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

NCT04576351 | Completed DMC

• 1 other identifier: 152727
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 15

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,

Conditions

Covid19

Keywords

neurology

Outcome Measures

Primary Outcomes (6)

• Rate of peripheral and central nervous affection

  Rate of neurological manifestations of COVID-19

  6 months

• Rate of peripheral and central nervous affection

  Rate of neurological manifestations of COVID-19

  12 months

• Rate of psychiatric disorders at 6-months follow-up

  Rate of psychiatric disorders as manifestations of COVID-19

  6 months

• Rate of psychiatric disorders at 12-months follow-up

  Rate of psychiatric disorders as manifestations of COVID-19

  12 months

• 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

  6 months

• 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.

  12 months

Secondary Outcomes (16)

• Rate of stroke at 6-months follow up

  6 months

• Rate of stroke at 12-months follow up

  12 months

• Rate of death at 6-months follow-up

  6 months

• Rate of death at 12-months follow-up

  12 months

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

  6 months

Study Arms (2)

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

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

Interventions

Observation OTHER

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.

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• If still alive, no willingness and ability to participate in all follow-up examinations.
• Sub cohort 2:
• 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.
• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead
• University Hospital, Akershus: collaborator
• Haukeland University Hospital: collaborator
• Helse Stavanger HF: collaborator
• St. Olavs Hospital: collaborator
• University Hospital of North Norway: collaborator
• Vestre Viken Hospital Trust: collaborator
• Sykehuset Telemark: collaborator
• Sykehuset Innlandet HF: collaborator
• Ostfold Hospital Trust: collaborator
• The Hospital of Vestfold: collaborator
• Sorlandet Hospital HF: collaborator
• Nordlandssykehuset HF: collaborator
• Møre og Romsdal Hospital Trust: collaborator

Study Sites (15)

Sørlandet Hospital Trust

Arendal, Norway

Location

Haukeland University Hospital

Bergen, Norway

Location

Nordlandssykehuset

Bodø, Norway

Location

Vestre Viken Hospital Trust Drammen

Drammen, Norway

Location

Østfold Hospital Trust Kalnes

Grålum, Norway

Location

Sørlandet Hospital Trust, Kristiansand

Kristiansand, Norway

Location

Innlandet Hospital Trust

Lillehammer, Norway

Location

Akershus University Hospital

Lørenskog, Norway

Location

Møre og Romsdal Hospital Trust

Molde, Norway

Location

Oslo University Hospital

Oslo, 0424, Norway

Location

Ostfold Hospital Trust

Sarpsborg, Norway

Location

Skien Hospital

Skien, Norway

Location

Stavanger University Hospital

Stavanger, Norway

Location

University Hospital of North Norway

Tromsø, Norway

Location

St. Olav Hospital

Trondheim, Norway

Location

Related Publications (1)

• 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.

  PMID: 40881041 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Observation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Anne Hege Aamodt, MD, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

• Hanne F Harbo, MD,PhD,Prof

  Oslo University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, MD, PhD

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: October 6, 2020
• Study Start: September 1, 2020
• Primary Completion: May 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NO (15)