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Long-term Effects of SARS-CoV-2 on the Central Nervous System and One-year Follow-up of "Long COVID-19" Patients

Primary Purpose

Long Covid19

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Perfusion brain scintigraphy imaging
Sponsored by
Brugmann University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Long Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years;
  • Physically and mentally able to fill out questionnaires;
  • Suspicion and/or confirmation of COVID-19 infection, managed on an out- or inpatient (COVID-19 ward or ICU) basis;
  • Residual symptoms at 8 weeks or more after initial SARS-CoV-2 infection.

Exclusion Criteria:

  • Diagnosed with a neurological syndrome e.g. Parkinson disease, Alzheimer disease, … before SARS-CoV-2 infection;
  • Known Dementia or mild cognitive impairment before SARS-CoV-2.

Sites / Locations

  • CHU BrugmannRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Long Covid19 patient group

Arm Description

Patients with Long Covid19 undergoing perfusion brain scintigraphy

Outcomes

Primary Outcome Measures

Difference (1 year versus baseline) in the distribution of hypo-perfused areas in the brain as assessed by cerebral perfusion scintigraphy.
SPECT data were acquired using a standardized protocol. For focal abnormalities of increased or decreased uptake, the anatomical location was described.

Secondary Outcome Measures

Full Information

First Posted
August 2, 2022
Last Updated
August 3, 2022
Sponsor
Brugmann University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05492292
Brief Title
Long-term Effects of SARS-CoV-2 on the Central Nervous System and One-year Follow-up of "Long COVID-19" Patients
Official Title
Long-term Effects of SARS-CoV-2 on the Central Nervous System and One-year Follow-up of "Long COVID-19" Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brugmann University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the seventh coronavirus known to infect humans, and causing coronavirus disease 2019 (COVID-19). . Since its emergence in December 2019, in Wuhan, China, SARS-CoV-2 has led to a global pandemic with almost 188 million cases and 4 million COVID-19 related deaths reported. Although initially considered as a predominantly acute respiratory illness, it soon became apparent that COVID-19 could also produce neurological manifestations and severe neurological complications. During the acute phase of SARS-CoV-2 infection, about 36% of cases develop neurological symptoms of which 25% can be attributed to the direct involvement of the central nervous system. There are increasing reports of central and peripheral nervous system involvement. Acute neurological manifestations reported, include, but are not limited to: anosmia, dysgeusia, stroke, encephalomyelitis, meningo-encephalitis, posterior reversible encephalopathy, acute necrotizing encephalopathy, new onset seizures and Guillain-Barre syndrome. However, one of the most perplexing aspects of SARS-CoV-2 is that two to four months after their initial (mostly apparently mild) infection, some COVID-19 patients still present a constellation of more chronic neurological symptoms colloquially known as "long COVID-19" syndrome. In these patients, COVID-19 appears to affect long-term brain function and patients have functional complaints as dyspnea, hyposmia/anosmia, dysgeusia/ageusia, but also, and more importantly, memory and cognitive impairment, pain, deadening fatigue, and alterations in sleeping-pattern/insomnia, all of them correlated with typical 18F-FDG brain PET scan abnormalities. At the beginning of the pandemic, the medical world was not expecting the phenomenon of COVID-19 patients developing persistent neurologically symptoms. However, more than one year after the pandemic, multiple waves of the "long COVID-19" syndrome may be expected to occur worldwide. To face the long tail impact of the COVID-19 pandemic on public health and its social and economic consequences on our society, future research urgently needs to be dedicated to these "long COVID-19" patients in an attempt to determine, understand and manage their symptoms. A lot of "long COVID-19" patients are desperately searching for help. This project found his origin in the fact that suddenly many patients spontaneously presented with a similar constellation of persistent (chronic) symptoms, months after they had (mostly mild) COVID-19, with many of them being relatively young, without underlying health problems, but unable to work due to cognitive impairment. During the entire study, the opinion and feelings of these patients will be taken in account, all the more so because the majority of these patients were initially left behind. The primary objective of this study is to determine the different types of neurological dysfunction and clinical manifestations of the "long COVID-19" syndrome and to correlate them to abnormalities/signs on cerebral perfusion scintigraphy. Furthermore, the investigators aim to determine and validate a specific imaging biomarker of post-COVID-19 encephalopathy. The secondary objective of this study is to determine the best therapeutic modality to treat and improve prognosis of patients with "long COVID-19" syndrome with defined central nervous system impairment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Long Covid19

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Long Covid19 patient group
Arm Type
Experimental
Arm Description
Patients with Long Covid19 undergoing perfusion brain scintigraphy
Intervention Type
Diagnostic Test
Intervention Name(s)
Perfusion brain scintigraphy imaging
Intervention Description
The cerebral perfusion scintigraphy via a SPECT examination aims to analyze the cerebral blood flow and detect possible lesions or inflammations.
Primary Outcome Measure Information:
Title
Difference (1 year versus baseline) in the distribution of hypo-perfused areas in the brain as assessed by cerebral perfusion scintigraphy.
Description
SPECT data were acquired using a standardized protocol. For focal abnormalities of increased or decreased uptake, the anatomical location was described.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years; Physically and mentally able to fill out questionnaires; Suspicion and/or confirmation of COVID-19 infection, managed on an out- or inpatient (COVID-19 ward or ICU) basis; Residual symptoms at 8 weeks or more after initial SARS-CoV-2 infection. Exclusion Criteria: Diagnosed with a neurological syndrome e.g. Parkinson disease, Alzheimer disease, … before SARS-CoV-2 infection; Known Dementia or mild cognitive impairment before SARS-CoV-2.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Dominique Gazagnes
Phone
3224773462
Email
MarieDominique.GAZAGNES@chu-brugmann.be
First Name & Middle Initial & Last Name or Official Title & Degree
Tatiana Besse-Hammer
Phone
3224773312
Email
tatiana.besse-hammer@chu-brugmann.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Dominique Gazagnes
Organizational Affiliation
CHU Brugmann
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Brugmann
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Dominique GAZAGNES, MD

12. IPD Sharing Statement

Learn more about this trial

Long-term Effects of SARS-CoV-2 on the Central Nervous System and One-year Follow-up of "Long COVID-19" Patients

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