PET Imaging of Cyclooxygenase-1 in Participants With Neurological Manifestations of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
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⁃ 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.

• Participants must be at least six weeks out since the onset of SARS-CoV-2 symptoms with no fever for at least one week.

• Participants must report having at least one prior SARS-CoV-2 infection.

• Be enrolled in 01M0254, The Evaluation of Participants with Mood and Anxiety Disorders and Healthy Volunteers or 17M0181, Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies .

• 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.

• Agree to adhere to the lifestyle considerations.

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Tara N Turon, C.R.N.P.
tara.turon@nih.gov
(301) 827-6599
Backup
Robert B Innis, M.D.
robert.innis@nih.gov
(301) 594-1368
Time Frame
Start Date: 2025-06-18
Estimated Completion Date: 2029-02-22
Participants
Target number of participants: 60
Treatments
Other: one arm
All subjects will receive the same tests
Related Therapeutic Areas
Sponsors
Leads: National Institute of Mental Health (NIMH)

This content was sourced from clinicaltrials.gov