- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT04864938
Recovery After Critical Covid-19 Infection (RECOVID)
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
-
-
Capital Province Of Finland
-
Helsinki, Capital Province Of Finland, Finland, 00290
- Helsinki University Hospital
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
|
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
|
|
Control group 1, covid-19 patients treated in the regular wards
As above, without 6 minute walk test or routine chest x-ray
|
|
Control group 2, persons with covid-19 without hospitalization
As above, but without respiratory testing
|
|
Control group 3, non-covid controls
As control group 2
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Cognitive function 6 months after hospital discharge
Tijdsspanne: 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
|
6 months after hospital discharge
|
|
Diffusion capacity 6 months after hospital discharge
Tijdsspanne: 6 months after hospital discharge
|
Diffusion capacity DLCO results (percentage of predicted) 6 months after ICU treatment for covid-19
|
6 months after hospital discharge
|
|
Incidence of post myocarditis findings in MRI of the heart
Tijdsspanne: 6-12 months after hospital discharge
|
Incidence of findings in cardiac MRI indicating previous myocarditis in each group
|
6-12 months after hospital discharge
|
|
Six minute walk test distance
Tijdsspanne: 6 months after hospital discharge
|
The distance in meters walked by ICU treated patients in 6 minutes in controlled test environment
|
6 months after hospital discharge
|
|
Restriction in lung function tests
Tijdsspanne: 6 months after hospital discharge
|
Restriction in lung function parameters vital capacity and forced vital capacity (z-scores) in measured by spirometry
|
6 months after hospital discharge
|
|
Cerebral microbleeds
Tijdsspanne: 6 months after hospital discharge
|
Number and anatomical distribution of cerebral microbleeds in MRI imaging of the brain
|
6 months after hospital discharge
|
|
Plasma matrix metalloproteinases -8, -9 and TIMP-1 6 months after hospital discharge
Tijdsspanne: 6 moths after hospital discharge
|
Plasma matrix metalloproteinases -8, -9 and TIMP-1 levels in ng/mL 6 months after hospital discharge
|
6 moths after hospital discharge
|
|
Plasma neurofilament level and its correlation with global score in neuropsychological test battery
Tijdsspanne: 6 months after hospital discharge
|
Plasma neurofilament level and its correlation with global score in neuropsychological test battery
|
6 months after hospital discharge
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Correlation ApoE 4 alleles with disease severity
Tijdsspanne: 6 months post-covid
|
Laboratory analysis of ApoE alleles and comparison of their frequencies among groups
|
6 months post-covid
|
|
Correlation of cerebral microbleeds with neuropsychological global score
Tijdsspanne: 6 moths after hospital discharge
|
Correlation of type and location of cerebral microbleeds with neuropsychological global score
|
6 moths after hospital discharge
|
|
Association of the incidence of cerebral microbleeds with findings in cardiac MRI
Tijdsspanne: 6-12 months after hospital discharge
|
Association of the incidence of cerebral microbleeds with findings in cardiac MRI
|
6-12 months after hospital discharge
|
|
Correlation of plasma neurofilament with cerebral microbleeds
Tijdsspanne: 6 months after hospital discharge
|
Correlation of plasma neurofilament with cerebral microbleeds in brain MR imaging
|
6 months after hospital discharge
|
|
Correlation of 6 minute walk test heart rate variables with cardiac function
Tijdsspanne: 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
|
6-12 months after hospital discharge
|
|
Correlation of matrix metalloproteinase 9 with diffusion capacity
Tijdsspanne: 6 months after hospital discharge
|
Correlation of matrix metalloproteinase 9 (ng/mL) with lung diffusion capacity z-score
|
6 months after hospital discharge
|
Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HUS/1949/2020
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .