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

Phase 1

Recruiting

• Conditions: Long COVID; Post Acute Sequelae of COVID-19
• Interventions: Drug: 11C-PS13

• Registration Number: NCT06920628
• Lead Sponsor: National Institute of Mental Health (NIMH)

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....

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.

Study Timeline

• Study First Submitted: 2025-04-09
• Study First Submitted QC: 2025-04-09
• Study First Posted: 2025-04-10
• Status Verified: 2025-05-12
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-21
• Study Start: 2025-05-26
• Primary Completion: 2028-02-22
• Study Completion: 2029-02-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
one arm	11C-PS13	All subjects will receive the same tests

Primary Outcome Measures

Name	Time	Method
To measure distribution volume for 11C-PS13	36 months	Target quantification of COX-1

Secondary Outcome Measures

Name	Time	Method
Voxel-wise correlation of distribution volume between healthy volunteers and Neuro-PASC participants	36 months	Comparing between COX-1 in healthy volunteers and participants on voxel-level
Correlation of Distribution Volume with CRP	36 months	To determine if CRP correlates with COX-1
Correlation of Distribution Volume with Finger Tapping Speed	36 months	To determine if Finger-tapping correlates with COX-1
Correlation of Distribution Volume with Clinical Improvement	36 months	To determine if Clinical Improvement correlates with COX-1

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States