Imaging Immune Activation in COVID-19
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ClinicalTrials.gov Identifier: NCT04815096 |
Recruitment Status :
Recruiting
First Posted : March 24, 2021
Last Update Posted : June 30, 2022
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Condition or disease | Intervention/treatment | Phase |
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Covid19 SARS-CoV Infection | Drug: [18F]F-AraG (2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine) | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | 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 whole-body PET-CT imaging in participants 18 years of age and older with recent SARS-CoV-2 diagnosis and COVID-19 at least 14 days following onset of symptoms. |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Imaging Immune Activation in COVID-19 |
Actual Study Start Date : | April 15, 2021 |
Estimated Primary Completion Date : | March 1, 2023 |
Estimated Study Completion Date : | March 1, 2023 |

Arm | Intervention/treatment |
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Experimental: [18F]F-AraG
Radiofluorinated imaging agent, [18F]F-AraG (2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine) Trade name: VisAcT |
Drug: [18F]F-AraG (2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine)
[18F]F-AraG is a radiolabeled high affinity substrate for deoxyguanosine kinase (dGK) and a low affinity substrate for deoxycytidine kinase (dCK), which are over-expressed in activated T cells.
Other Name: VisAcT |
- [18F]F-AraG uptake in participants with convalescent COVID-19 [ Time Frame: 4 weeks ]To determine regional uptake of [18F]F-AraG in participants with convalescent COVID-19.
- [18F]F-AraG uptake in participants with convalescent COVID-19 over time [ Time Frame: 5 months ]To determine the anatomical distribution of [18F]F-AraG in participant with convalescent COVID-19 approximately 4 weeks and 5 months (optional) over time.
- [18F]F-AraG uptake in participants with mild to severe COVID-19 symptoms [ Time Frame: 1 year ]To compare maximum SUV (SUVmax) and the mean SUV (SUVmean) from regions of interest (ROI; e.g. lungs, lymph node chains,) between convalescent COVID-19 individuals with mild (N=10) to those with moderate to severe initial disease (N=10) at each imaging timepoint
- [18F]F-AraG uptake in female versus male participants [ Time Frame: 1 year ]To compare maximum SUV (SUVmax) and the mean SUV (SUVmean) from regions of interest (ROI; e.g. lungs, lymph node chains,) between male and female participants with convalescent COVID-19 at each imaging time point.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age >18 years
- Ability to read and understand written informed consent document
- Have a recent 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.
- > 14 days since onset of COVID-19 symptoms (or if no symptoms, from time of initial nucleic acid based diagnostic test).
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Laboratory evaluations obtained within 60 days prior to entry.
- Platelet count ≥75,000/mm3
- ANC >1000/mm3
- Aspartate aminotransferase (AST) <3 x ULN
- Alanine aminotransferase (ALT) <3 x ULN
- Calculated creatinine clearance (CrCl) ≥60 mL/min as estimated by the Cockcroft-
- Gault equation
Exclusion Criteria:
- Any medical condition that would compromise the imaging acquisition, in the opinion of the investigator
- Participants who are pregnant (female participants of childbearing age will be tested prior to injection of imaging agent at entry visit/initial visit - positive test will exclude from further participation in the study)
- Participants who are breastfeeding
- Female participants of reproductive potential (defined as women 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) must have a negative urine or serum pregnancy test with a sensitivity of at least 25 mIU/mL performed within 24 hours prior to PET imaging. Females of reproductive potential will need to be on 2 forms of birth control (excluding withdrawal or timing methods).
- Participants who have had prior allogeneic stem cell or solid organ transplant.
- Screening absolute neutrophil count <1,000 cells/mm3, platelet count <75,000 cells/mm3, hemoglobin < 8 mg/dL, estimated creatinine clearance <60 mL/minute, aspartate aminotransferase >3 x ULN, alanine aminotransferase >3 x ULN.
- Known SARS-CoV-2 shedding within 5 days of PET imaging.
- Previously diagnosed myelodysplasia syndrome or history of lymphoproliferative disease prior to study entry
- Active systemic autoimmune diseases not related to COVID-19.
- COVID-19 vaccine prior to the first PET imaging session. Participants may receive COVID-19 vaccination after the first PET imaging session and the optional second PET scan, with the scan being performed at least 2 weeks following the most recent vaccine dose.
- Prior PET scan or therapeutic radiation within 1 year of study enrollment.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04815096
Contact: Timothy Henrich, MD | 6282065518 | timothy.henrich@ucsf.edu | |
Contact: Leo Torres | Leonel.torres@ucsf.edu |
United States, California | |
University of California, San Francisco | Recruiting |
San Francisco, California, United States, 94110 | |
Contact: Timothy J Henrich, MD 415-206-5518 timothy.henrich@ucsf.edu | |
Principal Investigator: Timothy J Henrich, MD | |
Sub-Investigator: Henry F Vanbrocklin, PhD | |
Sub-Investigator: Robert Flavel, MD |
Principal Investigator: | Timothy Henrich, MD | University of California, San Francisco |
Responsible Party: | CellSight Technologies, Inc. |
ClinicalTrials.gov Identifier: | NCT04815096 |
Other Study ID Numbers: |
20-32477 |
First Posted: | March 24, 2021 Key Record Dates |
Last Update Posted: | June 30, 2022 |
Last Verified: | June 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
PET-CT Imaging [18F]F-AraG |
COVID-19 Severe Acute Respiratory Syndrome Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |