Imaging Immune Activation in COVID-19

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CellSight Technologies, Inc.
• Collaborator: University of California, San Francisco

Criteria

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.