groups
- Correlation of cerebral microbleeds with neuropsychological global score [6 moths after hospital discharge]
Correlation of type and location of cerebral microbleeds with neuropsychological global score
- Association of the incidence of cerebral microbleeds with findings in cardiac MRI [6-12 months after hospital discharge]
Association of the incidence of cerebral microbleeds with findings in cardiac MRI
- Correlation of plasma neurofilament with cerebral microbleeds [6 months after hospital discharge]
Correlation of plasma neurofilament with cerebral microbleeds in brain MR imaging
- Correlation of 6 minute walk test heart rate variables with cardiac function [6-12 months after hospital discharge]
Correlation of heart rate in rest, exercise and 5 minutes after exercise with cardiac output measured in heart MRI
- Correlation of matrix metalloproteinase 9 with diffusion capacity [6 months after hospital discharge]
Correlation of matrix metalloproteinase 9 (ng/mL) with lung diffusion capacity z-score
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18-100
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Positive PCR for Sars-CoV-2 (except non-covid controls, who must be negative)
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Native language Finnish or Swedish
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Informed consent to study to study participation
Exclusion Criteria:
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Age under 18
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Pregnant or lactating
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Major neurologic diagnosis (TBI, dementia, stroke, Parkinson´s disease before covid-19)
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Substantially impaired hearing or vision
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Developmental disability.
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No consent to study participation
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Contraindication to MR imaging (such as cardiac pacemaker, allergy to contrast)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Helsinki University Hospital | Helsinki | Capital Province Of Finland | Finland | 00290 |
Sponsors and Collaborators
- University of Helsinki
- Uppsala University
- Göteborg University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUS/1949/2020