RecruitingPhase 2NCT04815096

Imaging Immune Activation in COVID-19

Sponsor

CellSight Technologies, Inc.

Enrollment

80 participants

Start Date

Apr 15, 2021

Study Type

INTERVENTIONAL

Conditions

COVID19 SARS-CoV Infection

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

Eligibility

Min Age: 18 Years

Inclusion Criteria11

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 Criteria11

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.

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Interventions

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.