- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04377425
COVID-19 Prevalence and Cognitive Deficits in Neurological Patients (Neuro-Covid)
COVID-19 Prevalence, Morbidity and Long Term Cognitive Deficits in Consecutive Patients Presenting With Acute Neurological Symptoms
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is spreading in nearly every country in the world. Patients with coronavirus disease 2019 (COVID-19) typically present with cough, fever and respiratory illness. In another coronavirus (SARS-COV-1) causing the SARS outbreak in 2002 to 2003, neurons have been found to be highly susceptible for infection and the virus can cause extensive neuronal damage with only minimal respiratory affection. Similar to SARS-CoV-1, COVID-19 virus exploits the angiotensin-converting enzyme 2 (ACE-2) receptor to gain entry and infect cells. Both glial and neurons express ACE-2 receptors and makes them potential targets, however the neurotropic potential in humans remain largely undescribed. Neurological manifestations of COVID-19 have only been sporadically described in single or short series of case reports together with a case of COVID-19 RNA in the cerebrospinal fluid.
Loss of smell (anosmia) may be a presenting symptom in COVID-19. Interestingly, in a study from Italy anosmia was present in 19,4% and not typical accompanied by nasal obstruction, rhinitis or sinusitis, making direct damage and invasion of the olfactory nerve more likely. A Chinese study have found that 36.6% of COVID-19 patients experience neurological symptoms and that severely affected COVID-19 patients reported more neurological symptoms.
In general, neurological manifestations to viral disease may occur as a direct result of viral invasion and damage to either the central or peripheral nervous system or from an immune mediated neurological damage either during (para) or after (post) the viral infection. Furthermore, the inflammation in itself can increase the risk of arterial thrombosis and thus ischemic stroke.
Early reports from Italy stresses the need to pay attention to neurological symptoms, as they are often neglected due to the systemic and respiratory impairment. Further, concerning reports from the Center for Disease Control (CDC) in USA, have estimated that out of COVID-19pos patients up to 46.5% may be asymptomatic/pre-symptomatic and 17,5% never develop classical COVID-19 symptoms. The COVID-19 infection is likely to be missed if patients present with symptoms from another organ system. Moreover, it poses a transmission risk for other admitted patients and healthcare workers and a risk that a possible association between e.g. neurological symptoms/diseases and a COVID-19 infection are missed. The role and presence of COVID-19 infection in patients presenting with acute neurological symptoms is currently unknown.
Tipo di studio
Contatti e Sedi
Luoghi di studio
-
-
DK
-
Aalborg, DK, Danimarca, 9000
- Aalborg University Hospital
-
Aarhus, DK, Danimarca, 8200
- Aarhus University Hospital
-
Holstebro, DK, Danimarca, 7500
- Regional Hospital West Jutland, Hostebro
-
Viborg, DK, Danimarca, 8800
- Regional Hospital Central Jutland, Viborg
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Base study: Consecutive patients with acute neurological disease admitted at the Neurology department at Aarhus University Hospital will be tested with a nasopharyngeal swap for SARS-COVID-19 RNA
Extended study: Patients fulfilling the extended study criteria will be asked to participate in extended study depending on their COVID-19 status and whether study criteria are fulfilled
Descrizione
Eligibility criteria for the extended study:
Inclusion Criteria:
- Adult patients
- New onset of neurological symptoms
- Independent in daily activities (modified Rankin Scale ≤ 2)
- Stroke or epilepsy/seizure
Exclusion Criteria:
- Pre-existing neurodegenerative disease
- Diagnosed with cerebral neoplasm
- Pre-existing expected life expectancy < 3 months
- Suspected non-organic (functional) disorder
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
---|---|
Patients with acute neurological symptoms
Consecutive patients with acute neurological disease admitted at the Neurology departments will be tested with a nasopharyngeal swap for SARS-COVID-19 RNA according to standard operating procedures at the department (if estimated hospital stay is >24hours).
Medical and clinical characteristics will be collected
|
COVID-19 swap test PCR performed according to hospital standard operating procedures
|
Stroke patients
COVID-19 positive patients will be asked to participate in the extended study together with matched COVID-19 negative controls. Extended study: Collection of cerebrospinal fluid and blood-samples, clinical and cognitive assessment at baseline and at 3-month follow-up |
COVID-19 swap test PCR performed according to hospital standard operating procedures
|
Seizure/epilepsy
COVID-19 positive patients will be asked to participate in the extended study together with matched COVID-19 negative controls. Extended study: Collection of cerebrospinal fluid and blood-samples, clinical and cognitive assessment at baseline and at 3-month follow-up |
COVID-19 swap test PCR performed according to hospital standard operating procedures
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Prevalence of COVID-19 infection in consecutive patients with neurological symptoms
Lasso di tempo: 6 months
|
To investigate the prevalence of COVID-19 infections in consecutive patients with acute onset of neurological symptoms (with or without prior neurological disease)
|
6 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Three months cognitive function of COVID-19 positive patients
Lasso di tempo: 3 months
|
Three months cognitive function (Montreal Cognitive Assessment) of COVID-19 positive patients compared to COVID-19 negative patients
|
3 months
|
Clinical presentation of neurological symptoms in COVID-19 positive patients
Lasso di tempo: 6 months
|
Characterization of the neurological symptoms in neurological COVID-19 positive patients (exploratory endpoint)
|
6 months
|
Prevalence of pre- and asymptomatic COVID-19 positive patients in acutely admitted neurological patients
Lasso di tempo: 6 months
|
Prevalence of pre-symptomatic and asymptomatic COVID-19pos in acutely admitted patients with a primary complaint of neurological symptoms.
|
6 months
|
Anosmia in COVID-19 positive patients
Lasso di tempo: 6 months
|
Prevalence of anosmia in COVID-19pos patients compared to COVID-19neg patients
|
6 months
|
Exploratory analysis on neuro-specific and inflammatory blood and cerebrospinal fluid markers of COVID-19 infection
Lasso di tempo: 24 months
|
Neuro-specific and inflammatory blood- and cerebrospinal fluid markers in COVID-19 positive patients compared to COVID-19 negative matched controls
|
24 months
|
Exploratory analysis of the coagulation profile of COVID-19 positive patients compared to COVID-19neg patients
Lasso di tempo: 24 months
|
Functional and immunologic plasma assays will be employed to analyze proteins and pathways in coagulation and fibrinolysis
|
24 months
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Grethe Andersen, MD, Aarhus University Hospital
Studiare le date dei record
Studia le date principali
Inizio studio (Anticipato)
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
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Disordini mentali
- Malattia cardiovascolare
- Malattie vascolari
- Disturbi cerebrovascolari
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Infezioni da coronavirus
- Infezioni da Coronaviridae
- Infezioni da Nidovirus
- Infezioni da virus a RNA
- Malattie virali
- Infezioni
- Infezioni delle vie respiratorie
- Malattie delle vie respiratorie
- Polmonite, virale
- Polmonite
- Malattie polmonari
- Manifestazioni neurologiche
- Disturbi neurocognitivi
- Ictus
- Epilessia
- COVID-19
- Malattie del sistema nervoso
- Disfunzione cognitiva
- Convulsioni
- Disturbi cognitivi
Altri numeri di identificazione dello studio
- Neuro-Covid-19
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano 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 Ictus, Acuto
-
Region of Southern DenmarkOdense Municipality, Denmark; Kerteminde Municipality, Denmark; Svendborg Municipality...Completato
-
Peking University Third HospitalShanghai Jiao Tong University School of MedicineAttivo, non reclutante
-
University of Southern DenmarkCompletatoCondizioni mediche acuteDanimarca
-
AstraZenecaCompletatoRiacutizzazioni acute della BPCOCina
-
Central Hospital, Nancy, FranceSconosciutoCondizioni acute in terapia intensivaFrancia
-
Assiut UniversityCompletato
-
Centre Hospitalier Universitaire de NiceCompletato
-
GlaxoSmithKlineCompletato
-
Vanderbilt UniversityTerminatoLesioni polmonari, acuteStati Uniti
-
All India Institute of Medical Sciences, RishikeshSconosciutoLesioni polmonari, acute
Prove cliniche su COVID-19 swap test PCR
-
Duke UniversityNorth Carolina Department of Health and Human ServicesCompletato
-
Assiut UniversityCompletatoCOVID-19 | Chirurgia della catarattaEgitto
-
Cairo UniversityCompletato
-
King's College LondonZoe Global Limited; Department of Health, United KingdomReclutamento
-
Assiut UniversityCompletatoValutare l'esito per i bambini con Covid-19 ricoverati nell'ospedale pediatrico universitario AssuitEgitto
-
BioTeke USA, LLCCSSi Life SciencesCompletato
-
University Hospital, ToulouseCompletato
-
Acibadem UniversityCompletato
-
EDP BiotechParagon Rx Clinical, Inc.; iCura Diagnostics, LLCCompletatoCOVID-19 | Infezione da SARS-CoV-2Stati Uniti
-
MP Biomedicals, LLCEDP BiotechCompletatoCOVID-19 | Infezione da SARS-CoV2Stati Uniti