PET Imaging of Cyclooxygenase-1 in Participants With Neurological Manifestations of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)
National Institute of Mental Health (NIMH)
Summary
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....
Description
Study Description: This study will examine whether cyclooxygenase-1 (COX-1), a biomarker of neuroinflammation, is elevated in the brains of individuals with neurological manifestations of Post-Acute Sequelae of SARS-CoV-2 infection (Neuro-PASC). Objectives: Primary Objective 1: To determine whether COX-1 is elevated in the striatum of individuals with Neuro-PASC compared to an ageand sex-matched group of healthy volunteers. Primary Objective 2: To assess the effect of IVIg treatment on Neuro-PASC participants. Secondary Objective 1: To determine if COX-1 is elevated in all brain regions o…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- Yes
* INCLUSION CRITERIA: Patients: To be eligible for this study, Neuro-PASC participants must meet all of the following criteria: * Aged 18 to 70 years of age. * Participants must be in good general health as evidenced by medical history and physical examination. * Each participant must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document. * Participants must have undergone a screening assessment under protocol #000089, Natural History of Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health or #…
Interventions
- Drug11C-PS13
Injected IV followed by PET scanning.
Location
- National Institutes of Health Clinical CenterBethesda, Maryland