Biomarker Analysis in Post-COVID Patients

Sponsor

University Hospital, Bonn (Other)

Overall Status

Completed

CT.gov ID

NCT05836428

Collaborator

(none)

Enrollment

Location

32.8

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Headache is one of the most common neurological manifestations of COVID-19. However, it is unclear whether chronic headache after the initial diagnosis, is associated with ongoing damage of the central nervous system. We investigate cpost-COVID-19 patients with persistent headache lasting longer than 3 weeks, to hospitalized acute COVID-19 patients with neurological symptoms and to other non-COVID-19 disease-controls. Readout are neurologial and glial biomarkers in CSF.

Condition or Disease	Intervention/Treatment	Phase
Post-COVID-19 Syndrome	Other: no intervention

Detailed Description

Measurements of neuronal and glial markers in CSF were performed on a SIMOA analyzer (Quanterix) using the Neurology 4-Plex A (Nf-L, Tau, GFAP, UCH-L1) kit.

Study Design

Study Type:

Observational

Actual Enrollment :

48 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

Biomarker Analysis in COVID and Post-COVID Patients

Actual Study Start Date :

Aug 1, 2020

Actual Primary Completion Date :

Apr 26, 2023

Actual Study Completion Date :

Apr 26, 2023

Arms and Interventions

Arm	Intervention/Treatment
Persistent post-COVID-19 headache post-COVID-19 patients with persistent headache	Other: no intervention no intervention
controls Mild Neuro-COVID-19 patients without persistent headache and other neurological diseases	Other: no intervention no intervention

Arm

Intervention/Treatment

Persistent post-COVID-19 headache

post-COVID-19 patients with persistent headache

Other: no intervention

no intervention

controls

Mild Neuro-COVID-19 patients without persistent headache and other neurological diseases

Other: no intervention

no intervention

Outcome Measures

Primary Outcome Measures

Biomarker analysis in CSF [after 3 months of initial infection]
Levels of Nf-L, Tau, GFAP, UCH-L1 in CSF

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Diagnosis of COVID, Parkinson's disease, primary headache, Multiples Sclerosis, facial paralysis
Persistent post-COVID-19 headache after 3 months of infection
Post COVID-patients without persistent headache
must be able to perform lumbar puncture

Exclusion criteria

unknown history of COVID infection
lumbar puncture not possible

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Laura de Boni	Bonn		Germany	53105

Sponsors and Collaborators

University Hospital, Bonn

Investigators

Principal Investigator: Laura de Boni, MD, DLR German Aerospace Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Laura de Boni, Principal investigator, University Hospital, Bonn

ClinicalTrials.gov Identifier:

NCT05836428

Other Study ID Numbers:

First Posted:

May 1, 2023

Last Update Posted:

May 1, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Laura de Boni, Principal investigator, University Hospital, Bonn

persistent headache

Study Results

No Results Posted as of May 1, 2023