SARS-CoV-2 InfectionNeuroCovidNCT04643548
WHO Covid 19 - Neurological Abnormalities in SARS-CoV-2 ICU Patients
An observational study of SARS-CoV-2 Infection and Intensive Care Unit Patient, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The SARS-CoV-2 epidemic is leading to a large number of patients in intensive care units due to severe hypoxemic pneumonia. After an acute phase that may require controlled mechanical ventilation and deep sedation, removal of sedation often reveals a pathological awakening in the vast majority of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV-2 Infection, Intensive Care Unit Patient, Neurological Abnormality
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 13 Oct 2020to 13 Aug 2021
- 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: Patients hospitalized in Intensive Care Unit and infected bye SARS-CoV-2
Who may be able to join
- Age ≥ 18 years old
- COVID-19 positive patient (positive RT PCR, nasopharyngeal or tracheal)
- Patient admitted in an intensive care unit of the department of Anesthesia, Critical Care and Perioperative of Clermont-Ferrand University Hospital
- Patient with an arterial or central catheter to perform blood samples collection
Who cannot join
- Patient or family member's refusal to participate
- Neuropsychiatric history that may interfere with neurological evaluations in the intensive care unit
- Patient not affiliated with French social security insurance
- Patient under legal guardianship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU
Clermont-Ferrand, 63000
Thomas Godet, tgodet@chu-clermontferrand.fr
Benjamin Rieu, brieu@chu-clermontferrand.fr
About this study
Official title: Neurological Abnormalities in SARS-CoV-2 ICU Patients. A Prospective Study. NeuroCOVID Study
The SARS-CoV-2 epidemic is leading to a large number of patients in intensive care units due to severe hypoxemic pneumonia. After an acute phase that may require controlled mechanical ventilation and deep sedation, removal of sedation often reveals a pathological awakening in the vast majority of patients. This encephalopathy state remains, to date and to our knowledge, unexplained. Clinical features do not appear to fully correlate with regular delirium. This encephalopathy might be explained by deep and prolonged hypoxemia, a wide use of sedation drugs, systemic inflammation or the hostile ICU environment.
Read the detailed description
This study is intended to investigate neurological abnormalities associated with SARS-CoV-2 infection. Complete daily neurological examinations will be routinely conducted in intensive care unit patients. Specific biological analyses will also be performed in these patients by collecting additional blood samples from an arterial or central catheter, every 2 days. These clinical and biological examinations will be continued throughout patient's stay in the intensive care unit.
- Conditions
- SARS-CoV-2 Infection, Intensive Care Unit Patient, Neurological Abnormality, Delirium, Encephalopathy
- Keywords
- SARS-CoV-2 infection, Intensive care unit patient, Neurological abnormalities, Delirium, Encephalopathy
- Medical subject headings
- COVID-19, Nervous System Malformations, Delirium, Brain Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosage of biomarkers typically explored in intensive care unit delirium
Plasminogen activator inhibitor-1 (PAI-1), E-selectin and angiopoietin-2
Measured: Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every 2 days
Dosage of neuronal injury markers
S100 β, Neuron Specific Enolase (NSE), GFAP, UCHL1, NFL
Measured: Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every 2 days
Secondary outcomes (8)
Delirium assessment
CAM-ICU (Confusion Assessment Method - Intensive Care Unit) scale
Measured: Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
Delirium assessment
ICDSC (Intensive Care Delirium Screening Checklist) scale.
Measured: Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
Coma assessment
CRS-R (Coma Recovery Scale-Revised)
Measured: Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
Pupils characteristics
Clinical observation
Measured: Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
Pupils characteristics
Pupilometer assessment
Measured: Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
Neurological abnormalities
Electroencephalogram : epileptic activity (spikes, spike-waves) or encephalopathy activity (triphasic waves))
Measured: Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
Neurological abnormalities
CT-scan
Measured: Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
Neurological abnormalities
MRI
Measured: Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start13 Oct 2020
- Primary completion13 Jun 2021 (estimated)
- Study completion13 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643548
- Sponsor's protocol ID
- NeuroCovid-RNI 2020 GODET
- Acronym
- NeuroCovid
- Status last verified
- Nov 2020
- First submitted
- 16 Nov 2020
- Last updated
- 1 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurological Abnormalities in SARS-CoV-2 ICU Patients. A Prospective Study. NeuroCOVID Study
- ClinicalTrials.gov ID
- NCT04643548
- Acronym / sponsor ID
- NeuroCovid / NeuroCovid-RNI 2020 GODET
- Conditions
- SARS-CoV-2 Infection, Intensive Care Unit Patient, Neurological Abnormality, Delirium, Encephalopathy
- Keywords
- SARS-CoV-2 infection, Intensive care unit patient, Neurological abnormalities, Delirium, Encephalopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 13 Jun 2021 (estimated)
- Study completion
- 13 Aug 2021 (estimated)
- First posted
- 25 Nov 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.
The SARS-CoV-2 epidemic is leading to a large number of patients in intensive care units due to severe hypoxemic pneumonia. After an acute phase that may require controlled mechanical ventilation and deep sedation, removal of sedation often reveals a pathological awakening in the vast majority of patients. This encephalopathy state remains, to date and to our knowledge, unexplained. Clinical features do not appear to fully correlate with regular delirium. This encephalopathy might be explained by deep and prolonged hypoxemia, a wide use of sedation drugs, systemic inflammation or the hostile ICU environment.
Detailed description
This study is intended to investigate neurological abnormalities associated with SARS-CoV-2 infection. Complete daily neurological examinations will be routinely conducted in intensive care unit patients. Specific biological analyses will also be performed in these patients by collecting additional blood samples from an arterial or central catheter, every 2 days. These clinical and biological examinations will be continued throughout patient's stay in the intensive care unit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in Intensive Care Unit and infected bye SARS-CoV-2
Key inclusion criteria (4 listed)
- Age ≥ 18 years old
- COVID-19 positive patient (positive RT PCR, nasopharyngeal or tracheal)
- Patient admitted in an intensive care unit of the department of Anesthesia, Critical Care and Perioperative of Clermont-Ferrand University Hospital
- Patient with an arterial or central catheter to perform blood samples collection
Key exclusion criteria (4 listed)
- Patient or family member's refusal to participate
- Neuropsychiatric history that may interfere with neurological evaluations in the intensive care unit
- Patient not affiliated with French social security insurance
- Patient under legal guardianship
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
Dosage of biomarkers typically explored in intensive care unit delirium
Time frame: Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every 2 days
Plasminogen activator inhibitor-1 (PAI-1), E-selectin and angiopoietin-2
Dosage of neuronal injury markers
Time frame: Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every 2 days
S100 β, Neuron Specific Enolase (NSE), GFAP, UCHL1, NFL
8 secondary outcomes
Delirium assessment
Time frame: Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
Delirium assessment
Time frame: Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
Coma assessment
Time frame: Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
Pupils characteristics
Time frame: Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
Pupils characteristics
Time frame: Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
Neurological abnormalities
Time frame: Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
Neurological abnormalities
Time frame: Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
Neurological abnormalities
Time frame: Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
- Individual participant dataSharing planned: Undecided
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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.
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 SARS-CoV-2 Infection and Intensive Care Unit Patient, run by University Hospital, Clermont-Ferrand 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 1 Dec 2020. 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 Lise Laclautre (+33 4 754 963, llaclautre_perrier@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosage of biomarkers typically explored in intensive care unit delirium (time frame: Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every 2 days). The study lists 2 primary outcomes in all. 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 Dec 2020.