NCT06920628 PET Imaging of Cyclooxygenase-1 in Participants With Neurological Manifestations of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)
| NCT ID | NCT06920628 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | National Institute of Mental Health (NIMH) |
| Condition | Long COVID |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-06-18 |
| Primary Completion | 2028-02-22 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief 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....
Eligibility Criteria
* 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 #000711 Immunotherapy for Neurological Post-Acute Sequelae of SARSCoV-2 (INPASC) and determined to have neuro-PASC. * Participants 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. * Participants must agree to adhere to the lifestyle considerations. Healthy Volunteers: To be eligible to pa
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.