Imaging Immune Activation in COVID-19

Recruiting now · Phase 2

Conditions studied: Covid19, SARS-CoV Infection

In brief

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 80 participants will be enrolled over an accrual period of approximately 48 months.

Key facts

Study ID

NCT04815096

Run by

CellSight Technologies, Inc.

People needed

80

Starts

2021-04-15

Expected to finish

2028-10-01

Last updated by the study team

2026-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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.

Where it is running

• University of California, San Francisco — San Francisco, California, United States (enrolling)

Full record on ClinicalTrials.gov

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