[¹⁸F]F-AraG Imaging for Long COVID

Not yet recruiting at 1 trial location

Overseen By Simon Cherry

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of California, Davis

Must not be taking: Guanosine, Cysteine analogs

Disqualifiers: Serious comorbidities, Immune disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the immune system and blood vessels respond in people with Long COVID using a special imaging method called PET/CT. Participants will undergo scans with [18F]F-AraG, a radiotracer used in PET/CT imaging, and provide blood samples to help researchers understand the immune system's activity and its relation to ongoing symptoms. The study aims to uncover more about the body's response to Long COVID, potentially improving future treatments and management. It suits those who have had COVID-19 and continue to experience symptoms like fatigue and brain fog without any other explanation. Participants must travel to San Francisco or Sacramento for study visits. As an Early Phase 1 trial, this study focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who have recently used medications like guanosine or cysteine analogs. It's best to discuss your specific medications with the trial team.

What prior data suggests that [¹⁸F]F-AraG PET/CT imaging is safe for humans?

Research has shown that [¹⁸F]F-AraG is a substance used in PET/CT scans to study immune system activity. Limited information exists on its safety because it remains in the early stages of human testing. However, [¹⁸F]F-AraG is administered in very small amounts, known as microdoses, which help reduce potential risks. So far, participants have not reported any major side effects from these small doses.

As this is an early phase study, the main goal is to learn about the tracer's safety and the body's response to it. At this stage, the full safety profile of a new treatment is not yet known, but early tests aim to identify any issues. Researchers closely monitor participants for any side effects, ensuring safety as more information is gathered. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to understand Long COVID, using a special imaging agent called [¹⁸F]F-AraG. Unlike typical treatments that try to manage symptoms, this trial focuses on using PET/CT scans to see how Long COVID affects the body at a cellular level. The innovative approach allows researchers to visualize immune activity in real-time, which could lead to better diagnosis and understanding of the condition. By capturing detailed images of the body's response, this method could eventually guide the development of more targeted therapies.

What evidence suggests that [¹⁸F]F-AraG imaging is effective for Long COVID?

Research has shown that a special type of scan, called [¹⁸F]F-AraG PET/CT imaging, effectively highlights changes in the immune system of people with Long COVID. In this trial, participants will undergo different scanning protocols to assess immune activity. Studies have found that this scan detects higher activity in certain body areas of those who have had COVID-19 compared to those who haven't. This indicates that the scan can reveal where the immune system is more active. The increased concentration of the imaging agent in these studies supports the idea that this technique can help identify immune system issues related to Long COVID. While it doesn't directly treat the condition, it aids in understanding and potentially managing it better. ^{1 2 6 7 8}

Who Is on the Research Team?

Negar Omidvari, PhD

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

This trial is for individuals experiencing long-term effects after COVID-19, known as Long COVID or PASC. Participants will undergo PET/CT imaging and blood tests to study immune system changes and vascular issues related to their condition.

Inclusion Criteria

For participants of reproductive potential, willingness to use effective double barrier contraceptive methods during the study and up to 1 day after the last administration of the radiotracer

I am 18 years old or older.

Laboratory evaluations within specified ranges

Exclusion Criteria

Serious comorbidities that could compromise protocol objectives

Pregnant or nursing individuals

Active systemic autoimmune diseases not related to COVID-19

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Participants undergo baseline dynamic PET/CT imaging and blood biomarker assessments

1 day

1 visit (in-person)

Follow-up Imaging

A subset of PASC participants undergo follow-up PET/CT imaging at 4 and 8 months to assess changes in immune activity

8 months

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• [18F]F-AraG

Trial Overview [18F]F-AraG PET/CT scans are being tested in two formats: a shorter 60-minute dynamic scan and a longer session including a 90-minute dynamic scan followed by a static scan at 4 hours. The goal is to map immune activity and its correlation with symptoms over time.

How Is the Trial Designed?

Group I: B.2 - PASC Group (60-min dynamic PET/CT only) Experimental Treatment 1 Intervention

PASC participants in this arm will undergo a 60-minute dynamic \[¹⁸F\]F-AraG PET/CT scan. No delayed imaging is performed. Blood samples are collected during imaging.

Group II: B.1 - PASC Group (90-min dynamic + 4-h static PET/CT) Experimental Treatment 1 Intervention

PASC participants in this arm will undergo a 90-minute dynamic \[¹⁸F\]F-AraG total-body PET/CT scan, followed by a second 30-minute static scan approximately 4 hours post-injection. Blood samples are collected during the scan.

Group III: A.2 - Control Group (60-min dynamic PET/CT only) Experimental Treatment 1 Intervention

Control participants in this arm will undergo a 60-minute dynamic \[¹⁸F\]F-AraG total-body PET/CT scan. No delayed imaging will be performed. Blood samples will be collected during the dynamic scan.

Group IV: A.1 - Control Group (90-min dynamic + 4-h static PET/CT) Experimental Treatment 1 Intervention

Control participants in this arm will undergo a 90-minute dynamic \[¹⁸F\]F-AraG total-body PET/CT scan, followed by a second 30-minute static PET/CT scan approximately 4 hours after tracer injection. Blood samples will be collected during the dynamic scan to support kinetic modeling.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07076862?cond=Long+COVID

Multiparametric [18F]F-AraG Imaging in Post-Acute ... 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 ...

2. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT07076862

Multiparametric [18F]F-AraG Imaging in Post-Acute Sequelae ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10418298/

Multimodal Molecular Imaging Reveals Tissue-Based T Cell ... We found that [18F]F-AraG uptake was significantly higher in post-acute COVID participants compared to pre-pandemic controls in many anatomical regions, ...

4. smartpatients.com smartpatients.com/trials/NCT07076862

Multiparametric [18F]F-AraG Imaging in Post-Acute ... 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- ...

5. researchgate.net researchgate.net/publication/372856016_Multimodal_Molecular_Imaging_Reveals_Tissue-Based_T_Cell_Activation_and_Viral_RNA_Persistence_for_Up_to_2_Years_Following_COVID-19

Multimodal Molecular Imaging Reveals Tissue-Based T ... By using [ 18 F]F-AraG, the authors observed that there were increases in the concentration of the probe present throughout the body in those ...

6. withpower.com withpower.com/trial/early-phase-1-post-acute-covid-19-syndrome-9-2025-74aaf

[¹⁸F]F-AraG Imaging for Long COVID · Info for Participants 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 ...

7. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT04815096

Imaging Immune Activation in COVID-19 This is a single center exploratory imaging study involving up to two intravenous microdoses of [18F]F-AraG (the second tracer dose is optional) followed by ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8316133/

18F-FDG-PET/CT in SARS-CoV-2 infection and its sequelae To date, knowledge about the usefulness of 18F-FDG-PET/CT in the acute phase has been limited to the incidental detection of SARS-CoV-2 unsuspected pneumonia.