Clinical trial NCT04815096: Imaging Immune Activation in COVID-19
Official title: Imaging Immune Activation in COVID-19
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Covid19
SARS-CoV Infection
Keywords: PET-CT Imaging
[18F]F-AraG
Lead sponsor: CellSight Technologies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Francisco
First posted: 2021-03-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: BASIC_SCIENCE

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 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.

Eligibility 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.

Primary outcomes:
measure: Determine the 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.
timeFrame: 4 weeks
Secondary outcomes:
measure: [18F]F-AraG uptake in participants with convalescent COVID-19 over time
timeFrame: 5 months
measure: Determine if [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.
timeFrame: 1 year
measure: Determine if [18F]F-AraG uptake correlates with direct blood measures of immune activation and SARS-CoV-2 specific T cell responses.
timeFrame: 1 year
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Timothy Henrich, MD
role: PRINCIPAL_INVESTIGATOR
References: