Neurological Outcome After SARS-CoV-2 Infection

NCT05025839 | Unknown

• 1 other identifier: KLI 986
• Study Type: observational
• Target: 355
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

SARS-CoV-2; Post-acute COVID-19 Syndrome

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Association, prevalence and classification of neurologic manifestations with structural neuroimaging in hospitalised COVID-19 patients after 3-months.

  3-months

• Association, prevalence and classification of neurologic manifestations with structural neuroimaging in hospitalised COVID-19 patients after 12-months.

  12-months

Study Arms (5)

C healthy

Healthy control group

Other: No Intervention

C pneum

Control group of patients who were hospitalised and diagnosed with pneumonia ( COVID-19 pneumonia excluded)

Other: No Intervention

Mild

Outpatients presenting to the hospital with COVID-19

Other: No Intervention

Moderate

In-patients with COVID-19 not requiring ICU admission

Other: No Intervention

Severe

Patients with COVID-19 admitted to the ICU

Other: No Intervention

Interventions

No Intervention OTHER

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

Also known as: Observation

C healthy; C pneum; Mild; Moderate; Severe

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We aim to include a full dataset of at least 180 patients undergoing 3- and 12-month follow-up. Due to an estimated dropout rate of \~20%, approximately 225 patients are planned to be included in 3-month follow-up. Out of these, we estimate to include a minimum of 50 patients in each of the 3 pre-defined groups, which is feasible based on the preliminary analysis of patient distribution: severe patients: 25%, moderate patients: 50% and mild patients: 25%. In addition, we aim to include at least 120 patients in the MRI sub-study. For the control group, we plan to include 50 age- and sex matched patients (n=25 normal ward, n=25 ICU admission) who undergo the same 3- and 12-month study protocol including MR imaging and neurocognitive testing as COVID-19 patients. Out of these, we expect an estimated dropout rate of \~10% at the 12-month follow-up resulting in 40 patients who will completely finish the study protocol.

You may qualify if:

• (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

You may not qualify if:

• (1) Pre-existing dementia,
• (2) confirmed pregnancy,
• (3) patients without the capacity to consent,
• (4) asymptomatic patients,
• (5) patients not presenting to the hospital
• (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
• (1) Pre-existing dementia,
• (2) confirmed pregnancy,
• (3) patients without the capacity to consent,
• (4) asymptomatic patients,
• (5) patients not presenting to the hospital

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Medical University Innsbruck, Department of Neurology

Innsbruck, Tyrol, 6020, Austria

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Observation

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 27, 2021
• Study Start: April 7, 2021
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2024
• Last Updated: August 27, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)