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

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ClinicalTrials.gov Identifier: NCT04576351
Recruitment Status : Recruiting
First Posted : October 6, 2020
Last Update Posted : March 3, 2021
Sponsor:
Collaborators:
University Hospital, Akershus
Haukeland University Hospital
Helse Stavanger HF
St. Olavs Hospital
University Hospital of North Norway
Vestre Viken Hospital Trust
Sykehuset Telemark
Sykehuset Innlandet HF
Ostfold Hospital Trust
The Hospital of Vestfold
Sorlandet Hospital HF
Nordlandssykehuset HF
Møre og Romsdal Hospital Trust
Information provided by (Responsible Party):
Anne Hege Aamodt, Oslo University Hospital

Brief 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 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,

Condition or disease Intervention/treatment
Covid19 Other: Observation

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Norwegian Study of Nervous System Manifestations and Sequelae After COVID-19
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Group/Cohort Intervention/treatment
1

Sub 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.

Other: Observation
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.

2

Sub 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.

Other: Observation
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.




Primary Outcome Measures :
  1. Rate of peripheral and central nervous affection [ Time Frame: 6 months ]
    Rate of neurological manifestations of COVID-19

  2. Rate of peripheral and central nervous affection [ Time Frame: 12 months ]
    Rate of neurological manifestations of COVID-19

  3. Rate of psychiatric disorders at 6-months follow-up [ Time Frame: 6 months ]
    Rate of psychiatric disorders as manifestations of COVID-19

  4. Rate of psychiatric disorders at 12-months follow-up [ Time Frame: 12 months ]
    Rate of psychiatric disorders as manifestations of COVID-19

  5. Neuropsychological function at 6-months follow up [ Time Frame: 6 months ]
    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

  6. Neuropsychological function at 12-months follow up and change in function from 6 to 12 months. [ Time Frame: 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.


Secondary Outcome Measures :
  1. Rate of stroke at 6-months follow up [ Time Frame: 6 months ]
    Rate of stroke

  2. Rate of stroke at 12-months follow up [ Time Frame: 12 months ]
    Rate of stroke

  3. Rate of death at 6-months follow-up [ Time Frame: 6 months ]
    Rate of death

  4. Rate of death at 12-months follow-up [ Time Frame: 12 months ]
    Rate of death

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

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

  7. Rate of myopathy at 6-months follow-up [ Time Frame: 6 months ]
    Rate of myopathy

  8. Rate of myopathy at 12-months follow-up [ Time Frame: 12 months ]
    Rate of myopathy

  9. Rate of brain MRI pathology at 6-months follow-up [ Time Frame: 6 months ]
    Rate of brain MRI pathology

  10. Rate of brain MRI pathology at 12-months follow-up [ Time Frame: 12 months ]
    Rate of brain MRI pathology

  11. Levels of serum neurofilaments at 6-months follow-up [ Time Frame: 6 months ]
    Levels of serum eurofilaments

  12. Levels of serum neurofilaments at 12-months follow-up [ Time Frame: 12 months ]
    Levels of serum neurofilaments

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

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

  15. Duration of hospital and rehabilitation stay [ Time Frame: 6 months ]
    Duration of hospital and rehabilitation stay at 6-months follow up

  16. Duration of hospital and rehabilitation stay [ Time Frame: 12 months ]
    Duration of hospital and rehabilitation stay at 12-months follow up



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Sub cohort 1:

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • If still alive, no willingness and ability to participate in all follow-up examinations.

Sub cohort 2:

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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:

  1. Sufficient Norwegian or English speaking in order to fulfill the tests.
  2. MoCA score > 18.
  3. Hospital has C-L psychiatrist/neuropsychologists that participate in the study or collaborate with C-L psychiatrist/psychiatrist/clinical psychologists at nearby hospitals.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04576351


Contacts
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Contact: Anne Hege Aamodt, MD, PhD 95867270 ext 47 a.h.aamodt@medisin.uio.no
Contact: Trine H Popperud, MD, PhD 90502709 tripop@ous-hf.no

Locations
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Norway
Sørlandet Hospital Trust Not yet recruiting
Arendal, Norway
Contact: Randi Eikeland, MD         
Haukeland University Hospital Recruiting
Bergen, Norway
Contact: Øyvind G Torkildsen, MD PhD Prof         
Contact: MD,PhD,Prof         
Nordlandssykehuset Not yet recruiting
Bodo, Norway
Contact: Hilde K Ofte, MD PhD         
Vestre Viken Hospital Trust Drammen Recruiting
Drammen, Norway
Contact: Mette Bergum, MD         
Østfold Hospital Trust Kalnes Recruiting
Grålum, Norway
Contact: Barbara Ratajczak-Tretel, MD         
Sørlandet Hospital Trust, Kristiansand Recruiting
Kristiansand, Norway
Contact: Martin Weisshaar, MD         
Innlandet Hospital Trust Recruiting
Lillehammer, Norway
Contact: Anette Huuse Farmen, MD PhD         
Akershus University Hospital Not yet recruiting
Lørenskog, Norway
Contact: Tormod Fladby, MD PhD Prof       tormod.fladby@medisin.uio.no   
Møre og Romsdal Hospital Trust Recruiting
Molde, Norway
Contact: Guttorm Eldøen, MD       guttorm.eldoen@helse-mr.no   
Oslo University Hospital Recruiting
Oslo, Norway, 0424
Contact: Anne Hege Aamodt, MD PhD    +4723074976    a.h.aamodt@medisin.uio.no   
Contact: Trine H Popperud, MD PhD    +47 91502770    tripop@ous-hf.no   
Principal Investigator: Marion Boldingh, MD PhD         
Principal Investigator: Trine H Popperud, MD PhD         
Sub-Investigator: Einar A Høgestøl, MD PhD         
Ostfold Hospital Trust Recruiting
Sarpsborg, Norway
Contact: Barbara Ratajczak-Tretel, MD       barbara.ratajczak@so-hf.no   
Skien Hospital Recruiting
Skien, Norway
Contact: Heidi Øyen Flemmen, MD       fleh@sthf.no   
Stavanger University Hospital Not yet recruiting
Stavanger, Norway
Contact: Martin Kurz, MD PhD Prof       friedrich.martin.wilhelm.kurz@sus.no   
University Hospital of North Norway Not yet recruiting
Tromsø, Norway
Contact: Linn H Steffensen, MD PhD         
St. Olav Hospital Recruiting
Trondheim, Norway
Contact: Christian Samsonsen, MD PhD         
Sponsors and Collaborators
Oslo University Hospital
University Hospital, Akershus
Haukeland University Hospital
Helse Stavanger HF
St. Olavs Hospital
University Hospital of North Norway
Vestre Viken Hospital Trust
Sykehuset Telemark
Sykehuset Innlandet HF
Ostfold Hospital Trust
The Hospital of Vestfold
Sorlandet Hospital HF
Nordlandssykehuset HF
Møre og Romsdal Hospital Trust
Investigators
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Principal Investigator: Anne Hege Aamodt, MD, PhD Oslo University Hospital
Study Director: Hanne F Harbo, MD,PhD,Prof Oslo University Hospital
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Responsible Party: Anne Hege Aamodt, Senior Consultant, MD, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04576351    
Other Study ID Numbers: 152727
First Posted: October 6, 2020    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anne Hege Aamodt, Oslo University Hospital:
neurology