NCT06920628

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: National Institute of Mental Health (NIMH) · NIH
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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....

Detailed 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 of individuals with Neuro-PASC compared to healthy volunteers. Secondary Objective 2: To determine the correlation between COX-1 expression in the striatum of Neuro-PASC participants and three variables: a) plasma CRP levels as an overall measure of inflammation, b) speed on the finger-tapping test, and c) clinical improvement. Endpoints: Primary endpoints: * COX-1 binding in the striatal region (i.e., caudate plus putamen) will be quantified using pharmacokinetic modeling to compare striatal COX-1 in the Neuro-PASC participants to healthy volunteers * Neuro-PASC participants will be separated into responders and non-responders to the IVIg treatment and scanned a second time to assess COX-1 expression. Secondary endpoints: * Comparison of the whole brain COX-1 densities at the voxel level between the Neuro-PASC participants and healthy volunteers. * COX-1 striatal expression relation to Neuro-PASC participants plasma CRP levels, speed on the finger-tapping test, and clinical improvement.

Conditions

• Long COVID
• Post Acute Sequelae of COVID-19

Interventions

Type	Name	Description
DRUG	11C-PS13	Injected IV followed by PET scanning.

Timeline

• Start date: 2025-06-18
• Primary completion: 2028-02-22
• Completion: 2029-02-22
• First posted: 2025-04-10
• Last updated: 2026-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study