Multiparametric [18F]F-AraG Imaging in Post-Acute Sequelae of COVID-19 (PASC) (NCT07076862) | Clinical Trial Compass
RecruitingEarly Phase 1
Multiparametric [18F]F-AraG Imaging in Post-Acute Sequelae of COVID-19 (PASC)
United States51 participantsStarted 2025-12-04
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Previous diagnosis of SARS-CoV-2 infection as defined by a prior positive SARS-CoV-2 nucleic acid-based diagnostic test performed in a clinical laboratory on one or more nasopharyngeal or respiratory secretion samples or from an FDA-approved rapid antigen test at home. Documentation of the positive test will be requested but not required; if not available the participant will be asked to attest to the presence of a positive test.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quantification of [¹⁸F]F-AraG uptake kinetics in PASC and control participants
Timeframe: Baseline Imaging Visit
2
Correlation between [¹⁸F]F-AraG uptake parameters and blood-based markers of immune dysregulation
Timeframe: Baseline imaging visit and baseline blood draw
3
Longitudinal change in [¹⁸F]F-AraG uptake and correlation with PASC symptom scores
Timeframe: Baseline, 4-month, and 8-month follow-up visits (subset of PASC participants only)
. Onset of COVID-19 symptoms (or if no symptoms, time of initial nucleic acid or antigen-based diagnostic test) at least 3 months prior to the baseline study visit.
. Ability to travel to our research sites in San Francisco and Sacramento.
. Laboratory evaluations obtained within 60 days prior to entry:
Exclusion criteria
. 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).
. Participants who have had prior allogeneic stem cell or solid organ transplant.
. Previously diagnosed myelodysplasia syndrome or history of lymphoproliferative disease prior to study entry.
. Active systemic autoimmune diseases not related to COVID-19.
. Self-reported history of dysphoria or anxiety in closed spaces (i.e., uncontrolled claustrophobia).