PET Imaging of Cyclooxygenase-1 in Participants With Neurological Manifestations of Post-Acute Se… (NCT06920628) | Clinical Trial Compass
RecruitingPhase 1
PET Imaging of Cyclooxygenase-1 in Participants With Neurological Manifestations of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)
United States60 participantsStarted 2025-06-18
Plain-language 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....
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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 participate in this study, healthy volunteers must meet all of the following criteria:
* Aged 18 to 70 years of age.
* Able to provide informed consent.
* Be in good general health, as evidenced by medical history and physical examination, and have no cognitive impairment.
* Does not have an active SARS-CoV-2 infection. The protocol will conform with NIH CC standards for documenting a participant does not have active SARS-CoV-2 infection. This may include screening interviews and/or testing.
*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically looking at brain inflammation in people with neurological symptoms from Long COVID — do my particular symptoms, like brain fog, headaches, or cognitive issues, match what they're studying here?
2The trial uses a PET scan with a radioactive tracer called 11C-PS13 to measure something called cyclooxygenase-1 in the brain — can you explain what that means for my body and whether there are any risks I should know about from the scan or the tracer itself?
3Since this is a Phase 1 trial focused on measuring how the tracer distributes in the brain rather than testing a treatment, would participating actually change my care in any way, or is this purely for research purposes?
4Are there standard treatments or other clinical trials for my Long COVID symptoms that might be worth trying first, before I consider joining a study that is primarily gathering imaging data?
5What would the visit schedule and PET scanning process actually look like day-to-day, and is that realistic given how my Long COVID symptoms currently affect my energy and ability to travel?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.