RecruitingEarly Phase 1

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

United States60 participantsStarted 2023-11-10

Plain-language summary

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.

Who can participate

Age range18 Years – 65 Years

SexALL

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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

What they're measuring

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

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

Trial details

NCT IDNCT05656105

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06-01

Contact for this trial

April Riddle

205-9961082 RadiologyCRC@uabmc.edu

View on ClinicalTrials.gov More SARS CoV-2 Post-Acute Sequelae trials