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

Conditions: COVID-19
G62
G72
U07.1
Other polyneuropathies
Other myopathies
COVID-19, virus identified

Registration Number: DRKS00025523

Lead Sponsor: eurologische Fachkliniken Beelitz

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting stopped after recruiting started

Sex: All

Target Recruitment: 64

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)

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

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognitive performance in relevant domains:<br>- Attention (TAP)<br>- Executive function (TAP, word fluency)<br>- Working memory (repeating numbers)<br>- verbal memory (VLMT)<br>will be assessed several times during hospital (rehabilitation clinic) stay (ITS patients)<br> at least 12 weeks after acute infection (ITS patients, patients after mild course) a follow-up measurement will be performed

Secondary Outcome Measures

Name	Time	Method
a) global cognition (MoCA)<br>b) Patient reported outcome measures (quality of life, sleep qualilty, anxiety depression, fatigue)<br>c) further cognitive tests<br>d) optional: cMRT anatomical and functional sequences, DTI<br>(collaboration with the Prof. Finke and BCAN, Charité Berlin)<br>e) 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) <br>f) medical data like length of stay in hospital, duration of ventialtion, complication during inpatient stay, medication, therapies, labor parameters, neurological scores, care level)<br>g) optional: resting state EEG during the long-term follow-up visit to measure neuronal EEG correlates (frequency and coherence parameters)