Imaging Immune Activation in COVID-19

NCT04815096 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 20-32477
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

PET-CT Imaging; [18F]F-AraG

Outcome Measures

Primary Outcomes (1)

• Determine the 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 Outcomes (3)

• [18F]F-AraG uptake in participants with convalescent COVID-19 over time

  5 months

• Determine if [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.

  1 year

• Determine if [18F]F-AraG uptake correlates with direct blood measures of immune activation and SARS-CoV-2 specific T cell responses.

  1 year

Study Arms (1)

[18F]F-AraG

EXPERIMENTAL

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)

Interventions

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

\[18F\]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.

Also known as: VisAcT

[18F]F-AraG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CellSight Technologies, Inc.: lead
• University of California, San Francisco: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94110, United States

RECRUITING

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Timothy Henrich, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy Henrich, MD

CONTACT

6282065518; timothy.henrich@ucsf.edu

Kofi Asare

CONTACT

Kofi.asare@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 24, 2021
• Study Start: April 15, 2021
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)