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?

Background: SARS-CoV-2 is the virus that causes COVID-19. Some people who recover from COVID-19 have long-term symptoms that affect the brain. These include headaches; loss of taste and smell; sleep problems; thinking problems; depression; and anxiety. Researchers want to know if a tracer (a substance that is injected into a person s body before an imaging scan) can help identify inflammation in people with these brain disorders. 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. Eligibility: Adults aged 18 to 70 years with post COVID-19 brain disorders who are enrolled in protocol 000089 or 000711. Healthy volunteers are also needed. Design: Participants will have up to 5 clinic visits. Participants will be screened. They will have blood tests and a test of their heart function. They will have imaging scans: Magnetic resonance imaging (MRI): They will lie on a table that slides into a metal tube. Pictures will be taken of the brain. Positron emission tomography (PET): A needle attached to a thin tube will be inserted into a vein in the arm. The tracer will be injected through the tube. Another needle attached to a thin tube will be inserted into the wrist or inside of the elbow of the other arm to draw blood. They will lie still on a bed while a machine captures images of their brain. The scan will last about 2 hours. Study involvement is 11 to 14 weeks....

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.

How does PET imaging differ from other treatments for post-COVID syndrome?

PET imaging is unique because it uses special tracers to visualize metabolic activity in the body, which can help identify inflammation or other changes in tissues that might not be visible with other imaging techniques. This approach is different from standard treatments that typically focus on managing symptoms rather than diagnosing underlying changes. ^{1 2 3 4 5}

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. Germany pubmed.ncbi.nlm.nih.gov

18 F-Fluorodeoxy Glucose and 11 C-Methionine Accumulation in Demyelinating Lesions. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Pitfalls in radiation oncology. "Myocardial metastasis" in PET-CT after palliative radiation treatment of the left 5th rib. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Usefulness of carbon-11-labeled methionine positron-emission tomography for assessing the treatment response of primary central nervous system lymphoma. [2020]

4. India pubmed.ncbi.nlm.nih.gov

Tumefactive Demyelination versus Primary Central Nervous System Lymphoma on 18F-Fluorodeoxyglucose Positron Emission Tomography Magnetic Resonance Imaging: A Twist in the Tale. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Amino Acid Uptake, Glucose Metabolism, and Neuroinflammation in John Cunningham Virus Associated Progressive Multifocal Leukoencephalopathy. [2023]