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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
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
CellSight Technologies, Inc.

Study Description
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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 20 participants will be enrolled over an accrual period of approximately 24 months. Each participant will undergo one PET-CT scan following 50 +/- 10 minutes uptake following a single bolus injection of [18F]F-AraG in order to determine the tissue distribution of tracer in pariticpants with recent SARS-CoV-2 infection. A second optional [18F]F-AraG dose and PET-CT will be offered approximately 4 months following the initial imaging time point.

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

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 5 months (optional, 4 months following first PET imaging visit) following onset of symptoms (N = 20). Tracer activity will also be compared with sex and age-matched uninfected historical control participants enrolled in prior studies. Up to 20 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 4 months following the initial imaging time point.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: [18F]F-AraG

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


Outcome Measures
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Primary Outcome Measures :
  1. [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.


Secondary Outcome Measures :
  1. [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.

  2. [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

  3. [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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Timothy Henrich, MD 6282065518 timothy.henrich@ucsf.edu
Contact: Leo Torres Leonel.torres@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94110
Contact: Timothy J Henrich, MD    415-206-5518    timothy.henrich@ucsf.edu   
Principal Investigator: Timothy J Henrich, MD         
Sub-Investigator: Henry F Vanbrocklin, PhD         
Sub-Investigator: Robert Flavel, MD         
Sponsors and Collaborators
CellSight Technologies, Inc.
University of California, San Francisco
Investigators
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Principal Investigator: Timothy Henrich, MD University of California, San Francisco
More Information
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Responsible Party: CellSight Technologies, Inc.
ClinicalTrials.gov Identifier: NCT04815096    
Other Study ID Numbers: 20-32477
First Posted: March 24, 2021    Key Record Dates
Last Update Posted: March 29, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CellSight Technologies, Inc.:
PET-CT Imaging
[18F]F-AraG
Additional relevant MeSH terms:
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Severe Acute Respiratory Syndrome
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases