About this trial
This study uses total-body \[¹⁸F\]F-AraG PET/CT imaging to investigate immune activation and vascular changes in individuals with post-acute sequelae of SARS-CoV-2 infection (PASC), also known as Long COVID. Participants will undergo dynamic PET/CT imaging along with blood biomarker assessments and symptom evaluations. The study aims to characterize sites of immunological perturbation, correlate PET imaging findings with peripheral blood markers, and evaluate longitudinal changes in tissue-based immune activity in relation to symptom patterns over time. Data from this study will improve understanding of tissue-level immune dysregulation in PASC and support future clinical tools for assessing and managing this condition.
Eligibility criteria
Qualifiers
Age ≥ 18 years
Ability to understand the purposes and risks of the trial and willingness to sign an IRB-approved informed consent form.
Willingness and ability to comply with all protocol required procedures.
For participants of reproductive potential, defined as individuals who have not been post-menopausal for at least 24 consecutive months (i.e., who have had menses within the preceding 24 months), or women who have not undergone surgical sterilization, specifically hysterectomy and/or bilateral oophorectomy or bilateral salpingectomy, willingness to use effective double barrier contraceptive methods (excluding withdrawal or timing methods) during the study and up to 1 day after the last administration of the radiotracer.
Disqualifiers
Serious comorbidities (nonmalignant disease or other conditions) that in the opinion of the investigator could compromise protocol objectives.
Any condition that alters the function of their immune system or any conditions caused by malfunction of their immune system and would interfere with imaging, including known underlying inflammatory or immune disorders, systemic malignancy, or other chronic viral infections (such as HIV, hepatitis B and hepatitis C).
Received vaccination of any type, including a SARS-CoV-2 vaccine, within 30 days of imaging
Pregnant or nursing individuals. A urine or HCG serum pregnancy test with a sensitivity of at least 25 mIU/mL will be performed at screening and on the day of PET/CT imaging at no charge to all participants of reproductive potential (see definition above).
Trial design
Treatments tested in this trial
- A.1 - [¹⁸F]F-AraG PET/CT (90-min dynamic + 4-h static)
- A.2 - [¹⁸F]F-AraG PET/CT (60-min dynamic only)
- B.1 - [¹⁸F]F-AraG PET/CT (90-min dynamic + 4-h static)
- B.2 - [¹⁸F]F-AraG PET/CT (60-min dynamic only)
Treatment groups
Sponsors and collaborators
University of California, Davis
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
University of California, San Francisco
Collaborator