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

This study uses total-body [¹⁸F]F-AraG PET/CT imaging to investigate immune activationand 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 alongwith blood biomarker assessments and symptom evaluations. The study aims to characterizesites of immunological perturbation, correlate PET imaging findings with peripheral bloodmarkers, and evaluate longitudinal changes in tissue-based immune activity in relation tosymptom patterns over time. Data from this study will improve understanding oftissue-level immune dysregulation in PASC and support future clinical tools for assessingand 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.

Not yet recruiting
PASC Post Acute Sequelae of COVID-19

Diagnostic Test: 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.

Diagnostic Test: 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.

Diagnostic Test: 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.

Diagnostic Test: 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.

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 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.

6. 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.

7. Ability to travel to our research sites in San Francisco and Sacramento.

8. Laboratory evaluations obtained within 60 days prior to entry:

1. Hemoglobin ≥ 8g/dL

2. Platelet count ≥ 75,000 cells/mm3

3. Absolute neutrophil count (ANC) > 1000 cells/mm3

4. Aspartate aminotransferase (AST) < 3 × ULN units/L

5. Alanine aminotransferase (ALT) < 3 × ULN units/L

6. Calculated creatinine clearance (CrCl) ≥ 60mL/min as estimated by the
Cockcroft-Gault equation:

For men, (140 - age in years) × (body weight in kg) ÷ (serum creatinine in mg/dL ×
72) = CrCl (mL/min)*

*For women, multiply the result by 0.85 = CrCl (mL/min)

9. For PASC participants only: Reporting at least 2 unexplained symptoms, with at least
1 symptom in the fatigue domain and at least 1 symptom in either cardiopulmonary or
neurocognitive domains, that last for at least 2 months and cannot be explained by
an alternative diagnosis. Symptoms may be new onset after initial COVID-19 recovery
or persist from the initial acute phase and may fluctuate or relapse over time.
(According to World Health Organization definition of PASC http://www.WHO.int )

10. For control participants only: Individuals who have made full clinical recovery
within 4-12 weeks of acute COVID-19 infection with no newly developed symptoms or
changes in health after recovery.

Exclusion Criteria:

1. Serious comorbidities (nonmalignant disease or other conditions) that in the opinion
of the investigator could compromise protocol objectives.

2. 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).

3. Received vaccination of any type, including a SARS-CoV-2 vaccine, within 30 days of
imaging

4. 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).

5. Participants who have had prior allogeneic stem cell or solid organ transplant.

6. Previously diagnosed myelodysplasia syndrome or history of lymphoproliferative
disease prior to study entry.

7. Active systemic autoimmune diseases not related to COVID-19.

8. Self-reported history of dysphoria or anxiety in closed spaces (i.e., uncontrolled
claustrophobia).

9. Concurrent or prior enrollment in a separate research study involving a PET scan
performed within the last 12 months for research purposes only.

10. Body weight is more than 240 kg (529 pounds)

11. Prisoners

12. Life expectancy < 24 months

13. Recent use of medication including guanosine or cysteine analogs.

14. Any other criteria which would make the participant unsuitable for enrollment to
this study, as determined by the Principal Investigator.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

UC Davis EXPLORER Molecular Imaging Center
Sacramento, California, United States

Investigator: Clinical Research Team
Contact: 916-731-9004

Investigator: Negar Omidvari, PhD

Contacts

Clinical Research Team
916-731-9004
nomidvari@ucdavis.edu

Negar Omidvari, PhD, Principal Investigator
University of California, Davis

University of California, Davis
NCT Number
MeSH Terms
COVID-19
Post-Acute COVID-19 Syndrome