- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04864938
Recovery After Critical Covid-19 Infection (RECOVID)
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Capital Province Of Finland
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Helsinki, Capital Province Of Finland, Finland, 00290
- Helsinki University Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Cognitive function 6 months after hospital discharge
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Correlation ApoE 4 alleles with disease severity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HUS/1949/2020
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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