Covid19NS-COVNCT04922905
Nervous System Symptoms Associated With COVID 19
A study testing NEURO + and NEURO - in people with Covid19, run by University Hospital, Toulouse at 1 site in France.
Trial summary
This study aim to prospectively evaluate the neuropsychiatric symptoms of patients infected with the SARS-CoV-2 virus by a standardized neuropsychiatric examination : the global CASE scale (Clinical Assessment Scale in Autoimmune Encephalitis), and the prevalence of disturbances of consciousness, focal neurological… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Covid19
- What is being tested?
- NEURO + and NEURO -
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteFrance
- Study dates
- 2 Apr 2020to 2 Apr 2021
- Phase
- Interventional
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being hospitalized at the Toulouse University Hospital for a COVID-19 infection proven by a probable PCR or COVID-type examination on the chest scan
- Have given oral consent for the collection of clinical neurological data
- Be in a clinical state compatible with a 30-minute neurological examination
- Be French-speaking
- Be affiliated to a Social Security scheme
Who cannot join
- Refusal of the neurological examination
- History of neurological pathology at a severe stage
- Pregnant or breastfeeding woman
- Persons with tutors or curators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nervous System Symptoms Associated With COVID 19 : NS-COV
This study aim to prospectively evaluate the neuropsychiatric symptoms of patients infected with the SARS-CoV-2 virus by a standardized neuropsychiatric examination : the global CASE scale (Clinical Assessment Scale in Autoimmune Encephalitis), and the prevalence of disturbances of consciousness, focal neurological deficit, cognitive impairment, headache, anosmia, sleep disturbances, impaired autonomic nervous system and peritraumatic stress.
- Conditions
- Covid19
- Being tested
- NEURO +, NEURO -
- Keywords
- Nervous system, coronavirus, SARS-CoV-2, Nervous system symptoms
- Medical subject headings
- COVID-19, Neurologic Manifestations, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEURO +Other
The participants will undergo several questionnaires after their classic clinical evaluation allowing to determine the Clinical Assessment Scale in Autoimmune Encephalitis (CASE) score :
- The dissociative peri-traumatic experiences questionnaire (Birmes et al., 2005)
- the Peri traumatic distress inventory (Jehel et al., 2005)
- and the Shortness, Trembling, Racing, Sweating (STRS) (Bracha et al., 2004)
Neuro + patients will also have a Brain MRI, cerebrospinal fluid analysis, EEG, as well as an ambulatory sleep recording and electromyography depending on the symptoms observed.
NEURO -Other
The participants will undergo several questionnaires after their classic clinical evaluation allowing to determine the Clinical Assessment Scale in Autoimmune Encephalitis (CASE) score :
- The dissociative peri-traumatic experiences questionnaire (Birmes et al., 2005)
- the Peri traumatic distress inventory (Jehel et al., 2005)
- and the Shortness, Trembling, Racing, Sweating (STRS) (Bracha et al., 2004)
| Study group | Role | What they receive |
|---|---|---|
| NEURO + | Other | Patients "neuro +" are those with a CASE score ≥ 2, "Neuro +" patients will benefit from additional evaluations using paraclinical examinations Receives: Other: NEURO + |
| NEURO - | Other | Patients "neuro -" are those with a CASE score < 2 Receives: Other: NEURO - |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients in the Neuro + and Neuro- groups
The percentage is deducted from the score on a global scale by the Clinical Assessment Scale in Autoimmune Between 0 and 1, patients will be classified in the Neuro group, if this score is greater than or equal to 2, patients will be classified in the Neuro + group.
Measured: Baseline T0 : inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start2 Apr 2020
- Primary completion7 May 2020
- Study completion2 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This is an observational, prospective, cross-sectional and monocentric cohort study
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie Rafiq, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922905
- Sponsor's protocol ID
- RC31/20/0178
- Acronym
- NS-COV
- Status last verified
- Jun 2021
- First submitted
- 9 Jun 2021
- Last updated
- 11 Jun 2021
- 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 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nervous System Symptoms Associated With COVID 19 : NS-COV
- ClinicalTrials.gov ID
- NCT04922905
- Acronym / sponsor ID
- NS-COV / RC31/20/0178
- Conditions
- Covid19
- Keywords
- Nervous system, coronavirus, SARS-CoV-2, Nervous system symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 2 Apr 2020 (actual)
- Primary completion
- 7 May 2020 (actual)
- Study completion
- 2 Apr 2021 (actual)
- First posted
- 11 Jun 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.
This study aim to prospectively evaluate the neuropsychiatric symptoms of patients infected with the SARS-CoV-2 virus by a standardized neuropsychiatric examination : the global CASE scale (Clinical Assessment Scale in Autoimmune Encephalitis), and the prevalence of disturbances of consciousness, focal neurological deficit, cognitive impairment, headache, anosmia, sleep disturbances, impaired autonomic nervous system and peritraumatic stress.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an observational, prospective, cross-sectional and monocentric cohort study
| Arm | Type | Receives |
|---|---|---|
| NEURO + | Other | Other: NEURO +Patients "neuro +" are those with a CASE score ≥ 2, "Neuro +" patients will benefit from additional evaluations using paraclinical examinations |
| NEURO - | Other | Other: NEURO -Patients "neuro -" are those with a CASE score < 2 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being hospitalized at the Toulouse University Hospital for a COVID-19 infection proven by a probable PCR or COVID-type examination on the chest scan
- Have given oral consent for the collection of clinical neurological data
- Be in a clinical state compatible with a 30-minute neurological examination
- Be French-speaking
- Be affiliated to a Social Security scheme
Key exclusion criteria (4 listed)
- Refusal of the neurological examination
- History of neurological pathology at a severe stage
- Pregnant or breastfeeding woman
- Persons with tutors or curators
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 |
|---|---|---|
| NEURO +The participants will undergo several questionnaires after their classic clinical evaluation allowing to determine the Clinical Assessment Scale in Autoimmune Encephalitis (CASE) score : * The dissociative peri-traumatic experiences questionnaire (Birmes et al., 2005) * the Peri traumatic distress inventory (Jehel et al., 2005) * and the Shortness, Trembling, Racing, Sweating (STRS) (Bracha et al., 2004) Neuro + patients will also have a Brain MRI, cerebrospinal fluid analysis, EEG, as well as an ambulatory sleep recording and electromyography depending on the symptoms observed. | Other | NEURO + |
| NEURO -The participants will undergo several questionnaires after their classic clinical evaluation allowing to determine the Clinical Assessment Scale in Autoimmune Encephalitis (CASE) score : * The dissociative peri-traumatic experiences questionnaire (Birmes et al., 2005) * the Peri traumatic distress inventory (Jehel et al., 2005) * and the Shortness, Trembling, Racing, Sweating (STRS) (Bracha et al., 2004) | Other | NEURO - |
Primary outcome
percentage of patients in the Neuro + and Neuro- groups
Time frame: Baseline T0 : inclusion visit
The percentage is deducted from the score on a global scale by the Clinical Assessment Scale in Autoimmune Between 0 and 1, patients will be classified in the Neuro group, if this score is greater than or equal to 2, patients will be classified in the Neuro + group.
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 11 Jun 2021.
- 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.
Marie Rafiq, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEURO + and NEURO - in people with Covid19, run by University Hospital, Toulouse 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 5 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: finished, as of the sponsor's last update on 11 Jun 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?
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?
percentage of patients in the Neuro + and Neuro- groups (time frame: Baseline T0 : inclusion visit). 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 11 Jun 2021.