Post-COVID-19 SyndromeNCT05836428
Biomarker Analysis in Post-COVID Patients
An observational study of Post-COVID-19 Syndrome, run by University Hospital, Bonn at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-COVID-19 Syndrome
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2020to 26 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: General population
Who may be able to join
- 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
Who cannot join
- unknown history of COVID infection
- lumbar puncture not possible
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomarker Analysis in COVID and Post-COVID Patients
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.
Read the 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.
- Conditions
- Post-COVID-19 Syndrome
- Being tested
- no intervention
- Keywords
- persistent headache
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Persistent post-COVID-19 headache | post-COVID-19 patients with persistent headache Receives: Other: no intervention | |
| controls | Mild Neuro-COVID-19 patients without persistent headache and other neurological diseases Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker analysis in CSF
Levels of Nf-L, Tau, GFAP, UCH-L1 in CSF
Measured: after 3 months of initial infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 Aug 2020
- Primary completion26 Apr 2023
- Study completion26 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-COVID-19 SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura de Boni, University Hospital, Bonn
- Investigators
- Laura de Boni, MD, Principal investigator, DLR German Aerospace Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05836428
- Sponsor's protocol ID
- 2
- Status last verified
- Apr 2023
- First submitted
- 26 Apr 2023
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Analysis in COVID and Post-COVID Patients
- ClinicalTrials.gov ID
- NCT05836428
- Acronym / sponsor ID
- 2
- Conditions
- Post-COVID-19 Syndrome
- Keywords
- persistent headache
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 26 Apr 2023 (actual)
- Study completion
- 26 Apr 2023 (actual)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Persistent post-COVID-19 headache | – | Other: no interventionpost-COVID-19 patients with persistent headache |
| controls | – | Other: no interventionMild Neuro-COVID-19 patients without persistent headache and other neurological diseases |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- General population
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- unknown history of COVID infection
- lumbar puncture not possible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | Persistent post-COVID-19 headache, controls |
Primary outcome
Biomarker analysis in CSF
Time frame: after 3 months of initial infection
Levels of Nf-L, Tau, GFAP, UCH-L1 in CSF
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Individual participant dataSharing planned: No
Related trials for Post-COVID-19 Syndrome
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Post-Acute COVID-19 Syndrome
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
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DAOIB for the Treatment of Brain Fog
Long COVID
Active, not recruitingObservational study
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Long COVID
Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura de Boni, MD principal investigator
DLR German Aerospace Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-COVID-19 Syndrome, run by University Hospital, Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarker analysis in CSF (time frame: after 3 months of initial infection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023.