Neurological Outcome After SARS-CoV-2 Infection

SARS-CoV-2 Clinical Trial

— ATTRACT  

Official title:

Long-term Neurological Outcome After SARS-CoV-2 Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05025839
• Other study ID #: KLI 986
• Status: Recruiting
• Start date: April 7, 2021
• Est. completion date: September 1, 2024

Study information

• Verified date: August 2021
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Wider research context: Since the recognition of SARS-CoV-2 outbreak in 2019, there are now over 126 million COVID-19 cases worldwide with more than 2.7 million deaths. Reports on neurological manifestations vary in prevalence rates (6-84%) and range from mild (headache, hyposmia, myalgia) to severe (encephalopathy, strokes, seizures). Little is known about long-term neurological outcomes of COVID-19 patients. The investigators propose a structured protocol to capture persistent and delayed neurological manifestations, neurocognitive deficits and quality of life (QoL) 3 and 12 months after COVID-19. Objectives: The investigators hypothesize that neurological manifestations and neuropsychological/cognitive deficits can be detected after COVID-19, substantially impact on patients' QoL and can be correlated with structural neuroimaging findings. Main objectives are to assess firstly long-term prevalence rates and natural history of neurological manifestations, secondly neuropsychological/cognitive deficits after COVID-19, thirdly the impact of COVID-19 on measures of mental health, QoL and functional outcome, fourthly to correlate neurological manifestations and distinct neurocognitive deficits with structural MRI abnormalities, and Fifthly to compare these results to age- and sex matched controls hospitalized with pneumonia (Cpneum) and to healthy controls for MRI-data (Chealthy). Approach: The investigators aim to enrol at least 225 patients with COVID-19, in addition to 50 Cpneum and 80 Chealthy. COVID-19 patients will include (group Oóne) outpatients presenting to the hospital, (group two) in-patients not requiring ICU admission, and (group three) patients admitted to the ICU. The investigators will not include asymptomatic patients, patients not presenting to the hospital, and those who do not consent to participate. The standardized protocol includes a firstly a structured neurological examination, secondly olfactory testing, thirdly assessment of QoL, mental health and functional outcome at 3 and 12 months, and fourthly screening for cognitive deficits (at 3 months) and a structured neuropsychological testing (at 12 months) in COVID-19 patients and controls. In a subset of at least 120 COVID-19 patients and 50 controls (Cpneum) high field MRI will be performed at 3 and 12 months. Innovation: The investigators aim to quantify COVID-19 related and specific neurological manifestations and their impact on the individual health condition. The novelty lies in the prospective design, the longitudinal follow-up including and the inclusion of a control group which allows us to explore the natural history of COVID-19 related neurological manifestations. Preliminary analysis of our ongoing 3-month follow-up suggests persistent neurological manifestations 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 of COVID-19 patients and help to identify those, who need further neuro-rehabilitative support

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 355
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infection
• SARS-CoV-2

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University Innsbruck, Department of Neurology	Innsbruck	Tyrol

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of neurological manifestations in COVID-19 patients	3-month prevalence of neurological manifestations in COVID-19 patients presenting to the hospital in comparison to control patients (Cpneum)	3-months
Primary	Prevalence of neurological manifestations in COVID-19 patients	12-month prevalence of neurological manifestations in COVID-19 patients presenting to the hospital in comparison to control patients (Cpneum)	12-months
Secondary	Association, prevalence and classification of neurologic manifestations with structural neuroimaging in hospitalised COVID-19 patients after 3-months.	Association of neurologic manifestations (specifically neuropsychological deficits and smelling deficits) with structural neuroimaging (high-field MRI) in comparison to control patients (Cpneum). Prevalence and classification of neuroimaging abnormalities in hospitalized COVID-19 patients in comparison to controls (Cpneum and Chealthy). Other (exploratory) endpoints derived from the clinical database might be analyzed on data driven considerations 3-months after acute disease.	3-months
Secondary	Association, prevalence and classification of neurologic manifestations with structural neuroimaging in hospitalised COVID-19 patients after 12-months.	Association of neurologic manifestations (specifically neuropsychological deficits and smelling deficits) with structural neuroimaging (high-field MRI) in comparison to control patients (Cpneum). Prevalence and classification of neuroimaging abnormalities in hospitalized COVID-19 patients in comparison to controls (Cpneum and Chealthy). Other (exploratory) endpoints derived from the clinical database might be analyzed on data driven considerations 12-months after acute disease.	12-months