Imaging Immune Activation in COVID-19

Part of paid clinical trials in San Francisco, California.

Sponsor
CellSight Technologies, Inc.
Study ID
NCT04815096
Phase
PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Apr 15, 2021
Status verified
May 2026
Primary completion
Oct 1, 2027
Completion
Oct 1, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

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

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

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94110
Timothy J Henrich, MD
415-206-5518
Timothy J Henrich, MD (PRINCIPAL_INVESTIGATOR)
Henry F Vanbrocklin, PhD (SUB_INVESTIGATOR)
Robert Flavel, MD (SUB_INVESTIGATOR)

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