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PASC Post Acute Sequelae of COVID-19Early Phase 1NCT07076862

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

A Early Phase 1 study testing A.1 - [¹⁸F]F-AraG PET/CT (90-min dynamic + 4-h static), A.2 - [¹⁸F]F-AraG PET/CT (60-min dynamic only) and B.1 - [¹⁸F]F-AraG PET/CT (90-min dynamic + 4-h static) in people with PASC Post Acute Sequelae of COVID-19, run by University of California, Davis at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
PASC Post Acute Sequelae of COVID-19
What is being tested?
A.1 - [¹⁸F]F-AraG PET/CT (90-min dynamic + 4-h static), A.2 - [¹⁸F]F-AraG PET/CT (60-min dynamic only) and B.1 - [¹⁸F]F-AraG PET/CT (90-min dynamic + 4-h static)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
2 sitesUnited States
Study dates
4 Dec 2025to Dec 2029
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Ability to understand the purposes and risks of the trial and willingness to sign an IRB-approved informed consent form.
  • Willingness and ability to comply with all protocol required procedures.
  • 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.
  • 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.
  • 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.
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  • Ability to travel to our research sites in San Francisco and Sacramento.
  • Laboratory evaluations obtained within 60 days prior to entry:
  • Hemoglobin ≥ 8g/dL
  • Platelet count ≥ 75,000 cells/mm3
  • Absolute neutrophil count (ANC) > 1000 cells/mm3
  • Aspartate aminotransferase (AST) < 3 × ULN units/L
  • Alanine aminotransferase (ALT) < 3 × ULN units/L
  • 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)
  • 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 )
  • 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.

Who cannot join

  • Serious comorbidities (nonmalignant disease or other conditions) that in the opinion of the investigator could compromise protocol objectives.
  • 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).
  • Received vaccination of any type, including a SARS-CoV-2 vaccine, within 30 days of imaging
  • 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).
  • Participants who have had prior allogeneic stem cell or solid organ transplant.
  • Previously diagnosed myelodysplasia syndrome or history of lymphoproliferative disease prior to study entry.
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  • Active systemic autoimmune diseases not related to COVID-19.
  • Self-reported history of dysphoria or anxiety in closed spaces (i.e., uncontrolled claustrophobia).
  • Concurrent or prior enrollment in a separate research study involving a PET scan performed within the last 12 months for research purposes only.
  • Body weight is more than 240 kg (529 pounds)
  • Prisoners
  • Life expectancy < 24 months
  • Recent use of medication including guanosine or cysteine analogs.
  • Any other criteria which would make the participant unsuitable for enrollment to this study, as determined by the Principal Investigator.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Research Team contact

415-502-2449

LIINC@ucsf.edu

Lynn Ngo contact

Lynn.Ngo@ucsf.edu

United States2 sites, 2 recruiting
  • UC Davis EXPLORER Molecular Imaging Center

    Sacramento, California, 95816

    Clinical Research Team, 415-502-2449, LIINC@ucsf.edu

    Negar Omidvari, PhD

    Recruiting
  • University of California San Francisco

    San Francisco, California, 94110

    LIINC Study Team, 415-502-2449, LIINC@ucsf.edu

    Timothy Henrich, MD

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
A.1 - [¹⁸F]F-AraG PET/CT (90-min dynamic + 4-h static), A.2 - [¹⁸F]F-AraG PET/CT (60-min dynamic only), B.1 - [¹⁸F]F-AraG PET/CT (90-min dynamic + 4-h static), B.2 - [¹⁸F]F-AraG PET/CT (60-min dynamic only)
Medical subject headings
Post-Acute COVID-19 Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • A.1 - [¹⁸F]F-AraG PET/CT (90-min dynamic + 4-h static)Drug

    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)Drug

    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)Drug

    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)Drug

    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.

Study groups in NCT07076862
Study groupRoleWhat they receive
A.1 - Control Group (90-min dynamic + 4-h static PET/CT)ExperimentalControl 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.
Receives: Drug: A.1 - [¹⁸F]F-AraG PET/CT (90-min dynamic + 4-h static)
A.2 - Control Group (60-min dynamic PET/CT only)ExperimentalControl 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.
Receives: Drug: A.2 - [¹⁸F]F-AraG PET/CT (60-min dynamic only)
B.1 - PASC Group (90-min dynamic + 4-h static PET/CT)ExperimentalPASC 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.
Receives: Drug: B.1 - [¹⁸F]F-AraG PET/CT (90-min dynamic + 4-h static)
B.2 - PASC Group (60-min dynamic PET/CT only)ExperimentalPASC 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.
Receives: Drug: B.2 - [¹⁸F]F-AraG PET/CT (60-min dynamic only)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quantification of [¹⁸F]F-AraG uptake kinetics in PASC and control participants

    To assess immune activation in convalescent COVID-19, dynamic PET/CT scans will be analyzed to generate time-activity curves (TACs) in multiple tissues. Kinetic modeling will be applied to extract uptake parameters including SUV, SUVR, Vt, Ki, and k3. These values will be reported and statistically compared between PASC and control participants.

    Measured: Baseline Imaging Visit

  2. Correlation between [¹⁸F]F-AraG uptake parameters and blood-based markers of immune dysregulation

    Spearman correlation tests and heat map clustering will be used to assess the association between PET-derived uptake measures and plasma biomarkers of inflammation and immune activation. Correlations will be examined in tissues showing significant uptake differences between study groups.

    Measured: Baseline imaging visit and baseline blood draw

  3. Longitudinal change in [¹⁸F]F-AraG uptake and correlation with PASC symptom scores

    In a subset of participants, follow-up PET/CT imaging at 4 and 8 months will be used to assess within-subject change in kinetic uptake parameters. These changes will be compared to changes in symptom burden as measured by PHQ-15 symptom domain scores.

    Measured: Baseline, 4-month, and 8-month follow-up visits (subset of PASC participants only)

Secondary outcomes (2)
  1. Feasibility of blood flow kinetic modeling using early [¹⁸F]F-AraG dynamic PET data

    Early-phase TACs (< 5 min post-injection) will be fitted using the AATH model to estimate blood flow from the vascular phase of radiotracer distribution. Identifiability of kinetic parameters associated with vascular function will be evaluated. Mean values will be compared between study groups.

    Measured: Baseline imaging visit

  2. Correlation between vascular imaging parameters and blood biomarkers of vascular dysfunction

    Spearman correlations and heatmap analyses will be used to examine associations between PET-derived vascular parameters and plasma markers of vascular dysfunction.

    Measured: Baseline imaging visit and baseline blood draw

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2025
  2. Study start4 Dec 2025
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Participants will be enrolled into one of four parallel imaging subgroups based on disease status and study group assignment. No crossover will occur.
Masking
None (open label)
Enrolment
51 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07076862
Sponsor's protocol ID
2339805
Other IDs
1R01AI185685-01A1
Status last verified
May 2026
First submitted
10 Jul 2025
Last updated
22 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing A.1 - [¹⁸F]F-AraG PET/CT (90-min dynamic + 4-h static), A.2 - [¹⁸F]F-AraG PET/CT (60-min dynamic only) and B.1 - [¹⁸F]F-AraG PET/CT (90-min dynamic + 4-h static) in people with PASC Post Acute Sequelae of COVID-19, run by University of California, Davis at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Research Team (415-502-2449, LIINC@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quantification of [¹⁸F]F-AraG uptake kinetics in PASC and control participants (time frame: Baseline Imaging Visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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