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

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Dec 16, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how the brain responds to inflammation in people who have had symptoms after getting COVID-19, also known as post-acute sequelae of SARS-CoV-2 (PASC). Researchers will use a special imaging technique called PET (positron emission tomography) to see how a specific substance, labeled DPA-714, is taken up by the brain in individuals with these lingering symptoms compared to healthy individuals. The goal is to better understand the effects of COVID-19 on the brain and how to help those affected.

To be eligible for the study, participants should be between 18 and 65 years old and either have a clinical diagnosis of PASC or be a healthy volunteer with no neurological issues. Participants with PASC must have had COVID-19 and experienced neurological symptoms for at least four weeks. Those interested in joining can expect to undergo imaging procedures, and they will need to meet certain health criteria to ensure their safety during the study. It’s important to note that individuals with certain medical conditions, such as severe chronic diseases or pregnant women, cannot participate.

Gender

ALL

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

Trial Officials