NCT05433324Completed
"Long COVID-19" on the Human Brain
Source: ClinicalTrials.gov · Last updated 28 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 48 (actual)
- First submitted
- 23 Jun 2022
- Start date
- 5 Aug 2022
- Primary completion date
- 5 Nov 2024
- Lead sponsor
- Centre for Addiction and Mental Health
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT05433324
What you commit to
- Study type: Observational
- Participants enrolled: 48
- From 5 Aug 2022 to the primary completion date, 5 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Neurological conditions and/or concussion present prior to COVID-19 infection.
- Positive urine drug screen for drugs of abuse at the screening visit (except for cannabis/marijuana).
- Receiving treatment with medications such as levetiracetam that blocks SV2a binding.
- Exceeding allowed annual radiation exposure levels for research scans of 20 mSv in the past 12 months as outlined by our PET Centre guidelines.
- Currently receiving active treatment for cancer.
Other illness
- Unstable medical conditions and/or active uncontrolled autoimmune or inflammatory conditions.
- Substance abuse disorder (except caffeine, nicotine, and cannabis/marijuana) within 6 months of entering the study, as determined by the Structured Clinical Interview (37)
- Pacemakers, metallic cardiac valves, magnetic material such as surgical clips, implanted electronic infusion pumps or any other conditions that would preclude the MRI scan.
Age
- Pregnancy (Note: Females up to age 65 must have negative urine pregnancy test at screening), or breastfeeding.
Other
- Participants will be excluded if they meet ANY of the criteria listed below:
- Score \<32 on the Wide Range Achievement Test-III.
- Body size/weight above the limits for PET and MRI scanners.
- Having completed multiple PET scans in the past, such that participation in this study would cause participant to exceed lifetime limit (8 PET scans).
- Claustrophobia.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre for Addiction and Mental Health Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.