Imaging Immune Activation in COVID-19

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.

Study Overview

• Status: Recruiting
• Conditions: Covid19; SARS-CoV Infection
• Intervention / Treatment: Drug: [18F]F-AraG (2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine)

Detailed 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 1 month to 1 year (optional, 1 month to one year following first PET imaging visit) following onset of symptoms (N = 80). Tracer activity will also be compared with uninfected historical control participants enrolled in prior studies. Up to 80 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 1 month to one year following the initial imaging time point.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Timothy Henrich, MD; Phone Number: 6282065518; Email: timothy.henrich@ucsf.edu
• Study Contact Backup: Name: Kofi Asare; Email: Kofi.asare@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • Recruiting
      • University of California, San Francisco
      • Sub-Investigator: Robert Flavel, MD
      • Contact: Timothy J Henrich, MD; Phone Number: 415-206-5518; Email: timothy.henrich@ucsf.edu
      • Principal Investigator: Timothy J Henrich, MD
      • Sub-Investigator: Henry F Vanbrocklin, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [18F]F-AraG; Radiofluorinated imaging agent, [18F]F-AraG (2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine) Trade name: VisAcT	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.; Other Names: VisAcT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	To determine regional uptake of [18F]F-AraG in participants with convalescent COVID-19.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
[18F]F-AraG uptake in participants with convalescent COVID-19 over time	To determine the anatomical distribution of [18F]F-AraG in participant with convalescent COVID-19 approximately 4 weeks and 5 months (optional) over time.	5 months
[18F]F-AraG PET-CT is able to detect differences in T cell activation between convalescent COVID-19 participants and age-matched uninfected historical control participants.	Determine if [18F]F-AraG PET-CT is able to detect differences in T cell activation between convalescent COVID-19 participants with and without persistent symptoms (PASC).	1 year
[18F]F-AraG uptake correlates with direct blood measures of immune activation and SARS-CoV-2 specific T cell responses.		1 year

Collaborators and Investigators

• Sponsor: CellSight Technologies, Inc.
• Collaborators: University of California, San Francisco
• Investigators: Principal Investigator: Timothy Henrich, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2021
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: [18F]F-AraG; PET-CT Imaging
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Severe Acute Respiratory Syndrome
• Other Study ID Numbers: 20-32477

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No