NCT07076862 Multiparametric [18F]F-AraG Imaging in Post-Acute Sequelae of COVID-19 (PASC)
| NCT ID | NCT07076862 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of California, Davis |
| Condition | PASC Post Acute Sequelae of COVID-19 |
| Study Type | INTERVENTIONAL |
| Enrollment | 51 participants |
| Start Date | 2025-12-04 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 51 participants in total. It began in 2025-12-04 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Negar Omidvari, PhD
PRINCIPAL INVESTIGATOR
University of California, Davis
Frequently Asked Questions
Who can join the NCT07076862 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying PASC Post Acute Sequelae of COVID-19. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07076862 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07076862 currently recruiting?
Yes, NCT07076862 is actively recruiting participants. Contact the research team at LIINC@ucsf.edu for enrollment information.
Where is the NCT07076862 trial being conducted?
This trial is being conducted at Sacramento, United States, San Francisco, United States.
Who is sponsoring the NCT07076862 clinical trial?
NCT07076862 is sponsored by University of California, Davis. The principal investigator is Negar Omidvari, PhD at University of California, Davis. The trial plans to enroll 51 participants.
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