Multiparametric [18F]F-AraG Imaging in Post-Acute Sequelae of COVID-19 (PASC)
NCT ID: NCT07076862
Last Updated: 2026-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
51 participants
INTERVENTIONAL
2025-12-04
2029-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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A.1 - Control Group (90-min dynamic + 4-h static PET/CT)
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.
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.
A.2 - Control Group (60-min dynamic PET/CT only)
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.
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.
B.1 - PASC Group (90-min dynamic + 4-h static PET/CT)
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.
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.
B.2 - PASC Group (60-min dynamic PET/CT only)
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.
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.
Interventions
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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.
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.
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.
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
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Inclusion Criteria
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
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.
18 Years
ALL
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
University of California, San Francisco
OTHER
University of California, Davis
OTHER
Responsible Party
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Principal Investigators
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Negar Omidvari, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis
Locations
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UC Davis EXPLORER Molecular Imaging Center
Sacramento, California, United States
University of California San Francisco
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Clinical Research Team
Role: primary
Other Identifiers
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2339805
Identifier Type: -
Identifier Source: org_study_id
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