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Recruiting EARLY_Phase 1 NCT07076862

Multiparametric [18F]F-AraG Imaging in Post-Acute Sequelae of COVID-19 (PASC)

Trial Parameters

Condition PASC Post Acute Sequelae of COVID-19
Sponsor University of California, Davis
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 51
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-12-04
Completion 2028-12
Interventions
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)

Brief 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.

Eligibility Criteria

Inclusion Criteria: 1. Age ≥ 18 years 2. Ability to understand the purposes and risks of the trial and willingness to sign an IRB-approved informed consent form. 3. Willingness and ability to comply with all protocol required procedures. 4. 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. 5. 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 F

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