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NCT Number: NCT05656105

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

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

UAB

Birmingham, Alabama, 35249, United States

Location status: Recruiting

Location contact

April Riddle

CONTACT

[email protected]

2059961082

Jonathan McConathy, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 to 65 years of age
  • Healthy volunteer OR Clinical diagnosis of post-acute sequelae of SARS-CoV-2 (PASC)
  • High or mixed affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971.
  • 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.
  • Healthy control participants must have no neurological symptoms

Exclusion criteria

  • Contraindication to MRI
  • Pregnancy
  • Lactation
  • Individuals who are unable to participate in the imaging portion due to severity of their medical condition
  • Chronic infectious disease (e.g. HIV, HCV)
  • Viral or bacterial illness requiring medical attention and/or antibiotics within 1 month of study participation
  • Diagnosis of cancer, including leukemia
  • Blood or blood clotting disorder
  • Except for individuals with Multiple Sclerosis (MS), a diagnosis of autoimmune disease is exclusionary
  • 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:

  • 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

Treatment and study plan

DPA-714 PET/MRI

Drug

DPA-714 PET/MRI

Primary outcomes

  1. Measurement of regional brain TSPO levels using PET in participants with neurological PASC and healthy volunteers

    Time frame: Injection/scan date to clinical follow-up. (Usually within 6 weeks)

    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

Study contacts

Contact information is provided by the study sponsor or research team.

April Riddle

CONTACT

[email protected]

205-9961082

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Dec 19, 2022
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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