Imaging Immune Activation in COVID-19
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|ClinicalTrials.gov Identifier: NCT04815096|
Recruitment Status : Recruiting
First Posted : March 24, 2021
Last Update Posted : March 29, 2021
|Condition or disease||Intervention/treatment||Phase|
|Covid19 SARS-CoV Infection||Drug: [18F]F-AraG (2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine)||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model 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.|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Imaging Immune Activation in COVID-19|
|Estimated Study Start Date :||April 15, 2021|
|Estimated Primary Completion Date :||March 1, 2023|
|Estimated Study Completion Date :||March 1, 2023|
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 Name: VisAcT
- [18F]F-AraG uptake in participants with convalescent COVID-19 [ Time Frame: 4 weeks ]To determine regional uptake of [18F]F-AraG in participants with convalescent COVID-19.
- [18F]F-AraG uptake in participants with convalescent COVID-19 over time [ Time Frame: 5 months ]To determine the anatomical distribution of [18F]F-AraG in participant with convalescent COVID-19 approximately 4 weeks and 5 months (optional) over time.
- [18F]F-AraG uptake in participants with mild to severe COVID-19 symptoms [ Time Frame: 1 year ]To compare maximum SUV (SUVmax) and the mean SUV (SUVmean) from regions of interest (ROI; e.g. lungs, lymph node chains,) between convalescent COVID-19 individuals with mild (N=10) to those with moderate to severe initial disease (N=10) at each imaging timepoint
- [18F]F-AraG uptake in female versus male participants [ Time Frame: 1 year ]To compare maximum SUV (SUVmax) and the mean SUV (SUVmean) from regions of interest (ROI; e.g. lungs, lymph node chains,) between male and female participants with convalescent COVID-19 at each imaging time point.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04815096
|Contact: Timothy Henrich, MDemail@example.com|
|Contact: Leo Torres||Leonel.firstname.lastname@example.org|
|United States, California|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94110|
|Contact: Timothy J Henrich, MD 415-206-5518 email@example.com|
|Principal Investigator: Timothy J Henrich, MD|
|Sub-Investigator: Henry F Vanbrocklin, PhD|
|Sub-Investigator: Robert Flavel, MD|
|Principal Investigator:||Timothy Henrich, MD||University of California, San Francisco|