Positron Emission Tomography (PET) Imaging of Neuroinflammation in Patients With Neurological Dysfunction After Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2) Infection

PET Imaging of Neuroinflammation in Patients With Neurological Dysfunction After SARS-CoV-2 Infection

This clinical imaging study will use the small molecule translocator protein (TSPO) ligand, Fluorodeoxyglucose(18F)-labeled DPA-714, to visualize and quantify neuroinflammation in individuals with post-acute sequelae of SARS-CoV-2 (PASC) . The brain uptake of DPA-714 will be contrasted with healthy subjects.

Study Overview

• Status: Recruiting
• Conditions: SARS CoV-2 Post-Acute Sequelae
• Intervention / Treatment: Drug: DPA-714 PET/MRI

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: April Riddle; Phone Number: 205-9961082; Email: RadiologyCRC@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • Recruiting
      • UAB
      • Principal Investigator: Jonathan McConathy, MD, PhD
      • Contact: April Riddle; Phone Number: 2059961082; Email: RadiologyCRC@uabmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 18 to 65 years of age
2. Healthy volunteer OR Clinical diagnosis of post-acute sequelae of SARS-CoV-2 (PASC)
3. High or mixed affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971.
4. PASC participants must have been previously infected with SARS-CoV-2. Their neurological symptoms must have been present for at least four weeks prior to the enrollment.
5. Healthy control participants must have no neurological symptoms

Exclusion Criteria:

1. Contraindication to MRI
2. Pregnancy
3. Lactation
4. Individuals who are unable to participate in the imaging portion due to severity of their medical condition
5. Chronic infectious disease (e.g. HIV, HCV)
6. Viral or bacterial illness requiring medical attention and/or antibiotics within 1 month of study participation
7. Diagnosis of cancer, including leukemia
8. Blood or blood clotting disorder
9. Except for individuals with Multiple Sclerosis (MS), a diagnosis of autoimmune disease is exclusionary
10. Positive urine β-hCG test day of procedure or a serum human chorionic gonadotropin (hCG) test within 48 hours prior to the administration of [18F]DPA-714.11.

11Currently enrolled in a clinical trial utilizing experimental therapies. 12. Currently taking experimental therapies 13. Low affinity binder for TSPO ligands based on genotyping for SNP rs6971.

The following exclusionary criteria apply only to PASC patients and healthy controls:

14. Self-reported history of moderate or severe traumatic brain injury 15. Self-reported history of whiplash injury 16. Self-reported history of Inflammatory bowel disease (IBD). (Individuals with Irritable Bowel Syndrome (IBS) and no signs of inflammation will be allowed to participate.) 17. The following blood test results (at screening) will be exclusionary: 18. Rheumatoid Factor (RF) => 14 IntUnits/mL, 19. Anti-nuclear antibody (ANA) > 1:80, 20. Erythrocyte sedimentation rate (ESR) > 60mm/hour, 21.High sensitivity C-reactive protein (hsCRP) > 10mg/L, 22. Complete blood count (CBC) results indicating acute infection, anemia, or other condition, 23. T3, T4, or thyroid-stimulating hormone (TSH) levels out of normal range, 24. Fasting glucose > 100 mg/dL, 25. Blood chemistry results indicating organ damage or other serious medical condition 26. Use of illicit substances within the past 6 months 27. Self-reported diagnosis of Type I or Type II diabetes 28. Healthy controls must not regularly take over-the-counter anti-inflammatory medication, analgesics (except aspirin), or sleep medication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healty Volunteers	Drug: DPA-714 PET/MRI; DPA-714 PET/MRI
Experimental: PASC; Patients meeting the case definition criteria for PASC	Drug: DPA-714 PET/MRI; DPA-714 PET/MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of regional brain TSPO levels using PET in participants with neurological PASC and healthy volunteers	PET measures of TSPO binding in brain regions including cerebral cortex, thalami, and brainstem will be quantified in symptomatic study participants and healthy volunteers will be collected and compared between groups	Injection/scan date to clinical follow-up. (Usually within 6 weeks)

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Jonathan McConathy, MD, PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2023
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: December 8, 2022
• First Submitted That Met QC Criteria: December 16, 2022
• First Posted (Actual): December 19, 2022

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 30, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Inflammation; Neuroinflammatory Diseases
• Other Study ID Numbers: IRB-300010479 R22-209

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No