PET Imaging for Post-COVID Syndrome

Overseen By Robert B Innis, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Institute of Mental Health (NIMH)

Must not be taking: NSAIDs, Aspirin, Corticosteroids, Immunosuppressants

Disqualifiers: Substance use disorder, Unstable medical condition, Pregnancy, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 4-6 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special tracer used in PET scans can detect brain inflammation in people who continue to have brain-related symptoms after recovering from COVID-19, such as headaches and difficulty thinking. The tracer, called \[11C\]PS13, is injected before imaging to highlight areas of inflammation. Ideal participants have experienced ongoing brain issues after COVID-19 and are part of specific ongoing studies. Additionally, healthy volunteers with no cognitive issues are needed. Participants will undergo several imaging tests over 11 to 14 weeks. As a Phase 1 trial, this research focuses on understanding how the tracer works in people, offering participants a chance to contribute to groundbreaking insights into post-COVID-19 brain health.

Will I have to stop taking my current medications?

You may need to stop taking certain medications like NSAIDs, aspirin, corticosteroids, or immunosuppressants before the PET scan. NSAIDs should not be taken for two weeks prior, and aspirin, corticosteroids, or immunosuppressants should not be taken for a month before the scan.

What prior data suggests that this tracer is safe for humans?

Research has shown that 11C-PS13 is generally safe for humans. This radioactive tracer safely measures brain inflammation. It has been tested in various conditions, such as eye inflammation and post-COVID syndrome, with manageable side effects. Although this trial is in an early stage, requiring more safety data, earlier studies in humans provide some reassurance about its safety. Joining a clinical trial is a personal choice, and discussing concerns with a healthcare provider can be helpful. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using 11C-PS13 PET imaging for post-COVID syndrome because it offers a new way to visualize inflammation in the brain. While current treatments for post-COVID syndrome focus on managing symptoms like fatigue and cognitive issues, 11C-PS13 targets a specific protein linked to inflammation, potentially allowing doctors to see the underlying causes of these symptoms. This innovative approach could lead to more precise and effective treatments by understanding the condition at a deeper level, beyond just symptom management.

What evidence suggests that this tracer is effective for identifying brain inflammation in post-COVID syndrome?

Research shows that the radioactive tracer [11C]PS13 might help spot brain inflammation by highlighting affected areas after COVID-19. Studies have found that this tracer targets an enzyme called cyclooxygenase-1 (COX-1), which links to inflammation. Using PET scans, [11C]PS13 can reveal inflammation patterns in the brain. This method could aid in understanding and possibly managing ongoing symptoms of post-COVID brain conditions. Although research continues, these findings suggest that [11C]PS13 could be a helpful tool in detecting brain inflammation in people with post-COVID symptoms. ^{1 2 3 6 7}

Who Is on the Research Team?

Robert B Innis, M.D.

Principal Investigator

National Institute of Mental Health (NIMH)

Are You a Good Fit for This Trial?

Adults aged 18-70 with long-term brain-related symptoms after COVID-19, who've been screened under specific NIH protocols. They must be in good health, understand the study and consent to it, have no metal in their wrists, adhere to lifestyle requirements, not currently infected with SARS-CoV-2, and be at least six weeks out from initial COVID symptoms.

Inclusion Criteria

Healthy volunteers must have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists

Healthy volunteers must agree to adhere to the lifestyle considerations

Healthy volunteers must report having at least one prior SARS-CoV-2 infection

Exclusion Criteria

I am healthy and have taken NSAIDs within the last two weeks.

Participants with Neuro-PASC who have substance use disorder or alcohol use disorder

Participants with Neuro-PASC who are unable to have an MRI scan

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Imaging

Participants undergo MRI and PET scans to assess brain inflammation

1-2 weeks

2 visits (in-person)

Treatment

Participants may receive IVIg treatment and undergo a second scan to assess COX-1 expression

4-6 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging and treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• 11C-PS13

Trial Overview The trial is testing a radioactive tracer called [11C]PS13 during PET scans to see if it can show inflammation in the brains of people with neurological issues post-COVID. Participants will also undergo MRI scans and other assessments over an 11-to-14-week period.

How Is the Trial Designed?

Group I: one arm Experimental Treatment 1 Intervention

All subjects will receive the same tests

Who Is Running the Clinical Trial?

National Institute of Mental Health (NIMH)

Lead Sponsor

Trials

3,007

Recruited

2,852,000+

Citations

1. longcovidstudies.net longcovidstudies.net/

Long Covid Studies: Home A Study to Examine Anktiva for the Treatment of COVID-19. This study will examine the safety and effectiveness of Anktiva in treating patients with Long COVID..

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06920628?term=AREA%5BConditionSearch%5D(COVID-19)%20AND%20AREA%5BBasicSearch%5D(mental,%20depression,%20anxiety)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING)%20AND%20AREA%5BFunderTypeSearch%5D(NIH)&rank=8

PET Imaging of Cyclooxygenase-1 in Participants With ... To see if a radioactive tracer ([11C]PS13) can highlight brain inflammation in those who had COVID-19 but still have symptoms that affect the brain. Eligibility ...

3. withpower.com withpower.com/trial/phase-1-covid-19-3-2025-27635

PET Imaging for Post-COVID Syndrome Objective:To see if a radioactive tracer (\[11C\]PS13) can highlight brain inflammation in those who had COVID-19 but still have symptoms that affect the brain.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9841251/

Whole-Body PET Imaging in Humans Shows That 11C-PS13 ... 11 C-PS13 might be used to image COX-1 as a surrogate marker for the development and progression of diseases marked by inflammation and measure the target ...

5. ucdavis.edu ucdavis.edu/news/total-body-pet-imaging-takes-look-long-covid

Total-Body PET Imaging Takes a Look at Long COVID Using total-body PET imaging to get a better understanding of long COVID disease is the goal of a new project at the University of ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35798558/

Whole-Body PET Imaging in Humans Shows That 11 C-PS13 ... This study sought to evaluate the selectivity of 11C-PS13 binding to COX-1 in humans and assess the utility of 11C-PS13 to measure the in vivo ...

7. malacards.org malacards.org/card/long_covid

Long Covid Long COVID, also known as long-haul COVID or Post-COVID Conditions (PCC), is a chronic condition that can develop after an initial COVID-19 infection.