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....
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 #000711 Immunotherapy for Neurological Post-Acute Sequelae of SARSCoV-2 (INPASC) and determined to have neuro-PASC.
Clinically significant abnormalities on EKG or laboratory testing based on individual clinical judgement. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen). Any lab value that is two times the upper limit or lower values, as per the investigator s judgment. Creatinine level >1.3 mg/dL.
Participants should not have taken Non-Steroidal Anti-Inflammatory Drug (NSAID)s for two weeks prior to each PET scan. Corticosteroids (with the exception of topical steroids), or immunosuppressants (e.g. methotrexate) must not have been taken within one month prior to each PET scan.
Participants must not have substance use disorder or alcohol use disorder. However, alcohol or cannabis use by themselves are not exclusion criteria, unless that use impairs daily life functions.
Participants who have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy).
Single group
11C-PS13
DrugInjected IV followed by PET scanning.
To measure distribution volume for 11C-PS13
Target quantification of COX-1
Voxel-wise correlation of distribution volume between healthy volunteers and Neuro-PASC participants
Comparing between COX-1 in healthy volunteers and participants on voxel-level
Correlation of Distribution Volume with CRP
To determine if CRP correlates with COX-1
Correlation of Distribution Volume with Finger Tapping Speed
To determine if Finger-tapping correlates with COX-1
Correlation of Distribution Volume with Clinical Improvement
To determine if Clinical Improvement correlates with COX-1
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