Recruiting
Phase 2

Immune Activation

Sponsor:

CellSight Technologies, Inc.

Code:

NCT04815096

Conditions

Covid19

SARS-CoV Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief 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.

Conditions

Covid19

SARS-CoV Infection

Study ID

NCT04815096

Start date

Apr 15, 2021

Status verified date

May, 2026

Completion date

Oct 1, 2028

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: [18F]F-AraG

Radiofluorinated imaging agent, \[18F\]F-AraG (2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine)

Trade name: VisAcT

Interventions

[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.

Primary outcome measure

  • Anatomical distribution of [18F]F-AraG in participant with convalescent COVID-19 greater than 4 weeks (N = 80). Tracer activity will be compared with sex and age-matched uninfected historical control participants enrolled in prior studies. [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Timothy Henrich, MD

6282065518timothy.henrich@ucsf.edu

Kofi Asare

Kofi.asare@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94110

Contacts

Timothy J Henrich, MD

415-206-5518timothy.henrich@ucsf.edu

Principal Investigator:

Timothy J Henrich, MD

More Information

Sponsor

CellSight Technologies, Inc.

Last update posted

May 8, 2026

Last verified

May, 2026

Keywords

  • PET-CT Imaging
  • [18F]F-AraG

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CellSight Technologies, Inc. on 2026-05-08.