NCT04815096

Imaging Immune Activation in COVID-19

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: CellSight Technologies, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Covid19
• SARS-CoV Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-04-15
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2021-03-24
• Last updated: 2024-10-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study