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Covid19NeuroCovidNCT04576351

The Norwegian Study of Nervous System Manifestations and Sequelae After COVID-19

An observational study of Covid19, run by Oslo University Hospital at 15 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Neurologic, neuropsychological and neuropsychiatric symptoms, signs and diagnoses are increasingly being reported in COVID-19 patients. However, the extent and implications of such "NeuroCOVID" involvement, as well as blood and MRI biomarkers for neurological and psychiatric COVID-19-affection and treatments, warrants… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19
What is being tested?
Observation
How many people
175 participants
Where
15 sitesNorway
Study dates
1 Sep 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Sub cohort 1: Participants in the WHO NOR Solidarity multi-center trial on the efficacy of different anti-viral drugs in SARS CoV-2 infected patients. Sub cohort 2: Patients with COVID-19 and new neurological, neuropsychological or neuropsychiatric symptoms and/or signs admitted to the Norwegian Departments of Neurology or other relevant Departments (both hospitalized and outpatient visits) or participants from other COVID-19 studies than the NOR Solidarity Study. Number of participants: Based on the number of included participants in the NOR Solidarity trial and the number of infected individuals we are planning to include 150 participants in the NeuroCOVID-19 study.

Who may be able to join

  • Consenting adults (age ≥18 years) hospitalized with definite COVID-19 included in the WHO: The NOR Solidarity multicenter trial on the efficacy of different anti-viral drugs in SARS CoV-2 infected patients and willingness to participate in the NeuroCOVID study.
  • Consenting adults (age ≥18 years) with COVID-19 and new neurological, neuropsychological or neuropsychiatric symptoms and/or signs or participants from other COVID-19 studies than the NOR Solidary Study.

Who cannot join

  • If still alive, no willingness and ability to participate in all follow-up examinations.
  • Sub cohort 2:
  • If still alive, no willingness and ability to participate in all follow-up examinations.
  • All participants in both sub cohorts will after the visit by neurologists be assessed by neuropsychologists and psychiatrist at 6- and 12-month follow-up if the following criteria are fulfilled:
  • Sufficient Norwegian or English speaking in order to fulfill the tests.
  • MoCA score > 18.
  • Hospital has C-L psychiatrist/neuropsychologists that participate in the study or collaborate with C-L psychiatrist/psychiatrist/clinical psychologists at nearby hospitals.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Norway15 sites
  • Sørlandet Hospital Trust

    Arendal

  • Haukeland University Hospital

    Bergen

  • Nordlandssykehuset

    Bodø

  • Vestre Viken Hospital Trust Drammen

    Drammen

  • Østfold Hospital Trust Kalnes

    Grålum

  • Sørlandet Hospital Trust, Kristiansand

    Kristiansand

  • Innlandet Hospital Trust

    Lillehammer

  • Akershus University Hospital

    Lørenskog

  • Møre og Romsdal Hospital Trust

    Molde

  • Oslo University Hospital

    Oslo, 0424

  • Ostfold Hospital Trust

    Sarpsborg

  • Skien Hospital

    Skien

  • Stavanger University Hospital

    Stavanger

  • University Hospital of North Norway

    Tromsø

  • St. Olav Hospital

    Trondheim

Other trials in Norway

About this study

Neurologic, neuropsychological and neuropsychiatric symptoms, signs and diagnoses are increasingly being reported in COVID-19 patients. However, the extent and implications of such "NeuroCOVID" involvement, as well as blood and MRI biomarkers for neurological and psychiatric COVID-19-affection and treatments, warrants further studies. The investigator will perform a national study with clinical and biomarker assessments of NeuroCOVID in approximately 150 Norwegian patients, recruited from ongoing COVID-studies in Norway as well as from neurological departments in Norway. The investigator will define the burden of neurological, psychological and psychiatric complications of COVID-19 disease and identify clinical characteristics and biomarkers for both short- and long-term neurological treatment and rehabilitation. Blood samples for biomarker analyses, brain MRI, clinical neurological, neurophysiological and neuropsychological assessments will be performed at 6 and 12 moths after acute disease,

Read the detailed description

Corona virus (CoV) may have deleterious effects on the nervous system. As the number of individuals infected by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is increasing, more and more neurological, neuropsychological and neuropsychiatric symptoms are being reported in COVID-19 patients. Neurologists and psychiatrist, in turn, may increasingly find themselves involved in caring for patients with the novel virus.

Sars-CoV-2 usually enter the body via the enzyme angiotensin converting enzyme 2 (ACE2) in alveolar cells in the lungs. However, ACE2 is expressed in a number of other tissues and cells, such as mucous membranes of the eyes, nose and oral cavity, neurons, glia cells and endothelial cells, including those in the brain, making it a potential target of the virus.

There are several possible mechanisms for nervous system affection in COVID-19. Firstly, transneuronal transport of viruses through the olfactory nerve to the brain can induce direct injury. Sars-CoV-2 has been detected in cerebrospinal fluid in patients with encephalitis and meningitis. A second type of injury may result from an excessive immune response in the form of a "cytokine storm". Cytokines can cross the blood-brain barrier and are associated with acute necrotizing encephalopathy. A third mechanism of nervous tissue damage results from unintended host immune response effects after an acute infection. Examples of this type of indirect CNS injury are Guillain-Barré syndrome (GBS) and brain and spine demyelination. A fourth mechanism is an indirect viral injury that results from the effects of systemic illness, hypoxia and in some cases hypercoagulability, a prominent feature of severe COVID-19. Most cases of COVID-19-related neurologic complications appear to fall into this category. Severely ill patients in the intensive care unit may develop neurologic symptoms such as encephalopathy, critical illness myopathy, and neuropathy. This is common in both COVID-19 and in other diseases.

There have been several reports of nervous system manifestations in COVID-19. In a retrospective study from Wuhan China with 214 consecutive hospitalized patients, 1/3 had neurologic manifestations and nearly one half of those with severe infection. Common central nervous system (CNS) symptoms were dizziness, headache, and impaired consciousness or symptoms of acute cerebrovascular disease. The most common peripheral nervous system (PNS) symptoms included impaired taste, smell, or vision, and nerve pain. Skeletal muscular injury symptoms were also frequently reported. COVID-19 patients with CNS symptoms had lower lymphocyte levels and platelet counts and higher blood urea nitrogen levels compared to their counterparts without CNS symptoms. This may be indicative of immunosuppression in patients with COVID-19 and CNS symptoms or it may be manifestations coexisting in the same patient. Systematic brain imaging and measurements of neuron- or brain-specific biomarkers may increase the knowledge regarding nervous system manifestations in COVID-19 but were not performed in this study. Case report series with types of CNS or PNS manifestations, such as ischemic or hemorrhagic stroke, Guillain Barré syndrome, encephalitis, meningitis and toxic hemorrhagic necrotizing encephalopathy have been described. Furthermore, post infection surveillance will be necessary to identify possible post-COVID neurologic syndromes.

Moreover, COVID-19 is a significant psychological stressor, which may in addition to the neurological manifestations contribute to neuropsychiatric and neuropsychological sequela. Past respiratory viral pandemics have been associated with neuropsychiatric symptoms that may arise acutely or after variable periods of time. The long-term effect on neuropsychological functioning and the prevalence of neuropsychiatric symptoms due to COVID-19 are currently unknown. However, patients with COVID-19 are at risk of developing delirium that may cause long term cognitive impairment. Furthermore, Sars-CoV-2 proteins have been shown to interact with human proteins in multiple aging-related processes and CNS symptoms in patients with COVID-19 may put them at risk of neurocognitive complications. Given the global burden of COVID-19, long term neurocognitive complications are of importance to recognize.

Previously anxiety, depression and trauma related symptoms have been associated with CoV outbreaks. In survivors of SARS-CoV-1 active psychiatric illnesses were diagnosed in more than 40%, (PTSD (54%), depression (39%), somatoform pain disorders (36%), panic disorder (32%) and OCD (15%)) post-infection compared to pre-infection prevalence of less than 3%, and more than 27% had fatigue symptoms. Moreover, antibodies against CoV have been found in both psychoses and affective disorders. However, it is not known to which extent neuropsychological and psychiatric symptoms and disorders after COVID-19 are related to the psychological stressor or to CNS sequela after Covid-19 or to both.

Our hypotheses in this project are:

  1. Nervous system manifestations and neurological sequelae are common after COVID 19.
  2. Biomarkers in blood can be used to assess neurological manifestations and sequelae in COVID-19 patients at 6- and 12-months follow-up.
  3. Severe COVID-19 infection predicts neurological manifestations and sequelae at 6- and 12-months follow-up.
  4. Psychiatric disorders, especially anxiety and depressive disorders, but also psychotic and somatoform disorders are common after COVID-19, either due to CNS sequelae or manifestation or to perceived distress/strain.
  5. Neuropsychological sequelae are common after COVID-19 either due to CNS sequelae or manifestation or to perceived distress/strain.
  6. Biomarkers and imaging findings can be used to predict neuropsychiatric manifestations after Covid-19 at 6- and 12- months follow up.
  7. Biomarkers in blood and imaging findings can be used to predict neuropsychological manifestations after Covid-19 at 6- and 12- months follow up.
  8. Severe COVID-19 infection predicts neuropsychiatric and psychiatric disorders at 6- and 12-months follow-up.
  9. Severe COVID-19 infection predicts neuropsychological sequelae at 6- and 12-months follow-up.
Conditions
Covid19
Being tested
Observation
Keywords
neurology
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObservationOther

    The study is a multi-center Norwegian prospective observational clinical study of the occurence of neurological, neuropsychological and psychiatric manifestations and sequelae in patients with COVID-19 at 6- and 12-months follow-up.

Study groups in NCT04576351
Study groupRoleWhat they receive
1Sub cohort 1: Participants in the WHO NOR Solidarity multicenter trial on the efficacy of different anti-viral drugs in SARS CoV-2 infected patients. Eligibility: consenting adults (age ≥18) hospitalized with definite COVID-19 included in the WHO COVID-19 Study. Participants invited to join the study will be those who are admitted to a collaborating hospital; no wider recruitment efforts are expected.
Receives: Other: Observation
2Sub cohort 2: Patients with COVID-19 and neurological symptoms related to COVID-19 admitted to the Norwegian Departments of Neurology or other relevant Departments (both hospitalized and outpatient visits) and persons with neurological symptoms participating in other COVID-19 studies and not already participating in the WHO NOR Solidarity multicenter trial.
Receives: Other: Observation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of peripheral and central nervous affection

    Rate of neurological manifestations of COVID-19

    Measured: 6 months

  2. Rate of peripheral and central nervous affection

    Rate of neurological manifestations of COVID-19

    Measured: 12 months

  3. Rate of psychiatric disorders at 6-months follow-up

    Rate of psychiatric disorders as manifestations of COVID-19

    Measured: 6 months

  4. Rate of psychiatric disorders at 12-months follow-up

    Rate of psychiatric disorders as manifestations of COVID-19

    Measured: 12 months

  5. Neuropsychological function at 6-months follow up

    Neuropsychological function at 6-months follow up months after COVID-19. MoCA with score > 18 are eligible to further testing. Neuropsychological testing cover the most important domains of cognitive function enabling valid test data across different functional domains

    Measured: 6 months

  6. Neuropsychological function at 12-months follow up and change in function from 6 to 12 months.

    Neuropsychological function at 12-months follow up months after COVID-19. When MoCA > 18 at 6 months, MoCA is not done at 12 months. Neuropsychological testing cover the most important domains of cognitive function enabling valid test data across different functional domains.

    Measured: 12 months

Secondary outcomes (16)
  1. Rate of stroke at 6-months follow up

    Rate of stroke

    Measured: 6 months

  2. Rate of stroke at 12-months follow up

    Rate of stroke

    Measured: 12 months

  3. Rate of death at 6-months follow-up

    Rate of death

    Measured: 6 months

  4. Rate of death at 12-months follow-up

    Rate of death

    Measured: 12 months

  5. Rate of peripheral nervous affection assessed by clinical neurological examination and/or EMG/neurography at 6-months follow-up

    Rate of peripheral nervous affection assessed by clinical neurological examination and/or EMG/neurography

    Measured: 6 months

  6. Rate of peripheral nervous affection assessed by clinical neurological examination and/or EMG/neurography at 12-months follow-up

    Rate of peripheral nervous affection assessed by clinical neurological examination and/or EMG/neurography

    Measured: 12 months

  7. Rate of myopathy at 6-months follow-up

    Rate of myopathy

    Measured: 6 months

  8. Rate of myopathy at 12-months follow-up

    Rate of myopathy

    Measured: 12 months

  9. Rate of brain MRI pathology at 6-months follow-up

    Rate of brain MRI pathology

    Measured: 6 months

  10. Rate of brain MRI pathology at 12-months follow-up

    Rate of brain MRI pathology

    Measured: 12 months

  11. Levels of serum neurofilaments at 6-months follow-up

    Levels of serum eurofilaments

    Measured: 6 months

  12. Levels of serum neurofilaments at 12-months follow-up

    Levels of serum neurofilaments

    Measured: 12 months

  13. Rate of post-COVID neurological, cognitive or neuropsychiatric manifestations in the treatment arms at 6-months follow-up

    Rate of post-COVID neurological, cognitive or neuropsychiatric manifestations in the treatment arms

    Measured: 6 months

  14. Rate of post-COVID neurological, cognitive or neuropsychiatric manifestations in the treatment arms at 12-months follow-up

    Rate of post-COVID neurological, cognitive or neuropsychiatric manifestations in the treatment arms

    Measured: 12 months

  15. Duration of hospital and rehabilitation stay

    Duration of hospital and rehabilitation stay at 6-months follow up

    Measured: 6 months

  16. Duration of hospital and rehabilitation stay

    Duration of hospital and rehabilitation stay at 12-months follow up

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2020
  2. Study start1 Sep 2020
  3. Primary completion31 May 2023
  4. Study completion31 Dec 2023

Resources

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
175 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04576351
Sponsor's protocol ID
152727
Acronym
NeuroCovid
Status last verified
Jul 2024
First submitted
10 Sep 2020
Last updated
3 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Aamodt AH, Ueland T, Boldingh M, Bezgal BE, Argren MB, Dunne CA, Otterdal K, Gregersen I, Bjerkeli V, Michelsen AE, Husoy A, Morsund AH, Devik K, Poole AC, Gjendemsjo KB, Schluter K, Mathisen SM, Aalstad-Johansen M, Skattor TH, Sonnervik J, Boye TB, Popperud TH, Hogestol EA, Harbo HF, Lund-Johansen F, Aukrust P, Tronvik E, Dahl TB, Halvorsen BE. Altered amyloid plasma profile in patients with disabling headaches after SARS-CoV-2 infection and vaccination. BMJ Neurol Open. 2025 Aug 26;7(2):e001013. doi: 10.1136/bmjno-2024-001013. eCollection 2025.

    PubMed 40881041

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19, run by Oslo University Hospital at 15 sites in Norway.

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 2 inclusion and 7 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 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Norway. 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?

Rate of peripheral and central nervous affection (time frame: 6 months). The study lists 6 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 NCT04576351, 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 3 Jul 2024.

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