- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05025839
Neurological Outcome After SARS-CoV-2 Infection (ATTRACT)
Long-term Neurological Outcome After SARS-CoV-2 Infection
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
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Tyrol
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Innsbruck, Tyrol, Østrig, 6020
- Rekruttering
- Medical University Innsbruck, Department of Neurology
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Kontakt:
- Raimund Helbok, Priv.Doz. Dr.
- Telefonnummer: 81689 +43 50 504
- E-mail: raimund.helbok@tirol-kliniken.at
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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:
- (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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Case-Control
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
C healthy
Healthy control group
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No Intervention takes place, Patients are being observed and classified according to disease severity
Andre navne:
|
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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
Andre navne:
|
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Mild
Outpatients presenting to the hospital with COVID-19
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No Intervention takes place, Patients are being observed and classified according to disease severity
Andre navne:
|
|
Moderate
In-patients with COVID-19 not requiring ICU admission
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No Intervention takes place, Patients are being observed and classified according to disease severity
Andre navne:
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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
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Prevalence of neurological manifestations in COVID-19 patients
Tidsramme: 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
|
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Prevalence of neurological manifestations in COVID-19 patients
Tidsramme: 12-months
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12-month prevalence of neurological manifestations in COVID-19 patients presenting to the hospital in comparison to control patients (Cpneum)
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12-months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Association, prevalence and classification of neurologic manifestations with structural neuroimaging in hospitalised COVID-19 patients after 3-months.
Tidsramme: 3-months
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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.
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3-months
|
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Association, prevalence and classification of neurologic manifestations with structural neuroimaging in hospitalised COVID-19 patients after 12-months.
Tidsramme: 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.
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12-months
|
Samarbejdspartnere og efterforskere
Sponsor
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
- KLI 986
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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