Imaging neuroinflammation in patients with neurological issues after COVID-19 infection
PET Imaging of Neuroinflammation in Patients With Neurological Dysfunction After SARS-CoV-2 Infection
This study is testing a special imaging method to see if there is inflammation in the brains of people who have long-term symptoms after COVID-19, compared to healthy volunteers.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT05656105 on ClinicalTrials.gov |
What this trial studies
This clinical imaging study aims to visualize and quantify neuroinflammation in individuals suffering from post-acute sequelae of SARS-CoV-2 (PASC) using a specialized PET imaging agent, Fluorodeoxyglucose(18F)-labeled DPA-714. Participants will include both individuals with a clinical diagnosis of PASC and healthy volunteers for comparison. The study will assess the brain uptake of DPA-714 to better understand the neurological effects of COVID-19. The research is designed to provide insights into the neuroinflammatory processes associated with long-term COVID-19 symptoms.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18 to 65 with a clinical diagnosis of post-acute sequelae of SARS-CoV-2 or healthy volunteers without neurological symptoms.
Not a fit: Patients with contraindications to MRI, severe medical conditions preventing participation, or those with chronic infectious diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of neuroinflammation in post-COVID-19 patients, potentially leading to improved treatment strategies.
How similar studies have performed: While this approach is relatively novel, similar imaging studies have shown promise in understanding neuroinflammation in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama
- UAB — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Jonathan McConathy, MD, PhD — University of Alabama at Birmingham
- Study coordinator: April Riddle
- Email: RadiologyCRC@uabmc.edu
- Phone: 205-9961082
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.