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Neurological manifestations of Long Covid-19 in Germany - an observational study (NEURO LC-19 DE)

Organizational Data

DRKS-ID:
DRKS00032475
Recruitment Status:
Recruiting planned
Date of registration in DRKS:
2023-09-27
Last update in DRKS:
2023-09-27
Registration type:
Prospective

Acronym/abbreviation of the study

NEURO LC-19 DE

URL of the study

No Entry

Brief summary in lay language

According to current knowledge, about 10-20% of all COVID-19 patients suffer from a post-COVID-19 syndrome. Neurological symptoms in particular are associated with enormous losses in the quality of life of the affected patients and with drastic restrictions in their participation in social and professional life. There is therefore need to collect robust and well phenotyped clinical data on neurological and neuropsychological consequences of COVID-19.

Brief summary in scientific language

About 10-20% of all COVID-19 patients suffer from a post-COVID-19 syndrome. Neurological symptoms in particular are associated with enormous losses in the quality of life of the affected patients and with drastic restrictions in their participation in social and professional life. There is therefore the need to collect robust and well phenotyped clinical data on neurological and neuropsychological neurological and neuropsychiatric consequences of COVID-19.

Health condition or problem studied

Free text:
U09.9! Post-Covid 19 condition: intended for cases in which the association of a current condition classified elsewhere with a previous coronavirus disease should be coded.
ICD10:
U09.9!
Healthy volunteers:
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Interventions, Observational Groups

Arm 1:
Patients who present themselves due to neurological PCS manifestations in the post-COVID-19 outpatient clinic of the Clinic and Polyclinic for Neurology and in the post-COVID network of the Charité as well as in the interdispensary neuro-PCS consultation of the UK Bonn and who would like to participate in the study.

Endpoints

Primary outcome:
- Structured recording of previous illnesses, medication, course of the disease, symptoms and therapy of the patients - Structured recording of self-report questionnaires on symptoms - Clinical-neurological examination - Neuropsychological testing
Secondary outcome:
- In addition, co-recording and analysis of imaging, neurological diagnostics (e.g. EEG and electrophysiology) and biomaterial electrophysiology) and biomaterial (blood and cerebrospinal fluid (in case of clinical clinical indication for CSF puncture)) and evaluation of regarding prognosis, course and morbidity - Additional analysis of the biomaterial

Study Design

Purpose:
Prognosis
Retrospective/prospective:
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Study type:
Non-interventional
Longitudinal/cross-sectional:
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Study type non-interventional:
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Recruitment

Recruitment Status:
Recruiting planned
Reason if recruiting stopped or withdrawn:
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Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center DZNE Bonn - Sektion für Vaskuläre Neurologie, Klinik für Neurologie, Universitätsklinikum Bonn Bonn
  • University medical center DZNE Berlin - Klinik für Neurologie, Charité - Universitätsmedizin Berlin Berlin

Recruitment period and number of participants

Planned study start date:
2023-12-31
Actual study start date:
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Planned study completion date:
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Actual Study Completion Date:
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Target Sample Size:
700
Final Sample Size:
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Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
- PCS according to NICE guidelines. - Confirmation of initial acute infection by positive SARS-CoV-2- PCR result or serological detection of SARS-CoV-2 nucleocapsid nucleocapsid antibodies - Leading cognitive deficits in the context of PCS

Exclusion Criteria

- Acute COVID-19 disease (<4 weeks). - Absence of confirmation of acute infection by PCR or specific serology - Present symptoms more likely to be explained by other other diagnosis - Pregnancy - Breastfeeding - Insufficient knowledge of German - Participation in an AMG study - beinig under care - not being able to give consent

Addresses

Primary Sponsor

Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE)
53127 Bonn
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE)
Prof. Dr. med. Gabor Petzold
Venusberg Campus 1 Gebäude 99
53127 Bonn
Germany
Telephone:
+49 (228) 43302-490
Fax:
No Entry
Contact per E-Mail
URL:
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Contact for Public Queries

Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE)
Prof. Dr. med. Gabor Petzold
Venusberg Campus 1 Gebäude 99
53127 Bonn
Germany
Telephone:
+49 (228) 43302-490
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE)
Prof. Dr. med. Gabor Petzold
Venusberg Campus 1 Gebäude 99
53127 Bonn
Germany
Telephone:
+49 (228) 43302-490
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE) e.V.
53127 Bonn
Germany
Telephone:
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Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Institutional budget, no external funding (budget of sponsor/PI)

Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE) e.V.
53127 Bonn
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethik-Kommission Medizinische Fakultät Bonn
Venusberg Campus 1
53127 Bonn
Germany
Telephone:
+49-228-28751562
Fax:
No Entry
Contact per E-Mail
URL:
http://ethik.meb.uni-bonn.de

Vote of leading Ethics Committee

Date of ethics committee application:
2023-03-06
Ethics committee number:
081/23-EP
Vote of the Ethics Committee:
No approval required according to the EC
Date of the vote:
2023-03-09

Further identification numbers

Other primary registry ID:
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EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
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IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
Yes
IPD Sharing Plan:
The transfer of biomaterial and data to third parties is regulated by cooperation agreements and takes place exclusively in pseudonymized form. The participant code will not be transmitted in any case. This includes the investigation in a joint project funded by the EU Commission funded collaborative project (NeuroCOV) on COVID-19 with partners in Milan in Milan (University of Milan & Human Technopole), Munich (HMGU), Amsterdam (VUMC), Umea (University of Umea), Helsinki (University of Helsinki), Be'er Sheva (Ben-Gurion University). The data is only stored on servers with security standards similar to those in as in Europe. The transfer of the DNA/RNA isolated from the blood or DNA/RNA isolated from the blood or swab samples or data to third parties including the publication of the results in scientific journals scientific journals will only take place within the framework of this project and exclusively in pseudonymized form - i.e. without names or identifying personal data. If necessary, the study-related data in exclusively pseudonymized form to service providers pseudonymized form to service providers (statisticians) for the purpose of study-related data analysis. The study results are published in an anonymous form that does not allow any which do not allow any inference to the participating person. will be published. In the case of some scientific journals, the data records can be deposited in pseudonymous form for this purpose.

Study protocol and other study documents

Study protocols:
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Study abstract:
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Other study documents:
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Background literature:
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Related DRKS studies:
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Publication of study results

Planned publication:
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Publikationen/Studienergebnisse:
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Date of first publication of study results:
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DRKS entry published for the first time with results:
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Basic reporting

Basic Reporting / Results tables:
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Brief summary of results:
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