Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Neurological Outcome After SARS-CoV-2 Infection (ATTRACT)

23 agosto 2021 aggiornato da: Medical University Innsbruck

Long-term Neurological Outcome After SARS-CoV-2 Infection

Wider research context: Since the recognition of SARS-CoV-2 outbreak in 2019, there are now over 126 million COVID-19 cases worldwide with more than 2.7 million deaths. Reports on neurological manifestations vary in prevalence rates (6-84%) and range from mild (headache, hyposmia, myalgia) to severe (encephalopathy, strokes, seizures). Little is known about long-term neurological outcomes of COVID-19 patients. The investigators propose a structured protocol to capture persistent and delayed neurological manifestations, neurocognitive deficits and quality of life (QoL) 3 and 12 months after COVID-19. Objectives: The investigators hypothesize that neurological manifestations and neuropsychological/cognitive deficits can be detected after COVID-19, substantially impact on patients' QoL and can be correlated with structural neuroimaging findings. Main objectives are to assess firstly long-term prevalence rates and natural history of neurological manifestations, secondly neuropsychological/cognitive deficits after COVID-19, thirdly the impact of COVID-19 on measures of mental health, QoL and functional outcome, fourthly to correlate neurological manifestations and distinct neurocognitive deficits with structural MRI abnormalities, and Fifthly to compare these results to age- and sex matched controls hospitalized with pneumonia (Cpneum) and to healthy controls for MRI-data (Chealthy). Approach: The investigators aim to enrol at least 225 patients with COVID-19, in addition to 50 Cpneum and 80 Chealthy. COVID-19 patients will include (group Oóne) outpatients presenting to the hospital, (group two) in-patients not requiring ICU admission, and (group three) patients admitted to the ICU. The investigators will not include asymptomatic patients, patients not presenting to the hospital, and those who do not consent to participate. The standardized protocol includes a firstly a structured neurological examination, secondly olfactory testing, thirdly assessment of QoL, mental health and functional outcome at 3 and 12 months, and fourthly screening for cognitive deficits (at 3 months) and a structured neuropsychological testing (at 12 months) in COVID-19 patients and controls. In a subset of at least 120 COVID-19 patients and 50 controls (Cpneum) high field MRI will be performed at 3 and 12 months. Innovation: The investigators aim to quantify COVID-19 related and specific neurological manifestations and their impact on the individual health condition. The novelty lies in the prospective design, the longitudinal follow-up including and the inclusion of a control group which allows us to explore the natural history of COVID-19 related neurological manifestations. Preliminary analysis of our ongoing 3-month follow-up suggests persistent neurological manifestations and a significant impact of COVID-19 on mental health, cognition and QoL. The investigators believe that our study results likely influence the long-term care of COVID-19 patients and help to identify those, who need further neuro-rehabilitative support

Panoramica dello studio

Stato

Reclutamento

Intervento / Trattamento

Tipo di studio

Osservativo

Iscrizione (Anticipato)

355

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Reclutamento
        • Medical University Innsbruck, Department of Neurology
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 130 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione di probabilità

Popolazione di studio

We aim to include a full dataset of at least 180 patients undergoing 3- and 12-month follow-up. Due to an estimated dropout rate of ~20%, approximately 225 patients are planned to be included in 3-month follow-up. Out of these, we estimate to include a minimum of 50 patients in each of the 3 pre-defined groups, which is feasible based on the preliminary analysis of patient distribution: severe patients: 25%, moderate patients: 50% and mild patients: 25%. In addition, we aim to include at least 120 patients in the MRI sub-study. For the control group, we plan to include 50 age- and sex matched patients (n=25 normal ward, n=25 ICU admission) who undergo the same 3- and 12-month study protocol including MR imaging and neurocognitive testing as COVID-19 patients. Out of these, we expect an estimated dropout rate of ~10% at the 12-month follow-up resulting in 40 patients who will completely finish the study protocol.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: Caso di controllo
  • Prospettive temporali: Prospettiva

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
C healthy
Healthy control group
No Intervention takes place, Patients are being observed and classified according to disease severity
Altri nomi:
  • Osservazione
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
Altri nomi:
  • Osservazione
Mild
Outpatients presenting to the hospital with COVID-19
No Intervention takes place, Patients are being observed and classified according to disease severity
Altri nomi:
  • Osservazione
Moderate
In-patients with COVID-19 not requiring ICU admission
No Intervention takes place, Patients are being observed and classified according to disease severity
Altri nomi:
  • Osservazione
Severe
Patients with COVID-19 admitted to the ICU
No Intervention takes place, Patients are being observed and classified according to disease severity
Altri nomi:
  • Osservazione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Prevalence of neurological manifestations in COVID-19 patients
Lasso di tempo: 3-months
3-month prevalence of neurological manifestations in COVID-19 patients presenting to the hospital in comparison to control patients (Cpneum)
3-months
Prevalence of neurological manifestations in COVID-19 patients
Lasso di tempo: 12-months
12-month prevalence of neurological manifestations in COVID-19 patients presenting to the hospital in comparison to control patients (Cpneum)
12-months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Association, prevalence and classification of neurologic manifestations with structural neuroimaging in hospitalised COVID-19 patients after 3-months.
Lasso di tempo: 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.
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

7 aprile 2021

Completamento primario (Anticipato)

1 settembre 2023

Completamento dello studio (Anticipato)

1 settembre 2024

Date di iscrizione allo studio

Primo inviato

18 agosto 2021

Primo inviato che soddisfa i criteri di controllo qualità

23 agosto 2021

Primo Inserito (Effettivo)

27 agosto 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

27 agosto 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 agosto 2021

Ultimo verificato

1 agosto 2021

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

No

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

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 SARS-CoV-2

Prove cliniche su No Intervention

Sottoscrivi