"Long COVID-19" on the Human Brain
1 other identifier
observational
48
1 country
1
Brief Summary
Over one million Canadians have been infected by COVID-19. Many people who have been infected by COVID-19 experience negative mental symptoms, such as "brain fog" and fatigue. For many of these people, they continue to feel these negative mental symptoms even after recovering from COVID-19. However, scientists still do not know how COVID-19 harms the human brain and causes these mental problems. Our goal is to use advanced brain imaging to determine whether people who have been infected with COVID-19 show damage in their brain. We hope that this information will help doctors determine what treatments should be provided to help people who are suffering from continuing mental problems after being infected with COVID-19.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2022
CompletedFirst Posted
Study publicly available on registry
June 27, 2022
CompletedStudy Start
First participant enrolled
August 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 5, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 5, 2024
CompletedMarch 28, 2025
March 1, 2025
2.3 years
June 23, 2022
March 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Synaptic Density (PET Scan)
\[18F\]SDM-8's regional binding potential non-displaceable (BPND) will be calculated using the simplified reference tissue model (SRTM) (31) using as reference the centrum semiovale (32). The PET data will be analyzed using both a priori regions of interest and exploratory whole-brain voxel-based analysis method.
At baseline
Presence and Severity of CNS and PASC Symptoms
A Likert-type scale of the most common COVID-19 sequela symptoms will be employed. The "Long COVID-19 Symptom Assessment" self-report consists of 46 common COVID-19 sequela symptoms, both neurological and non-neurological.
At screening, baseline and at 3-month follow-up
Secondary Outcomes (3)
Changes in Quality of Life
At baseline and at 3-month follow-up
Cognitive, Emotional, Motor and Sensation Measures
At baseline and at 3-month follow-up
Biomarker Measures
At screening, baseline and at 3-month follow-up
Study Arms (3)
Group A
Persons previously infected with COVID-19 experiencing CNS-PASC within 6 months of recovery
Group B
Persons previously infected with COVID-19 without CNS-PASC symptoms within 6 months of recovery
Group C
A control group of persons not previously infected with COVID-19.
Interventions
All groups will undergo cognitive tests and brain imaging scans (MRI \& PET)
Eligibility Criteria
Individuals with or without prior infection with COVID-19
You may qualify if:
- Persons of all races, ethnicities, genders, and sex.
- years of age or older.
- Fully vaccinated for COVID-19 with authorized vaccines in Canada.
- Previously infected with mild-moderate COVID-19 (i.e., out-patients never hospitalized for COVID-19), as confirmed by review of clinical history.
- Not currently infected with SARS-COV-2, as confirmed by COVID-19 Rapid Antigen Test (RAT).
- Additionally, participants enrolled as part of the CNS-PASC group (Group A), must also:
- \. Currently experience CNS-PASC symptoms, not present prior to infection, as confirmed by the "Long COVID-19 Symptom Assessment" scale.
You may not qualify if:
- Participants will be excluded if they meet ANY of the criteria listed below:
- Unstable medical conditions and/or active uncontrolled autoimmune or inflammatory conditions.
- Neurological conditions and/or concussion present prior to COVID-19 infection.
- Substance abuse disorder (except caffeine, nicotine, and cannabis/marijuana) within 6 months of entering the study, as determined by the Structured Clinical Interview (37)
- Positive urine drug screen for drugs of abuse at the screening visit (except for cannabis/marijuana).
- Pregnancy (Note: Females up to age 65 must have negative urine pregnancy test at screening), or breastfeeding.
- Score \<32 on the Wide Range Achievement Test-III.
- Receiving treatment with medications such as levetiracetam that blocks SV2a binding.
- Pacemakers, metallic cardiac valves, magnetic material such as surgical clips, implanted electronic infusion pumps or any other conditions that would preclude the MRI scan.
- Body size/weight above the limits for PET and MRI scanners.
- Exceeding allowed annual radiation exposure levels for research scans of 20 mSv in the past 12 months as outlined by our PET Centre guidelines.
- Having completed multiple PET scans in the past, such that participation in this study would cause participant to exceed lifetime limit (8 PET scans).
- Currently receiving active treatment for cancer.
- Claustrophobia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre for Addiction and Mental Health
Toronto, Ontario, M5T1R8, Canada
Related Links
Biospecimen
Whole blood and nasopharyngeal samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ariel Graff, MD, PhD
Centre for Addiction and Mental Health
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2022
First Posted
June 27, 2022
Study Start
August 5, 2022
Primary Completion
November 5, 2024
Study Completion
November 5, 2024
Last Updated
March 28, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share