Critical IllnessNCoVNCT04359914
Neurocognitive Impairment in Patients With COVID-19
An observational study of Critical Illness and COVID-19, run by University of Rostock at 1 site in Germany.
Trial summary
Delirium and acute neurocognitive impairment are increasingly observed in adult and pediatric patients with COVID-19. Prospective clinical studies combining clinical and laboratory examinations including specific biomarkers of neuroaxonal injury were not performed for COVID-19. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Critical Illness, COVID-19, Central Nervous System Injury
- How many people
- 118 participants
- Where
- 1 siteGermany
- Study dates
- 15 Apr 2020to 31 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with suspected SARS-CoV-2 infection who are admitted to the study centers will be screened for study eligibility according to the inclusion and exclusion criteria.
Who may be able to join
- adult patients of every age
- admission to hospital with suspected COVID-19 disease
- confirmed SARS-CoV-2 infection within 48 hours after admission
Who cannot join
- transferral from another hospital
- other acute central nervous system diseases (e.g. meningoencephalitis, intracerebral ischemia or hemorrhage)
- confirmed SARS-CoV-2 infection later than 48 hours after hospital admission
- participation in another interventional study
- no written informed consent from patient or legal representative
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine, University Medical Center Rostock
Rostock, Mecklenburg-Vorpommern, D-18057
About this study
Official title: Biomarker-guided Assessment of Neurocognitive Impairment in Patients With COVID-19 - a Multicenter Case-control Study
Delirium and acute neurocognitive impairment are increasingly observed in adult and pediatric patients with COVID-19. Prospective clinical studies combining clinical and laboratory examinations including specific biomarkers of neuroaxonal injury were not performed for COVID-19. The value of biomarkers of neuroaxonal injury was proven in preliminary studies. These biomarkers could thus contribute to the systematic detection of neurocognitive impairment in patients with COVID-19. Due to worldwide increasing numbers of hospitalized patients with COVID-19, biomarkers of neuroaxonal injury are highly valuable to detect and monitor cognitive impairment, especially with regard to limited resources available to perform time-consuming brain imaging.
Biomarkers of neuroaxonal injury are therefore not only of great interest to detect neurocognitive impairment but also to quantify the severity of brain injury in patients with COVID-19.
Read the detailed description
This is a multicenter observational study evaluating the incidence and severity of neurocognitive impairment in adult and pediatric patients with COVID-19. All study participants will be assessed by clinical and neurological examination as well as comprehensive laboratory tests using biomarkers of neuroaxonal injury at study day 1 (day of study inclusion), day 3, day 7 and day of hospital discharge. A panel of biomarkers (among others NSE, S100B and neurofilament proteins) will be measured. Clinical assessment will be performed using validated delirium tests (among others CAM-ICU, ICDSC) and scales to assess the neurocognitive performance of study participants before and three months after study inclusion (among others Short Blessed Test).
A group of patients with a comparable severity of disease but without the detection of SARS-Cov-2 will serve as control group and will undergo the same clinical and laboratory examinations.
We hypothesize, that:
- patients with COVID-19 are more likely to develop delirium and neurocognitive impairment than patients without COVID-19
- patients with a preexisting neurocognitive deficit are more vulnerable to neurocognitive impairment in the course of COVID-19 than patients without a preexisting neurocognitive deficit
- Specific biomarkers of neuroaxonal injury correlate with the clinical severity of acute neurocognitive impairment and can predict the 3-month neurocognitive outcome of patients with COVID-19
- Medical subject headings
- Critical Illness, COVID-19, Delirium, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NCoV-A-COVID | * adult patients of every age * admission to hospital with suspected COVID-19 disease * confirmed SARS-CoV-2 infection within 48 hours after admission | |
| NCoV-A-CONTROL | * adult patients of every age * admission to hospital with suspected COVID-19 disease * exclusion of SARS-CoV-2 infection within 48 hours after admission | |
| NCoV-P-COVID | * pediatric patients * admission to hospital with suspected COVID-19 disease * confirmed SARS-CoV-2 infection within 48 hours after admission | |
| NCoV-P-CONTROL | * pediatric patient * admission to hospital with suspected COVID-19 disease * exclusion of SARS-CoV-2 infection within 48 hours after admission |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delirium/neurocognitive impairment in adult and pediatric patients with COVID-19 compared to patients without COVID-19
Assessment of neurocognitive impairment using validated tools
Measured: Day 90
Change in neuroaxonal injury biomarker levels in patients with COVID-19 compared to patients without COVID-19
Measurement of biomarker levels (e.g. NSE, S100B, neurofilament proteins) derived from blood samples
Measured: Change from baseline biomarker levels at day 28
Neurocognitive 3-months outcome in patients with COVID-19 compared to patients without COVID-19
Assessment of the neurocognitive performance of patients using validated tests (e.g. Short Blessed Test)
Measured: Day 90
Neurocognitive 3-months outcome in patients with COVID-19 compared to patients without COVID-19
Assessment of the change in the neurocognitive performance of patients using validated tests (e.g. IQCODE)
Measured: Change from baseline IQCODE results at day 90
Secondary outcomes (3)
Quality of life in patients with COVID-19 compared to patients without COVID-19 after hospital discharge
Assessment of the overall quality of life using validated tests [e.g. Modified Rankin Scale with a range from 0 (no symptoms) to 6 (dead)]
Measured: Day 90
Length of hospital stay in patients with COVID-19 compared to patients without COVID-19
Cumulative days in hospital
Measured: 1 year
90-day survival in patients with COVID-19 compared to patients without COVID-19
Survival after 90 days
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start15 Apr 2020
- Primary completion31 Mar 2021
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies 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
- Prospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich, University College, London
- Responsible party
- Principal investigator, Dr. Johannes Ehler, MD, University of Rostock
- Investigators
- Johannes Ehler, MD, Principal investigator, University of Rostock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359914
- Sponsor's protocol ID
- COVID-BRAIN
- Acronym
- NCoV
- Status last verified
- Jan 2024
- First submitted
- 19 Apr 2020
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ehler J, Klawitter F, von Mollendorff F, Zacharias M, Fischer DC, Danckert L, Bajorat R, Hackenberg J, Bertsche A, Loebermann M, Geerdes-Fenge H, Fleischmann R, Klinkmann G, Schramm P, Schober S, Petzold A, Perneczky R, Saller T. No substantial neurocognitive impact of COVID-19 across ages and disease severity: a multicenter biomarker study of SARS-CoV-2 positive and negative adult and pediatric patients with acute respiratory tract infections. Infection. 2025 Apr;53(2):593-605. doi: 10.1007/s15010-024-02406-7. Epub 2024 Oct 1.
PubMed 39352661
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker-guided Assessment of Neurocognitive Impairment in Patients With COVID-19 - a Multicenter Case-control Study
- ClinicalTrials.gov ID
- NCT04359914
- Acronym / sponsor ID
- NCoV / COVID-BRAIN
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich, University College, London
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 24 Apr 2020 (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.
Delirium and acute neurocognitive impairment are increasingly observed in adult and pediatric patients with COVID-19. Prospective clinical studies combining clinical and laboratory examinations including specific biomarkers of neuroaxonal injury were not performed for COVID-19. The value of biomarkers of neuroaxonal injury was proven in preliminary studies. These biomarkers could thus contribute to the systematic detection of neurocognitive impairment in patients with COVID-19. Due to worldwide increasing numbers of hospitalized patients with COVID-19, biomarkers of neuroaxonal injury are highly valuable to detect and monitor cognitive impairment, especially with regard to limited resources available to perform time-consuming brain imaging.
Biomarkers of neuroaxonal injury are therefore not only of great interest to detect neurocognitive impairment but also to quantify the severity of brain injury in patients with COVID-19.
Detailed description
This is a multicenter observational study evaluating the incidence and severity of neurocognitive impairment in adult and pediatric patients with COVID-19. All study participants will be assessed by clinical and neurological examination as well as comprehensive laboratory tests using biomarkers of neuroaxonal injury at study day 1 (day of study inclusion), day 3, day 7 and day of hospital discharge. A panel of biomarkers (among others NSE, S100B and neurofilament proteins) will be measured. Clinical assessment will be performed using validated delirium tests (among others CAM-ICU, ICDSC) and scales to assess the neurocognitive performance of study participants before and three months after study inclusion (among others Short Blessed Test).
A group of patients with a comparable severity of disease but without the detection of SARS-Cov-2 will serve as control group and will undergo the same clinical and laboratory examinations.
We hypothesize, that:
- patients with COVID-19 are more likely to develop delirium and neurocognitive impairment than patients without COVID-19
- patients with a preexisting neurocognitive deficit are more vulnerable to neurocognitive impairment in the course of COVID-19 than patients without a preexisting neurocognitive deficit
- Specific biomarkers of neuroaxonal injury correlate with the clinical severity of acute neurocognitive impairment and can predict the 3-month neurocognitive outcome of patients with COVID-19
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NCoV-A-COVID | – | –* adult patients of every age * admission to hospital with suspected COVID-19 disease * confirmed SARS-CoV-2 infection within 48 hours after admission |
| NCoV-A-CONTROL | – | –* adult patients of every age * admission to hospital with suspected COVID-19 disease * exclusion of SARS-CoV-2 infection within 48 hours after admission |
| NCoV-P-COVID | – | –* pediatric patients * admission to hospital with suspected COVID-19 disease * confirmed SARS-CoV-2 infection within 48 hours after admission |
| NCoV-P-CONTROL | – | –* pediatric patient * admission to hospital with suspected COVID-19 disease * exclusion of SARS-CoV-2 infection within 48 hours after admission |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with suspected SARS-CoV-2 infection who are admitted to the study centers will be screened for study eligibility according to the inclusion and exclusion criteria.
Key inclusion criteria (3 listed)
- adult patients of every age
- admission to hospital with suspected COVID-19 disease
- confirmed SARS-CoV-2 infection within 48 hours after admission
Key exclusion criteria (5 listed)
- transferral from another hospital
- other acute central nervous system diseases (e.g. meningoencephalitis, intracerebral ischemia or hemorrhage)
- confirmed SARS-CoV-2 infection later than 48 hours after hospital admission
- participation in another interventional study
- no written informed consent from patient or legal representative
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
Incidence of delirium/neurocognitive impairment in adult and pediatric patients with COVID-19 compared to patients without COVID-19
Time frame: Day 90
Assessment of neurocognitive impairment using validated tools
Change in neuroaxonal injury biomarker levels in patients with COVID-19 compared to patients without COVID-19
Time frame: Change from baseline biomarker levels at day 28
Measurement of biomarker levels (e.g. NSE, S100B, neurofilament proteins) derived from blood samples
Neurocognitive 3-months outcome in patients with COVID-19 compared to patients without COVID-19
Time frame: Day 90
Assessment of the neurocognitive performance of patients using validated tests (e.g. Short Blessed Test)
Neurocognitive 3-months outcome in patients with COVID-19 compared to patients without COVID-19
Time frame: Change from baseline IQCODE results at day 90
Assessment of the change in the neurocognitive performance of patients using validated tests (e.g. IQCODE)
3 secondary outcomes
Quality of life in patients with COVID-19 compared to patients without COVID-19 after hospital discharge
Time frame: Day 90
Length of hospital stay in patients with COVID-19 compared to patients without COVID-19
Time frame: 1 year
90-day survival in patients with COVID-19 compared to patients without COVID-19
Time frame: Day 90
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 29 Jan 2024.
- Derived from this study: PubMed 39352661Ehler J, Klawitter F, von Mollendorff F, Zacharias M, Fischer DC, Danckert L, Bajorat R, Hackenberg J, Bertsche A, Loebermann M, Geerdes-Fenge H, Fleischmann R, Klinkmann G, Schramm P, Schober S, Petzold A, Perneczky R, Saller T. No substantial neurocognitive impact of COVID-19 across ages and disease severity: a multicenter biomarker study of SARS-CoV-2 positive and negative adult and pediatric patients with acute respiratory tract infections. Infection. 2025 Apr;53(2):593-605. doi: 10.1007/s15010-024-02406-7. Epub 2024 Oct 1.
- Individual participant dataSharing planned: No
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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.
Johannes Ehler, MD principal investigator
University of Rostock
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 Critical Illness and COVID-19, run by University of Rostock 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 3 inclusion and 5 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 29 Jan 2024. 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?
Incidence of delirium/neurocognitive impairment in adult and pediatric patients with COVID-19 compared to patients without COVID-19 (time frame: Day 90). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04359914, which also lists 1 linked publication.
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 29 Jan 2024.