NCT07076862

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

Multiparametric Total-Body [18F]F-AraG PET/CT Imaging in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Post-acute sequelae of SARS-CoV-2 infection (PASC) is associated with persistent immune dysregulation affecting multiple organ systems. This prospective, non-randomized, open-label research study will apply high-sensitivity total-body PET/CT imaging using the investigational radiotracer \[¹⁸F\]F-AraG to map immune activation across diverse tissues in PASC and COVID-19-recovered control participants. The tracer, \[¹⁸F\]F-AraG, selectively accumulates in activated T cells and allows kinetic modeling of immune cell activity in vivo. A total of 51 participants will be enrolled, including 34 PASC participants and 17 controls. All participants will undergo baseline imaging, and a subset of 17 PASC participants will complete two additional follow-up scans at 4 and 8 months. Each imaging visit includes a dynamic PET/CT scan, peripheral blood draws for plasma proteomics and immunophenotyping, and symptom questionnaires collected through the UCSF LIINC cohort. Findings will be used to identify tissue-specific immune signatures associated with symptom phenotypes and assess how these evolve over time. The results will help clarify the biological basis of PASC and support the development of future diagnostic or monitoring strategies. No direct health benefit is anticipated for participants.

Conditions

• PASC Post Acute Sequelae of COVID-19

Interventions

Type	Name	Description
DRUG	A.1 - [¹⁸F]F-AraG PET/CT (90-min dynamic + 4-h static)	Participants receive an intravenous injection of 5 mCi (±20%) of \[¹⁸F\]F-AraG followed by a 90-minute total-body PET/CT scan and an additional 30-minute static scan at 4 hours post-injection. Blood samples (up to 42 mL total) are collected during dynamic imaging.
DRUG	A.2 - [¹⁸F]F-AraG PET/CT (60-min dynamic only)	Participants receive an intravenous injection of 5 mCi (±20%) of \[¹⁸F\]F-AraG followed by a 60-minute total-body PET/CT scan. Blood samples (up to 42 mL total) are collected during dynamic imaging.
DRUG	B.1 - [¹⁸F]F-AraG PET/CT (90-min dynamic + 4-h static)	Participants receive an intravenous injection of 5 mCi (±20%) of \[¹⁸F\]F-AraG followed by a 90-minute total-body PET/CT scan and a second 30-minute scan at 4 hours. Blood samples (up to 42 mL total) are collected during dynamic imaging.
DRUG	B.2 - [¹⁸F]F-AraG PET/CT (60-min dynamic only)	Participants receive 5 mCi (±20%) of \[¹⁸F\]F-AraG intravenously followed by a 60-minute total-body PET/CT scan. Blood samples (up to 42 mL total) are collected during dynamic imaging.

Timeline

• Start date: 2025-12-04
• Primary completion: 2028-12-01
• Completion: 2029-12-01
• First posted: 2025-07-22
• Last updated: 2026-02-02

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study