Neurologic ManifestationsCoCo-NeuroNCT04362930
Cohort of Patients With Covid-19 Presenting Neurological or Psychiatric Disorders (CoCo-Neurosciences)
An observational study of Neurologic Manifestations and Psychiatric Disorders, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Covid-19 pandemic now affects more than two million people worldwide. The neurotropism of the virus is assumed by its frequent association with neurological symptoms (anosmia, ageusia, headaches) but the extent of the central or peripheral nervous system involvement and the associated symptomatology remain poorly… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurologic Manifestations, Psychiatric Disorders, COVID-19
- How many people
- 730 participants
- Where
- 1 siteFrance
- Study dates
- 27 Apr 2020to 30 Jun 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Covid-19 infection showing neurological or psychiatric symptoms and patients initially followed for a neurological or psychiatric pathology, suffering from a Covid-19 infection
Who may be able to join
- Age of 18 years or over
- Patient followed for a neurological or psychiatric pathology OR Patient consulting and presenting a neurological or psychiatric impairment AND
- Presenting a COVID-19 infection defined by at least one of the following three criteria:
- Biological diagnosis by any method for direct detection of the virus (Covid-19 positive PCR) or recent infection (serology)
- Typical chest imaging (CT scan or X-ray) in an epidemic area
- Clinical-biological data leading to a strong suspicion of current or past Covid-19 infection
- Non-opposition of the participant, relative or guardian to the research
Who cannot join
- Patient under safety measure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cohort of Patients With Covid-19 Presenting Neurological or Psychiatric Disorders: An Observational Study of the Covid-19 Neurological and Psychiatric Manifestations
Covid-19 pandemic now affects more than two million people worldwide. The neurotropism of the virus is assumed by its frequent association with neurological symptoms (anosmia, ageusia, headaches) but the extent of the central or peripheral nervous system involvement and the associated symptomatology remain poorly known for now. The main objective of this study is to describe the neurological and psychiatric manifestations occurring in the context of Covid-19 infection in patients hospitalized or followed-up in the APHP.SU hospital group. A better understanding of the neuropsychiatric impairment related to Covid-19 would improve the management of these patients in the acute phase, and knowledge of subsequent complications would allow adapting their rehabilitation and follow-up. The precise phenomenological description of these manifestations and the imaging, biology and neuropathology data will be compiled from the data collected by the physicians in charge of these patients as part of their inpatient or outpatient care. This study will also allow collecting unusual clinical manifestations from patients followed for neurological or psychiatric pathology in hospital departments and presenting a Covid-19 infection, in order to optimize the reorganization of their management, follow-up and rehabilitation in the epidemic context.
Read the detailed description
Pandemic context In December 2019, the first cases of SARS-CoV-2 coronavirus infection (Covid-19) appeared in Wuhan, Hubei Province, China. The virus quickly spread to other Chinese provinces and then to the rest of the world. The first cases in France were diagnosed on 23 January 2020 in patients who had been in China, and the number of cases rapidly increased to 100 confirmed cases on 29 February 2020. As of 16 April, 106,206 patients had been confirmed, 6,457 patients were hospitalized in intensive care units, and the number of deaths linked to Covid-19 in hospital was 10,643 (government.fr). At the same date, more than 2,065,906 cases were confirmed worldwide, with more than 137,124 deaths (jhu.edu). The most commonly reported clinical manifestation of SARS-CoV-2 infection is an infectious syndrome associated with respiratory signs.
Neurological and psychiatric manifestations of Covid-19 To date, little is known about neurological and psychiatric manifestations of Covid-19. Some authors suggested a significant proportion of patients with central neurological manifestations such as headache, confusion, seizures or strokes. Some cases of COVID-19 encephalitis have also been reported: a case of acute haemorrhagic encephalitis, and a case of encephalitis with seizure and positive SARS-CoV-2 PCR in the CSF. Neurological impairment of Covid-19 has been proposed as a contributing mechanism to respiratory failure in some patients with severe disease. Anosmia and ageusia are now recognized as common symptoms of the infection. Cases of Guillain-Barré syndrome and probable myelitis (without radiological confirmation) have also been described. Myalgia is frequently reported in patients with Covid-19 infection, but no cases of documented myopathy have been reported to date.
Patients with Covid-19 infection may also present systemic encephalopathy in the context of severe respiratory failure, associated organ failure (renal, hepatic), and iatrogenicity.
Patients hospitalized in intensive care unit for severe forms of the infection frequently present with confusion, and sometimes persistent cognitive disorders such as a dysexecutive syndrome, attention disorders, spatio-temporal disorientation. A high frequency of clinical signs of cortico-spinal bundle damage and leptomeningeal contrast images on cerebral MRI has also been reported.
Regarding psychiatric manifestations, a high prevalence of anxiety disorders and depressive syndromes was noted in patients with Covid-19. Post-traumatic stress disorder may also occur in these patients, particularly those who have suffered from severe forms of stress and have been hospitalized in intensive care units.
SARS-CoV-2 is a member of the coronavirus family and bears a strong similarity to other coronaviruses such as SARS-CoV or MERS-CoV. Clinical and preclinical knowledge of other coronaviruses suggests neurotropism of viruses of this family. In particular, infection with SARS-CoV-2 or NCoV-OC43 may cause encephalitis or encephalomyelitis. The SARS-CoV-2 virus adheres to cell membranes by interaction with ACE2 receptors, which are highly expressed on the surfaces of neurons and glial cells. The ACE2 receptor is particularly expressed in the brainstem and in regions involved in cardiovascular control including the paraventricular nucleus, the nucleus of the solitary tract. The virus could reach the nervous system via systemic circulation (viremia) or via ethmoidal microcirculation via the olfactory epithelium. Indeed, animal studies have shown that SARS-Cov can invade the brain via the olfactory epithelium via the nasal route and cause neuronal death. The virus could also infect the brain through trans-synaptic transmission from the olfactory epithelium through the ethmoidal floor to the olfactory bulb. Another mechanism of neurological damage related to Covid-19 infection could be the initiation of an immune reaction with the release of cytokines and other inflammatory proteins, leading to a breakdown of the blood-brain barrier, which amplifies neuro-inflammatory processes. Systemic inflammation and cytokines may also promote ischemic stroke. Severe coagulopathies have been reported.
Covid-19 and pre-existing neurological and psychiatric disorders SARS-CoV-2 infection could lead to the aggravation of certain pre-existing neurological and psychiatric disorders, but the potential impact of the infection in the short, medium and long term on these pathologies is still unknown.
Indeed, infections are a classic aggravating factor in many neurological pathologies, such as autoimmune pathologies, metabolic pathologies, and also neurodegenerative pathologies. Brain inflammation is recognised as an important mechanism of neurodegenerative pathologies and has also been implicated in psychiatric pathologies such as schizophrenia and depression.
Patients with cardiac or respiratory damage, particularly in the context of neuro-muscular pathologies, could particularly develop severe forms of infection. Patients with neurodegenerative pathologies often represent an elderly population, and therefore also at risk of severe forms of infection. Patients followed for inflammatory or neuro-oncological pathologies and undergoing immunosuppressive treatments or chemotherapy also represent a at-risk population. SARS-CoV-2 infection could also worsen certain psychiatric pathologies.
Public interest research Neurological and psychiatric manifestations have been reported in patients with Covid-19 but the different neuropsychiatric expressions of Covid-19 infections are currently not well characterized.
A better understanding of the neurological and psychiatric impairment related to Covid-19 could improve management of the patients in the acute phase.
Knowledge of neurological and psychiatric complications subsequently occurring would allow adapting the follow-up of these patients. The inclusion of prospective long-term follow-up data is crucial in the overall understanding of the neuropsychiatric disorders of Covid-19. Neurological complications are likely to occur at a distance from the infection or to be lately diagnosed, for instance, in patients who have been in intensive care. The collection of data from the rehabilitation follow-up of these patients is crucial in this context.
The precise phenomenological description of these manifestations and the collection of imaging, biological and neuropathological data may also allow establishing hypotheses on the pathophysiology of the neurological damage caused by Covid-19.
The impact of Covid-19 infection on pre-existing neurological and psychiatric pathologies is not known. This knowledge would optimize the reorganization of the management, follow-up and rehabilitation of these patients in the epidemic context.
In this observational, retrospective, multicentre study, the investigators aim at i) describing the clinical and paraclinical manifestations of patients with neurological or psychiatric manifestations of Covid-19 infection, and ii) describing changes in the clinical trajectories of patients with Covid-19 infection, initially followed for neurological or psychiatric pathologies.
- Conditions
- Neurologic Manifestations, Psychiatric Disorders, COVID-19
- Keywords
- COVID-19, ENCEPHALOPATHY, ENCEPHALITIS, STROKE, CONFUSION, DELIRIUM, DEPRESSION, POST TRAUMATIC STRESS DISORDER
- Medical subject headings
- Neurologic Manifestations, Mental Disorders, COVID-19, Brain Diseases, Encephalitis, Stroke, Confusion, Delirium
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 |
|---|---|---|
| Neurological and psychiatric impact of COVID-19 | Covid-19 impact in neurological or psychiatric manifestations in patients with Covid-19 infection | |
| Impact of Covid-19 in patients with neurological pathology | patients initially followed for a neurological or psychiatric pathology, suffering from a Covid-19 infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central or peripheral neurological symptoms or psychiatric symptoms observed in patients with Covid-19
Frequency of central or peripheral neurological or psychiatric symptoms observed in patients with COVID-19
Measured: 12 months
Secondary outcomes (1)
Progression of pre-existing neurological or psychiatric pathologies
Impact on neurological or psychiatric disease trajectories assessed by severity scores or subjective progression (improved, stable, impaired) during and after COVID-19 pathology in patients with pre-existing neurological and psychiatric diseases
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start27 Apr 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
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 Neurologic ManifestationsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Retrospective
- Enrolment
- 730 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362930
- Sponsor's protocol ID
- APHP200525
- Acronym
- CoCo-Neuro
- Status last verified
- Feb 2024
- First submitted
- 24 Apr 2020
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pitron V, Cantenys W, Herbelin A, Bottemanne H, Dzierzynski N, Caumes E, Mathian A, Amoura Z, Allenbach Y, Cacoub P, Parrot A, Rotge JY, Fossati P. Factors Associated With Posttraumatic Stress Symptoms 3 and 6 Months After Hospitalization for COVID-19: A Longitudinal Multicenter Study. J Clin Psychiatry. 2022 Dec 7;84(1):21m14277. doi: 10.4088/JCP.21m14277.
PubMed 36479951
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort of Patients With Covid-19 Presenting Neurological or Psychiatric Disorders: An Observational Study of the Covid-19 Neurological and Psychiatric Manifestations
- ClinicalTrials.gov ID
- NCT04362930
- Acronym / sponsor ID
- CoCo-Neuro / APHP200525
- Conditions
- Neurologic Manifestations, Psychiatric Disorders, COVID-19
- Keywords
- COVID-19, ENCEPHALOPATHY, ENCEPHALITIS, STROKE, CONFUSION, DELIRIUM, DEPRESSION, POST TRAUMATIC STRESS DISORDER
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 730 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 27 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.
Covid-19 pandemic now affects more than two million people worldwide. The neurotropism of the virus is assumed by its frequent association with neurological symptoms (anosmia, ageusia, headaches) but the extent of the central or peripheral nervous system involvement and the associated symptomatology remain poorly known for now. The main objective of this study is to describe the neurological and psychiatric manifestations occurring in the context of Covid-19 infection in patients hospitalized or followed-up in the APHP.SU hospital group. A better understanding of the neuropsychiatric impairment related to Covid-19 would improve the management of these patients in the acute phase, and knowledge of subsequent complications would allow adapting their rehabilitation and follow-up. The precise phenomenological description of these manifestations and the imaging, biology and neuropathology data will be compiled from the data collected by the physicians in charge of these patients as part of their inpatient or outpatient care. This study will also allow collecting unusual clinical manifestations from patients followed for neurological or psychiatric pathology in hospital departments and presenting a Covid-19 infection, in order to optimize the reorganization of their management, follow-up and rehabilitation in the epidemic context.
Detailed description
Pandemic context In December 2019, the first cases of SARS-CoV-2 coronavirus infection (Covid-19) appeared in Wuhan, Hubei Province, China. The virus quickly spread to other Chinese provinces and then to the rest of the world. The first cases in France were diagnosed on 23 January 2020 in patients who had been in China, and the number of cases rapidly increased to 100 confirmed cases on 29 February 2020. As of 16 April, 106,206 patients had been confirmed, 6,457 patients were hospitalized in intensive care units, and the number of deaths linked to Covid-19 in hospital was 10,643 (government.fr). At the same date, more than 2,065,906 cases were confirmed worldwide, with more than 137,124 deaths (jhu.edu). The most commonly reported clinical manifestation of SARS-CoV-2 infection is an infectious syndrome associated with respiratory signs.
Neurological and psychiatric manifestations of Covid-19 To date, little is known about neurological and psychiatric manifestations of Covid-19. Some authors suggested a significant proportion of patients with central neurological manifestations such as headache, confusion, seizures or strokes. Some cases of COVID-19 encephalitis have also been reported: a case of acute haemorrhagic encephalitis, and a case of encephalitis with seizure and positive SARS-CoV-2 PCR in the CSF. Neurological impairment of Covid-19 has been proposed as a contributing mechanism to respiratory failure in some patients with severe disease. Anosmia and ageusia are now recognized as common symptoms of the infection. Cases of Guillain-Barré syndrome and probable myelitis (without radiological confirmation) have also been described. Myalgia is frequently reported in patients with Covid-19 infection, but no cases of documented myopathy have been reported to date.
Patients with Covid-19 infection may also present systemic encephalopathy in the context of severe respiratory failure, associated organ failure (renal, hepatic), and iatrogenicity.
Patients hospitalized in intensive care unit for severe forms of the infection frequently present with confusion, and sometimes persistent cognitive disorders such as a dysexecutive syndrome, attention disorders, spatio-temporal disorientation. A high frequency of clinical signs of cortico-spinal bundle damage and leptomeningeal contrast images on cerebral MRI has also been reported.
Regarding psychiatric manifestations, a high prevalence of anxiety disorders and depressive syndromes was noted in patients with Covid-19. Post-traumatic stress disorder may also occur in these patients, particularly those who have suffered from severe forms of stress and have been hospitalized in intensive care units.
SARS-CoV-2 is a member of the coronavirus family and bears a strong similarity to other coronaviruses such as SARS-CoV or MERS-CoV. Clinical and preclinical knowledge of other coronaviruses suggests neurotropism of viruses of this family. In particular, infection with SARS-CoV-2 or NCoV-OC43 may cause encephalitis or encephalomyelitis. The SARS-CoV-2 virus adheres to cell membranes by interaction with ACE2 receptors, which are highly expressed on the surfaces of neurons and glial cells. The ACE2 receptor is particularly expressed in the brainstem and in regions involved in cardiovascular control including the paraventricular nucleus, the nucleus of the solitary tract. The virus could reach the nervous system via systemic circulation (viremia) or via ethmoidal microcirculation via the olfactory epithelium. Indeed, animal studies have shown that SARS-Cov can invade the brain via the olfactory epithelium via the nasal route and cause neuronal death. The virus could also infect the brain through trans-synaptic transmission from the olfactory epithelium through the ethmoidal floor to the olfactory bulb. Another mechanism of neurological damage related to Covid-19 infection could be the initiation of an immune reaction with the release of cytokines and other inflammatory proteins, leading to a breakdown of the blood-brain barrier, which amplifies neuro-inflammatory processes. Systemic inflammation and cytokines may also promote ischemic stroke. Severe coagulopathies have been reported.
Covid-19 and pre-existing neurological and psychiatric disorders SARS-CoV-2 infection could lead to the aggravation of certain pre-existing neurological and psychiatric disorders, but the potential impact of the infection in the short, medium and long term on these pathologies is still unknown.
Indeed, infections are a classic aggravating factor in many neurological pathologies, such as autoimmune pathologies, metabolic pathologies, and also neurodegenerative pathologies. Brain inflammation is recognised as an important mechanism of neurodegenerative pathologies and has also been implicated in psychiatric pathologies such as schizophrenia and depression.
Patients with cardiac or respiratory damage, particularly in the context of neuro-muscular pathologies, could particularly develop severe forms of infection. Patients with neurodegenerative pathologies often represent an elderly population, and therefore also at risk of severe forms of infection. Patients followed for inflammatory or neuro-oncological pathologies and undergoing immunosuppressive treatments or chemotherapy also represent a at-risk population. SARS-CoV-2 infection could also worsen certain psychiatric pathologies.
Public interest research Neurological and psychiatric manifestations have been reported in patients with Covid-19 but the different neuropsychiatric expressions of Covid-19 infections are currently not well characterized.
A better understanding of the neurological and psychiatric impairment related to Covid-19 could improve management of the patients in the acute phase.
Knowledge of neurological and psychiatric complications subsequently occurring would allow adapting the follow-up of these patients. The inclusion of prospective long-term follow-up data is crucial in the overall understanding of the neuropsychiatric disorders of Covid-19. Neurological complications are likely to occur at a distance from the infection or to be lately diagnosed, for instance, in patients who have been in intensive care. The collection of data from the rehabilitation follow-up of these patients is crucial in this context.
The precise phenomenological description of these manifestations and the collection of imaging, biological and neuropathological data may also allow establishing hypotheses on the pathophysiology of the neurological damage caused by Covid-19.
The impact of Covid-19 infection on pre-existing neurological and psychiatric pathologies is not known. This knowledge would optimize the reorganization of the management, follow-up and rehabilitation of these patients in the epidemic context.
In this observational, retrospective, multicentre study, the investigators aim at i) describing the clinical and paraclinical manifestations of patients with neurological or psychiatric manifestations of Covid-19 infection, and ii) describing changes in the clinical trajectories of patients with Covid-19 infection, initially followed for neurological or psychiatric pathologies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurological and psychiatric impact of COVID-19 | – | –Covid-19 impact in neurological or psychiatric manifestations in patients with Covid-19 infection |
| Impact of Covid-19 in patients with neurological pathology | – | –patients initially followed for a neurological or psychiatric pathology, suffering from a Covid-19 infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Covid-19 infection showing neurological or psychiatric symptoms and patients initially followed for a neurological or psychiatric pathology, suffering from a Covid-19 infection
Key inclusion criteria (7 listed)
- Age of 18 years or over
- Patient followed for a neurological or psychiatric pathology OR Patient consulting and presenting a neurological or psychiatric impairment AND
- Presenting a COVID-19 infection defined by at least one of the following three criteria:
- Non-opposition of the participant, relative or guardian to the research
Key exclusion criteria (1 listed)
- Patient under safety measure
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
Central or peripheral neurological symptoms or psychiatric symptoms observed in patients with Covid-19
Time frame: 12 months
Frequency of central or peripheral neurological or psychiatric symptoms observed in patients with COVID-19
1 secondary outcome
Progression of pre-existing neurological or psychiatric pathologies
Time frame: 12 months
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 5 Feb 2024.
- Derived from this study: PubMed 36479951Pitron V, Cantenys W, Herbelin A, Bottemanne H, Dzierzynski N, Caumes E, Mathian A, Amoura Z, Allenbach Y, Cacoub P, Parrot A, Rotge JY, Fossati P. Factors Associated With Posttraumatic Stress Symptoms 3 and 6 Months After Hospitalization for COVID-19: A Longitudinal Multicenter Study. J Clin Psychiatry. 2022 Dec 7;84(1):21m14277. doi: 10.4088/JCP.21m14277.
- CoCo-Neurosciences project is described on the Paris Brain Institute websiteLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Neurologic Manifestations and Psychiatric Disorders, run by Assistance Publique - Hôpitaux de Paris 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 7 inclusion and 1 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 5 Feb 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 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?
Central or peripheral neurological symptoms or psychiatric symptoms observed in patients with Covid-19 (time frame: 12 months). 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 NCT04362930, 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 5 Feb 2024.