Official Title
Long-term Neurological Outcome After SARS-CoV-2 Infection
Brief Summary

Wider research context: Since the recognition of SARS-CoV-2 outbreak in 2019, there arenow over 126 million COVID-19 cases worldwide with more than 2.7 million deaths. Reportson neurological manifestations vary in prevalence rates (6-84%) and range from mild(headache, hyposmia, myalgia) to severe (encephalopathy, strokes, seizures). Little isknown about long-term neurological outcomes of COVID-19 patients. The investigatorspropose a structured protocol to capture persistent and delayed neurologicalmanifestations, neurocognitive deficits and quality of life (QoL) 3 and 12 months afterCOVID-19. Objectives: The investigators hypothesize that neurological manifestations andneuropsychological/cognitive deficits can be detected after COVID-19, substantiallyimpact on patients' QoL and can be correlated with structural neuroimaging findings. Mainobjectives are to assess firstly long-term prevalence rates and natural history ofneurological manifestations, secondly neuropsychological/cognitive deficits afterCOVID-19, thirdly the impact of COVID-19 on measures of mental health, QoL and functionaloutcome, fourthly to correlate neurological manifestations and distinct neurocognitivedeficits with structural MRI abnormalities, and Fifthly to compare these results to age-and sex matched controls hospitalized with pneumonia (Cpneum) and to healthy controls forMRI-data (Chealthy). Approach: The investigators aim to enrol at least 225 patients withCOVID-19, in addition to 50 Cpneum and 80 Chealthy. COVID-19 patients will include (groupOóne) outpatients presenting to the hospital, (group two) in-patients not requiring ICUadmission, and (group three) patients admitted to the ICU. The investigators will notinclude asymptomatic patients, patients not presenting to the hospital, and those who donot consent to participate. The standardized protocol includes a firstly a structuredneurological examination, secondly olfactory testing, thirdly assessment of QoL, mentalhealth and functional outcome at 3 and 12 months, and fourthly screening for cognitivedeficits (at 3 months) and a structured neuropsychological testing (at 12 months) inCOVID-19 patients and controls. In a subset of at least 120 COVID-19 patients and 50controls (Cpneum) high field MRI will be performed at 3 and 12 months. Innovation: Theinvestigators aim to quantify COVID-19 related and specific neurological manifestationsand their impact on the individual health condition. The novelty lies in the prospectivedesign, the longitudinal follow-up including and the inclusion of a control group whichallows us to explore the natural history of COVID-19 related neurological manifestations.Preliminary analysis of our ongoing 3-month follow-up suggests persistent neurologicalmanifestations and a significant impact of COVID-19 on mental health, cognition and QoL.The investigators believe that our study results likely influence the long-term care ofCOVID-19 patients and help to identify those, who need further neuro-rehabilitativesupport

Unknown status
SARS-CoV-2
Post-acute COVID-19 Syndrome

Other: No Intervention

No Intervention takes place, Patients are being observed and classified according to
disease severity
Other Name: Observation

Eligibility Criteria

Inclusion Criteria:

- (1) Patients of either sex, aged ≥18 years with

- (2) confirmed SARS-CoV-2 infection (according to the Austrian Federal Ministry of
Social Affairs, Health, Care and Consumer Protection),

- (3) signed and dated declaration of consent by the patient according to ICH-GCP
Guidelines,

- (4) being able to speak and understand the German language

Exclusion Criteria:

- (1) Pre-existing dementia,

- (2) confirmed pregnancy,

- (3) patients without the capacity to consent,

- (4) asymptomatic patients,

- (5) patients not presenting to the hospital

Specific Inclusion/exclusion criteria for the MRI substudy

Inclusion criteria:

- (1) Patients of either sex, aged ≥18 years with

- (2) confirmed SARS-CoV-2 infection (according to the Austrian Federal Ministry of
Social Affairs, Health, Care and Consumer Protection),

- (3) signed and dated declaration of consent by the patient according to ICH-GCP
Guidelines,

- (4) being able to speak and understand the German language

- (5) agree to participate for MRI

Exclusion criteria:

- (1) Pre-existing dementia,

- (2) confirmed pregnancy,

- (3) patients without the capacity to consent,

- (4) asymptomatic patients,

- (5) patients not presenting to the hospital

- (6) definite contraindication to MRI (e.g. pacemakers)

Controls Patients after pneumonia (Cpneum) We will enrol at least 50 hospitalized age-
and sex matched patients with pneumonia based on disease severity during the acute
disease as: (group One) hospitalized (moderate; n=25) and (group two) severe patients
admitted to the ICU for mechanical ventilation (n=25).

Inclusion criteria:

- (1) Patients of either sex, aged ≥18 years with

- (2) bacterial pneumonia according to CDC criteria,

- (3) signed and dated declaration of consent by the patient according to ICH-GCP
Guidelines, and

- (4) being able to speak and understand the German language,

- (5) agree to participate for MRI

Exclusion criteria:

- (1) Pre-existing dementia,

- (2) confirmed pregnancy,

- (3) patients without the capacity to consent,

- (4) definite contraindication to MRI (e.g. pacemakers)

Healthy referents (Chealthy) Currently n=38 MRI acquisitions of prospectively recruited
healthy individuals are available, fulfilling the criteria of this proposal (age- and sex
matched; same MR protocol). This cohort will be prospectively extended by n=42 to reach
age and sex matched criteria.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 130 Years
Countries
Austria
Locations

Medical University Innsbruck, Department of Neurology
Innsbruck, Tyrol, Austria

Investigator: Raimund Helbok, Priv.Doz. Dr.
Contact: +43 50 504
raimund.helbok@tirol-kliniken.at

Medical University Innsbruck
NCT Number
MeSH Terms
COVID-19
Post-Acute COVID-19 Syndrome