COVID-19NeuroBiomarKNCT05079373
Study of Neurological Damage From Coronavirus Disease (COVID-19)
An observational study of COVID-19, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The objective of this study is to support the exploration of the NEURO-COVID-19 database and in particular to carry out the post-treatments necessary to derive quantitative information on the characterization of the lesion load, in particular with regard to of the vascular tree Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2021to 31 Oct 2022
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Adult patient having covid and presenting with neurological symptoms leading to an MRI.
Who may be able to join
- Adult patient (≥18 years old)
- COVID + patient presenting with neurological symptoms leading to an MRI.
- Patient taken care of in one of the care centers associated with this research
- Patient not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.
Who cannot join
- Patient who expressed his opposition to participating in the study
- COVID patient not having neurological symptoms or not having received an MRI
- Patient under guardianship or guardianship
- Patient under legal protection
Trial locations and contacts
1 site in 1 country.
Saïd CHAYER, PhD, HDR contact
France1 site, 1 recruiting
- Recruiting
Service d'Imagerie 2 - Neuroradiologie et Radiologie Ostéo-articulaire - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Stephane Kremer, MD, PhD, 33 3 88 12 78 89, stephane.kremer@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, said.chayer@chru-strasbourg.fr
About this study
Official title: Study of Neurological Damage From Coronavirus Disease (COVID-19): Extraction of Quantitative Imaging Biomarkers for the Characterization of Pathological Profiles
The objective of this study is to support the exploration of the NEURO-COVID-19 database and in particular to carry out the post-treatments necessary to derive quantitative information on the characterization of the lesion load, in particular with regard to of the vascular tree
- Conditions
- COVID-19
- Keywords
- COVID-19, SARS-COV-2, Central nervous system, Headache, Loss of smell, Coma
- Medical subject headings
- COVID-19, Headache, Anosmia, Coma
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective study of the neurological damage in patients with Covid-19
Measured: Files analysed retrospectively from January 01, 2020 to October 31, 2021 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start1 Apr 2021
- Primary completion9 Oct 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079373
- Sponsor's protocol ID
- 8184
- Acronym
- NeuroBiomarK
- Status last verified
- Oct 2021
- First submitted
- 13 Oct 2021
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Neurological Damage From Coronavirus Disease (COVID-19): Extraction of Quantitative Imaging Biomarkers for the Characterization of Pathological Profiles
- ClinicalTrials.gov ID
- NCT05079373
- Acronym / sponsor ID
- NeuroBiomarK / 8184
- Conditions
- COVID-19
- Keywords
- COVID-19, SARS-COV-2, Central nervous system, Headache, Loss of smell, Coma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 9 Oct 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 15 Oct 2021 (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.
The objective of this study is to support the exploration of the NEURO-COVID-19 database and in particular to carry out the post-treatments necessary to derive quantitative information on the characterization of the lesion load, in particular with regard to of the vascular tree
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patient having covid and presenting with neurological symptoms leading to an MRI.
Key inclusion criteria (4 listed)
- Adult patient (≥18 years old)
- COVID + patient presenting with neurological symptoms leading to an MRI.
- Patient taken care of in one of the care centers associated with this research
- Patient not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.
Key exclusion criteria (4 listed)
- Patient who expressed his opposition to participating in the study
- COVID patient not having neurological symptoms or not having received an MRI
- Patient under guardianship or guardianship
- Patient under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retrospective study of the neurological damage in patients with Covid-19
Time frame: Files analysed retrospectively from January 01, 2020 to October 31, 2021 will be examined]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
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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.
Saïd CHAYER, PhD, HDR contact
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 COVID-19, run by University Hospital, Strasbourg, France at 1 site in France.
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 4 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: status not confirmed, as of the sponsor's last update on 30 Nov 2021. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephane Kremer, MD, PhD (33 3 88 12 78 89, stephane.kremer@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective study of the neurological damage in patients with Covid-19 (time frame: Files analysed retrospectively from January 01, 2020 to October 31, 2021 will be examined]). 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 30 Nov 2021.