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

NCT05656105 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: R22-209
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

SARS CoV-2 Post-Acute Sequelae

Outcome Measures

Primary Outcomes (1)

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

  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

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

Study Arms (2)

Healty Volunteers

EXPERIMENTAL

Drug: DPA-714 PET/MRI

PASC

EXPERIMENTAL

Patients meeting the case definition criteria for PASC

Drug: DPA-714 PET/MRI

Interventions

DPA-714 PET/MRI DRUG

DPA-714 PET/MRI

Healty Volunteers; PASC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.
• Currently 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB

Birmingham, Alabama, 35249, United States

RECRUITING

Study Officials

• Jonathan McConathy, MD, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

April Riddle

CONTACT

205-9961082; RadiologyCRC@uabmc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. P.h.D., Director for the Division Molecular Imaging and Therapeutics

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 19, 2022
• Study Start: November 10, 2023
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)