This is a single center, single arm exploratory imaging study involving up to twointravenous microdoses of [18F]F-AraG (the second tracer dose is optional) followed bywhole-body PET-CT imaging in participants with convalescent COVID-19. Up to 80participants will be enrolled over an accrual period of approximately 48 months.
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 1 month to 1 year (optional, 1 month to one year
following first PET imaging visit) following onset of symptoms (N = 80). Tracer activity
will also be compared with uninfected historical control participants enrolled in prior
studies. Up to 80 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
1 month to one year following the initial imaging time point.
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
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).
- 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.
University of California, San Francisco
San Francisco, California, United States
Investigator: Timothy J Henrich, MD
Contact: 415-206-5518
timothy.henrich@ucsf.edu
Timothy Henrich, MD
6282065518
timothy.henrich@ucsf.edu
Kofi Asare
Kofi.asare@ucsf.edu
Timothy Henrich, MD, Principal Investigator
University of California, San Francisco