NCT05836428

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
Last Updated

May 1, 2023

Status Verified

April 1, 2023

Enrollment Period

2.7 years

First QC Date

April 26, 2023

Last Update Submit

April 28, 2023

Conditions

Post-COVID-19 Syndrome

Keywords

persistent headache

Outcome Measures

Primary Outcomes (1)

  • Biomarker analysis in CSF

    Levels of Nf-L, Tau, GFAP, UCH-L1 in CSF

    after 3 months of initial infection

Study Arms (2)

Persistent post-COVID-19 headache

post-COVID-19 patients with persistent headache

Other: no intervention

controls

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

Other: no intervention

Interventions

no interventionOTHER

no intervention

Persistent post-COVID-19 headachecontrols

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

General population

You may qualify if:

  • 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

You may not qualify if:

  • unknown history of COVID infection
  • lumbar puncture not possible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laura de Boni

Bonn, 53105, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

CSF

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Laura de Boni, MD

    DLR German Aerospace Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 26, 2023

First Posted

May 1, 2023

Study Start

August 1, 2020

Primary Completion

April 26, 2023

Study Completion

April 26, 2023

Last Updated

May 1, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)