Imaging Immune Activation in COVID-19
a study on COVID-19
This is a single center, single arm 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 with convalescent COVID-19. Up to 20 participants will be enrolled over an accrual period of approximately 24 months. Each participant will undergo one PET-CT scan following 50 +/- 10 minutes uptake following a single bolus injection of [18F]F-AraG in order to determine the tissue distribution of tracer in pariticpants with recent SARS-CoV-2 infection. A second optional [18F]F-AraG dose and PET-CT will be offered approximately 4 months following the initial imaging time point.
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. The primary objective is to determine the anatomical distribution of [18F]F-AraG in participant with convalescent COVID-19 approximately 4 weeks and 5 months (optional, 4 months following first PET imaging visit) following onset of symptoms (N = 20). Tracer activity will also be compared with sex and age-matched uninfected historical control participants enrolled in prior studies. Up to 20 participants will be enrolled in this study who will be identified in the UCSF LIINC longitudinal COVID-19 cohort study. Each participant will undergo one PET-CT scan following 50 +/- 10 minutes uptake following a single bolus injection of [18F]F-AraG. A second optional [18F]F-AraG dose and PET-CT will be offered approximately 4 months following the initial imaging time point.
Covid19 SARS-CoV Infection PET-CT Imaging [18F]F-AraG Severe Acute Respiratory Syndrome [18F]F-AraG (2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine)
You can join if…
Open to people ages 18 years and up
- 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).
- 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
You CAN'T join if...
- 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.
- University of California, San Francisco
accepting new patients
San Francisco California 94110 United States
Lead Scientist at UCSF
- accepting new patients
- Start Date
- Completion Date
- CellSight Technologies, Inc.
- Phase 1
- Study Type
- Last Updated
Please contact me about this study
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If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT04815096.