- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04864938
Recovery After Critical Covid-19 Infection (RECOVID)
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
-
-
Capital Province Of Finland
-
Helsinki, Capital Province Of Finland, Finlandia, 00290
- Helsinki university hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
|
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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Cognitive function 6 months after hospital discharge
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 6 months after hospital discharge
|
Plasma neurofilament level and its correlation with global score in neuropsychological test battery
|
6 months after hospital discharge
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Correlation ApoE 4 alleles with disease severity
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 6 months after hospital discharge
|
Correlation of matrix metalloproteinase 9 (ng/mL) with lung diffusion capacity z-score
|
6 months after hospital discharge
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- HUS/1949/2020
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Covid-19
-
PfizerAttivo, non reclutanteCOVID-19 | Malattia da coronavirus 2019 (COVID-19) | Infezione da covid-19 | Vaccini contro il covid-19 | Infezione da SARS-CoV-2, COVID19 | Vaccinazione COVID-19 | Infezione da SARS-CoV-2, COVID-19 | COVID-19 (Coronavirus 2019) | Infezione da COVID-19 SARS-CoV-2Stati Uniti
-
Shanghai Public Health Clinical CenterNon ancora reclutamento
-
Duke UniversityNational Institute on Minority Health and Health Disparities (NIMHD)Completato
-
Eggensberger OHGBavarian Health and Food Safety Authority (LGL)ReclutamentoCondizione post COVID-19 | Post COVID-19 | Sindrome post COVID-19 | Sindrome lunga da COVID-19 | Condizione post COVID-19 (PCC)Germania
-
PfizerReclutamentoMalattie delle vie respiratorie | COVID-19 | Polmonite | Malattie polmonari | Malattia di coronavirus 2019 | Malattia da coronavirus 2019 (COVID-19) | Infezione da covid-19 | Infezioni del tratto respiratorio superiore | Infezione del tratto respiratorio | COVID-19 (Coronavirus 2019) | Infezione da COVID-19...Belgio
-
Lawson Research Institute of St. Joseph'sCanadian Institutes of Health Research (CIHR); Western University, CanadaReclutamentoFatica | Sindrome post-COVID-19 | Condizione post COVID-19 | Sindrome post-COVID | Lungo COVID-19 | Lungo-COVID | Condizione post-COVIDCanada
-
ModeX Therapeutics, An OPKO Health CompanyReclutamentoCOVID 19 | COVID-19 (Prevenzione)Stati Uniti
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios...CompletatoSequele post acute di COVID-19 | Condizione post COVID-19 | Lungo-COVID | Sindrome cronica da COVID-19Italia
-
Indonesia UniversityReclutamentoSindrome post-COVID-19 | Lungo COVID | Condizione post COVID-19 | Sindrome post-COVID | Lungo COVID-19Indonesia
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNon ancora reclutamentoSindrome post-COVID-19 | Lungo COVID | Lungo Covid19 | Condizione post COVID-19 | Sindrome post-COVID | Condizione post COVID-19, non specificata | Condizione post-COVIDOlanda