Official Title
PET Imaging of Neuroinflammation in Patients with Neurological Dysfunction After SARS-CoV-2 Infection
Brief Summary

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

Detailed Description

Not Provided

Recruiting
SARS CoV-2 Post-Acute Sequelae

Drug: DPA-714 PET/MRI

DPA-714 PET/MRI

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 65 Years
Countries
United States
Locations

UAB
Birmingham, Alabama, United States

Investigator: April Riddle
Contact: 2059961082
RadiologyCRC@uabmc.edu

Contacts

April Riddle
205-9961082
RadiologyCRC@uabmc.edu

Jonathan McConathy, MD, PhD, Principal Investigator
University of Alabama at Birmingham

University of Alabama at Birmingham
NCT Number
MeSH Terms
Neuroinflammatory Diseases