Imaging Immune Activation in COVID-19
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCellSight Technologies, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
[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.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: [18F]F-AraGExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
4 weeksSecondary outcomes
1
[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.
Time frame
5 months2
[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).
Time frame
1 year3
[18F]F-AraG uptake correlates with direct blood measures of immune activation and SARS-CoV-2 specific T cell responses.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
CellSight Technologies, Inc.
Lead sponsor
University of California, San Francisco
Collaborator
Source ClinicalTrials.gov