- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT05025839
Neurological Outcome After SARS-CoV-2 Infection (ATTRACT)
Long-term Neurological Outcome After SARS-CoV-2 Infection
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
-
-
Tyrol
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Innsbruck, Tyrol, Oostenrijk, 6020
- Werving
- Medical University Innsbruck, Department of Neurology
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Contact:
- Raimund Helbok, Priv.Doz. Dr.
- Telefoonnummer: 81689 +43 50 504
- E-mail: raimund.helbok@tirol-kliniken.at
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-
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:
- (1) Patients of either sex, aged ≥18 years with
- (2) confirmed SARS-CoV-2 infection (according to the Austrian Federal Ministry of Social Affairs, Health, Care and Consumer Protection),
- (3) signed and dated declaration of consent by the patient according to ICH-GCP Guidelines,
- (4) being able to speak and understand the German language
Exclusion Criteria:
- (1) Pre-existing dementia,
- (2) confirmed pregnancy,
- (3) patients without the capacity to consent,
- (4) asymptomatic patients,
- (5) patients not presenting to the hospital
Specific Inclusion/exclusion criteria for the MRI substudy
Inclusion criteria:
- (1) Patients of either sex, aged ≥18 years with
- (2) confirmed SARS-CoV-2 infection (according to the Austrian Federal Ministry of Social Affairs, Health, Care and Consumer Protection),
- (3) signed and dated declaration of consent by the patient according to ICH-GCP Guidelines,
- (4) being able to speak and understand the German language
- (5) agree to participate for MRI
Exclusion criteria:
- (1) Pre-existing dementia,
- (2) confirmed pregnancy,
- (3) patients without the capacity to consent,
- (4) asymptomatic patients,
- (5) patients not presenting to the hospital
- (6) definite contraindication to MRI (e.g. pacemakers)
Controls Patients after pneumonia (Cpneum) We will enrol at least 50 hospitalized age- and sex matched patients with pneumonia based on disease severity during the acute disease as: (group One) hospitalized (moderate; n=25) and (group two) severe patients admitted to the ICU for mechanical ventilation (n=25).
Inclusion criteria:
- (1) Patients of either sex, aged ≥18 years with
- (2) bacterial pneumonia according to CDC criteria,
- (3) signed and dated declaration of consent by the patient according to ICH-GCP Guidelines, and
- (4) being able to speak and understand the German language,
- (5) agree to participate for MRI
Exclusion criteria:
- (1) Pre-existing dementia,
- (2) confirmed pregnancy,
- (3) patients without the capacity to consent,
- (4) definite contraindication to MRI (e.g. pacemakers)
Healthy referents (Chealthy) Currently n=38 MRI acquisitions of prospectively recruited healthy individuals are available, fulfilling the criteria of this proposal (age- and sex matched; same MR protocol). This cohort will be prospectively extended by n=42 to reach age and sex matched criteria.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Case-control
- Tijdsperspectieven: Prospectief
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
C healthy
Healthy control group
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No Intervention takes place, Patients are being observed and classified according to disease severity
Andere namen:
|
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C pneum
Control group of patients who were hospitalised and diagnosed with pneumonia ( COVID-19 pneumonia excluded)
|
No Intervention takes place, Patients are being observed and classified according to disease severity
Andere namen:
|
|
Mild
Outpatients presenting to the hospital with COVID-19
|
No Intervention takes place, Patients are being observed and classified according to disease severity
Andere namen:
|
|
Moderate
In-patients with COVID-19 not requiring ICU admission
|
No Intervention takes place, Patients are being observed and classified according to disease severity
Andere namen:
|
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Severe
Patients with COVID-19 admitted to the ICU
|
No Intervention takes place, Patients are being observed and classified according to disease severity
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Prevalence of neurological manifestations in COVID-19 patients
Tijdsspanne: 3-months
|
3-month prevalence of neurological manifestations in COVID-19 patients presenting to the hospital in comparison to control patients (Cpneum)
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3-months
|
|
Prevalence of neurological manifestations in COVID-19 patients
Tijdsspanne: 12-months
|
12-month prevalence of neurological manifestations in COVID-19 patients presenting to the hospital in comparison to control patients (Cpneum)
|
12-months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Association, prevalence and classification of neurologic manifestations with structural neuroimaging in hospitalised COVID-19 patients after 3-months.
Tijdsspanne: 3-months
|
Association of neurologic manifestations (specifically neuropsychological deficits and smelling deficits) with structural neuroimaging (high-field MRI) in comparison to control patients (Cpneum).
Prevalence and classification of neuroimaging abnormalities in hospitalized COVID-19 patients in comparison to controls (Cpneum and Chealthy).
Other (exploratory) endpoints derived from the clinical database might be analyzed on data driven considerations 3-months after acute disease.
|
3-months
|
|
Association, prevalence and classification of neurologic manifestations with structural neuroimaging in hospitalised COVID-19 patients after 12-months.
Tijdsspanne: 12-months
|
Association of neurologic manifestations (specifically neuropsychological deficits and smelling deficits) with structural neuroimaging (high-field MRI) in comparison to control patients (Cpneum).
Prevalence and classification of neuroimaging abnormalities in hospitalized COVID-19 patients in comparison to controls (Cpneum and Chealthy).
Other (exploratory) endpoints derived from the clinical database might be analyzed on data driven considerations 12-months after acute disease.
|
12-months
|
Medewerkers en onderzoekers
Sponsor
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
- KLI 986
Plan Individuele Deelnemersgegevens (IPD)
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