Trial document




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  DRKS00025523

Trial Description

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Title

Prospective controlled long-term study to investigate cognitive impairment in patients with previous treatment to intensive care units (ICU), with and without SARS-CoV-2-infection and in mild COVID-19 patients without previous ICU treatment

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Trial Acronym

postCoV-Cog

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URL of the Trial

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Brief Summary in Lay Language

Independent of the course of an acute COVID-19 infection, long-lasting symptoms (e.g. severe, persistent fatigue, problems in concentration and memory, increased anxiety and depressive mood), are described by patients. This described syndrom is also referred to as post-COVID syndrom (if the symptoms persist at least 12 weeks after the acute infection and cannot be explained by other diagnoses). The complaints might cause considerable psychosocial restrictions in everyday life and might lead to a decrease in quality of life.

Available data regarding long-lasting symptoms after COVID-19 infection are currently very limited. A systematic recording and long-term observation of cognitive and emotional parameters in intensive care patients with and without COVID-19 infection as well as in mild, non-hospitalized COVID-19 patients with persistent symptoms should help to better understand different courses of recovery and to better describe persistent symptoms after acute infection in order to clarify the need for aftercare and to promote the development of appropriate aftercare concepts.

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Brief Summary in Scientific Language

Some COVID-19 patients with previous treatment on intensive care units (ICU) suffer from symptoms that are similarily known from patients with „post-intensive-care-syndrom (PICS)“. Cognitive deficits, critical illness polyneuropathy / myopathy (CIP / CIM), post-traumatic stress disorder (PTSD), depression and anxiety disorders are associated with PICS. Cognitive deficits include attentional and memory disorders, and changes in behavior, and primarily affects patients who were ventilated for some time during their ICU stay.
Impairments may occur immediately after the ICU stay or for a longer period afterwards.

Even some patients with mild COVID-19 infection without previous ICU treatment report long-term cognitive deficits and residual fatigue after the acute infection and consult specialized Post-COVID out-patient clinics.

So far, reliable data on cognitive and emotional long-term effects of COVID-19 infection that meet the temporal criteria of a post-COVID syndrome (acute infection occurred more than 12 weeks ago) are missing. In addition, it is unclear how frequently, persistent and pronounced long-term effects are, to what extent complaints interfere with daily life, and whether there may be risk factors that make the development of post-COVID symptoms more likely. Likewise, the distinction from PICS after an ITS stay is unclear.

The aim of this controlled long-term study is to systematically assess clinical outcome of previously treated ICU CIP/CIM patients with or without (primary pulmonary disease) COVID-19 infection and to compare their outcome to the persisting symptoms of patients with mild acute COVID-19 symptoms. The main question is, whether ICU treated patients with and without COVID-infection recover differently and suffer from different cognitive and emotional long-term complains or not, and how the persistent symptoms after mild COVID-19 infection fits into this picture.

For this purpose, cognitive parameters and self-reported outcomes along with medical data (e.g. pre-existing health condition, medication) will be repeatedly assessed during the stay at rehabilitation clinic (patients after ITS stay) as well as at the post-COVID-19 outpatient clinic (at least 12 weeks later after baseline) of the Charité Berlin. Data will be compared to the complaints of patients after mild COVID-19 infection.

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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

  •   DRKS00025523
  •   2021/06/21
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  •   yes
  •   Approved
  •   2021-2073-NIS ff, Ethik-Kommission der Landesärztekammer Brandenburg
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Secondary IDs

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Health Condition or Problem studied

  •   COVID-19
  •   G62 -  Other polyneuropathies
  •   G72 -  Other myopathies
  •   U07.1 -  Emergency use of U07.1
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Interventions/Observational Groups

  •   patients with COVID-19 infection and previous treatment at ICU
  •   patients (CIP/CIM) without COVID-19 infection and previous treatment at ICU
  •   Non-hospitalized patients after mild COVID-19 infection and persistend deficits
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Cognitive performance in relevant domains:
- Attention (TAP)
- Executive function (TAP, word fluency)
- Working memory (repeating numbers)
- verbal memory (VLMT)
will be assessed several times during hospital (rehabilitation clinic) stay (ITS patients) and at least 12 weeks after acute infection (ITS patients, patients after mild course)

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Secondary Outcome

- global cognition (MoCA)
- Patient reported outcome measures (quality of life, sleep qualilty, anxiety depression, fatigue)
- further cognitive tests
- optional: cMRT anatomical and functional sequences, DTI
(collaboration with the Prof. Finke and BCAN, Charité Berlin)
- Lumbar puncture if clinially indicated (e.g. encephalopathic syndrom, Delir, unclear persistent (subjective) cognitive deficits); analysis of specific antibodies (collaboration with Prof. Prüß, Charité Berlin)
- medical data like length of stay in hospital, duration of ventialtion, complication during inpatient stay, medication, therapies, labor parameters, neurological scores, care level)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2021/06/04
  •   90
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

- Age: 18-90
- Written informed consent

COVID-19 groups:
-COVID-19 infection confirmed by PCR test
-COVID-ITS group:
COVID-19 associated rehabilitation diagnosis (CIP/CIM) and ITS duration >= 1 week
-mild infection: no treatment in hospital; quarantine at home; acute infection >= 12 weeks

Non-COVID-19 group
CIP/CIM rehabilitation diagnosis and ITS duration >= 1 week (primary pulmonar disease or other non cerebral cause)

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Exclusion Criteria

Patients with
-Condition after cardiopulmonary resuscitation (COR)
-acute as well as pre-existing structural brain damage
-pre-existing dementia or other neurodegenerative disease
-severe hepatic insufficiency (hepatic encephalopathy)
-CIP/CIM control patients: proven COVID-19 infection

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Addresses

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    • Neurologische Fachkliniken Beelitz
    • Ms.  Dr.med.  Anna  Gorsler 
    • Paracelsusring 6a
    • 14547  Beelitz-Heilstätten.de
    • Germany
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    • Charité - Universitätsmedizin Berlin Klinik für Neurologie mit Experimenteller Neurologie
    • Mr.  Prof. Dr. med.  Harald  Prüß 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin Klinik für Neurologie mit Experimenteller Neurologie
    • Mr.  Prof. Dr. med.  Carsten  Finke 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin Klinik für Neurologie mit Experimenteller Neurologie
    • Ms.  Dr.med.  Christiana  Franke 
    • Hindenburgdamm 30
    • 12200  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin Klinik für Neurologie mit Experimenteller Neurologie
    • Ms.  Dr.med.  Christiana  Franke 
    • Hindenburgdamm 30
    • 12200  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Recura Kliniken, Medizinischer Beirat
    • Paracelsusring 6a
    • 14547  Beelitz-Heilstätten
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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