Trial document




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  DRKS00023241

Trial Description

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Title

Population Based Cognitive Testing in Subjects with SARS-CoV-2

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Trial Acronym

POPCOV²

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URL of the Trial

https://www.uniklinik-duesseldorf.de/patienten-besucher/klinikeninstitutezentren/klinik-fuer-neurologie/klinische-studien

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

The Corona Virus Disease 2019 (COVID-19) first observed in December 2019 in Wuhan, China, is a virus disease caused by SARS-CoV-2 that primarily affects the respiratory tract. SARS-CoV-2 was declared a pandemic in March 2020.
Although about 80% of the infected only have moderate symptoms, according to current knowledge, in about 20% of the infected an in-patient stay and if necessary, an intensive medical treatment is needed. The hospitalization rate of patients with SARS-CoV-2 infection is approx. 16% (Lagebericht RKI 24.08.20)
The possibility of an involvement of the nervous system was already discussed in some clinical trials.A first retrospective analyses of a cohort from Wuhan, China shows in 36~67% of the patients an affection of the CNS whereas other studies show an affection of the CNS with 25% more frequently then the PNS with 9%.(Mao et al. JAMA Neurol 2020, Helms et al. NEJM 2020)The most common symptoms were confusion and agitation.



It also seems to be relevant, that neurological symptoms appear more often in patients with a severe disease process, then in patients with only mild symptoms (Mao et al. JAMA Neurol 2020).A possible neurotropy for ß-coronaviruses is described. (Li J Med Virol 2020). Animal studies on the SARS- and Middle East Respiratory Syndrome-virus suggest that the peripheral nervous system is initially affected, most often the olfactory nerve , which, via transynaptic transfer, affects the brain stem and the further course also leads to a spread in the central nervous system (Mc Cray J Virol 2007, Netland J Virol 2008, Li J Infect Dis 2016, Li J Med Virol 2020).

At the moment it is hardly known how SARS-CoV-2 is affecting the cognitive functions and how the long-term effects are. (Ritchie et. al Brain Comm. 2020).
Because of the raising numbers of corona cases with CNS-affections, long-terms effects are to become very-likely. This could lead to severe restrictions in daily life and so to drastically reduced quality of life.
So far, all published studies are based on small case-reports, concerning patients in a hospital environment. A change of the mental status was the most reported symptom in these patients. Psychoses, delirium and cognitive impairment have also been reported. ( Patterson et al. Brain 2020; Benussi et al. Neurology 2020) It was also noticeable that younger patients in particular are having cognitive impairments (Varatharaj et al. Lancet Psychiatry 2020).


It is entirely ambiguous , whether these results are affected by the hospitalization or different use of the healthcare system.
Many patients infected with SARS-CoV-2 show only moderate or no symptoms of an airway infection, so there is no need for a treatment in a hospital. It is unclear whether those patients have any clinically relevant cognitive impairments in the acute-phase of the infection or afterwards and if they do, how serious they are.
In this respect it is imperative to test a much bigger population outside the hospital with established and sensitive neuropsychological tests.
Using electronic examinations via video telephony (remote testing), the aim of this study is to characterize the cognitive effects of SARS-CoV-2 more precisely to detect any long-term damage that can lead to impairment of quality of life, especially in young patients, earlier. This data is of high importance for both medical understanding and society. The methods could also be analyzed in respect of prognostic significance.
The aim of this study is to detect possible cognitive impairments in patients with SARS-CoV-2 through neuropsychological tests and compare them with SARS-CoV-2 negative patients.



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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00023241
  •   2020/12/21
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  •   yes
  •   Approved
  •   2020-1198, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
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Secondary IDs

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Health Condition or Problem studied

  •   U07.1 -  Emergency use of U07.1
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Interventions/Observational Groups

  •   Subjects with a positive COVID-19 test.
    We use two neuropsychological tests: The Montreal Cognitive Assessment (MoCA) and the Symbol Digital Modalities Test (SDMT).
    The examinations will be carried according to the following scheme:
    1.Baseline: Within a week after the test result (according to acute phase of COVID-19)
    2. 4-6 weeks after baseline
    3. 12-14 weeks after baseline
    4.Only for COVID-19 positive subjects with pathological findings (MOCA<26 and/or SDMT z-value<-1), during examination 3 :24-26 weeks after baseline
    5. Only for COVID-19 positive subjects with pathological findings(MOCA<26 and/or SDMT z-value<-1), during examination 4: 48-52 weeks after baseline
  •   Subjects with a negative COVID-19 test.
    We use two neuropsychological tests: The Montreal Cognitive Assessment (MoCA) and the Symbol Digital Modalities Test (SDMT).
    The examinations will be carried according to the following scheme:
    1.Baseline: Within a week after the test result (according to acute phase of COVID-19)
    2.4-6 weeks after baseline
    3. 12-14 weeks after baseline
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Prognosis
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

WHAT: Cognitive impairments in subjects with COVID-19
WHEN: Parameters are collected within one week after the test result, 4-6 weeks after the 1st test, 12-14 weeks after the 1st test
In the case of pathological values, two further tests are carried out 24-26 weeks and 48-52 weeks after the 1st test

HOW: The cognitive impairments are measured with the MoCA and the SDMT.

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Secondary Outcome

none

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2020/12/28
  •   2600
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

• Proof of an examination result for SARS-CoV-2 within the last week.
• Understanding of the course of study and consent to study participation
• Subject must be 18 years or older.
• PC, smartphone or tablet must be available.
• Willingness to conduct research on end-to-end encrypted video telephony.

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Exclusion Criteria

<18 years of age

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Düsseldorf-Klinik für Neurologie
    • Mr.  Professor  Philipp  Albrecht 
    • Moorenstraße 5
    • 40225  Düsseldorf
    • Germany
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    • Universitätsklinikum Düsseldorf-Klinik für Neurologie Zentrum für Bewegungsstörungen und Neuromodulation
    • Ms.  Doktor  Saskia  Elben 
    • Moorenstraße 5
    • 40225  Düsseldorf
    • Germany
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    • Universitätsklinikum Düsseldorf-Klinik für Neurologie Zentrum für Bewegungsstörungen und Neuromodulation
    • Ms.  Doktor  Saskia  Elben 
    • Moorenstraße 5
    • 40225  Düsseldorf
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Düsseldorf-Klinik für Neurologie
    • Moorenstraße 5
    • 40225  Düsseldorf
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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