Status:
COMPLETED
"Long COVID-19" on the Human Brain
Lead Sponsor:
Centre for Addiction and Mental Health
Collaborating Sponsors:
Sunnybrook Health Sciences Centre
Conditions:
COVID-19
Long Covid
Eligibility:
All Genders
18+ years
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...
Detailed Description
This is a cross-sectional study composed of three participant groups. 1) persons previously infected with COVID-19 experiencing CNS-PASC (central nervous system Post-Acute Sequelae of COVID-19) within...
Eligibility Criteria
Inclusion
- Persons of all races, ethnicities, genders, and sex.
- 18 years of age or older.
- Fully vaccinated for COVID-19 with authorized vaccines in Canada.
- Participants in COVID-19 groups (Group A and B) will have the following additional inclusion criteria:
- 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:
- 1\. Currently experience CNS-PASC symptoms, not present prior to infection, as confirmed by the "Long COVID-19 Symptom Assessment" scale.
Exclusion
- 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.
Key Trial Info
Start Date :
August 5 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 5 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05433324
Start Date
August 5 2022
End Date
November 5 2024
Last Update
March 28 2025
Active Locations (1)
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1
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T1R8