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Recovery After Critical Covid-19 Infection (RECOVID)

27 april 2021 uppdaterad av: Johanna Hastbacka, University of Helsinki
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.

Studieöversikt

Status

Anmälan via inbjudan

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Förväntat)

250

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Capital Province Of Finland
      • Helsinki, Capital Province Of Finland, Finland, 00290
        • Helsinki University Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 100 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Patients who are recovering from critical covid-infection and controls that are either patients recovering from a hospital regular ward treated for covid or covid that has not required hospitalisation. Non-covid controls are age and sex-matched persons (matched to ICU treated group of participants) with no covid-19 in history.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Cognitive function 6 months after hospital discharge
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 6 months after hospital discharge
Plasma neurofilament level and its correlation with global score in neuropsychological test battery
6 months after hospital discharge

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Correlation ApoE 4 alleles with disease severity
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 6 months after hospital discharge
Correlation of matrix metalloproteinase 9 (ng/mL) with lung diffusion capacity z-score
6 months after hospital discharge

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 augusti 2020

Primärt slutförande (Förväntat)

25 juli 2024

Avslutad studie (Förväntat)

25 juli 2024

Studieregistreringsdatum

Först inskickad

9 februari 2021

Först inskickad som uppfyllde QC-kriterierna

27 april 2021

Första postat (Faktisk)

29 april 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

29 april 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 april 2021

Senast verifierad

1 april 2021

Mer information

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