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Imaging Immune Activation in COVID-19

C

CellSight Technologies

Status and phase

Enrolling
Early Phase 1

Conditions

SARS-CoV Infection
Covid19

Treatments

Drug: [18F]F-AraG (2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine)

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04815096
20-32477

Details and patient eligibility

About

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.

Full description

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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

[18F]F-AraG
Experimental group
Description:
Radiofluorinated imaging agent, [18F]F-AraG (2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine) Trade name: VisAcT
Treatment:
Drug: [18F]F-AraG (2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine)

Trial contacts and locations

1

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Central trial contact

Timothy Henrich, MD; Leo Torres

Data sourced from clinicaltrials.gov

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