Imaging Immune Activation in COVID-19

Description

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.

Conditions

Covid19, SARS-CoV Infection

Study Overview

Study Details

Study overview

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.

Imaging Immune Activation in COVID-19

Imaging Immune Activation in COVID-19

Condition
Covid19
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of California, San Francisco, San Francisco, California, United States, 94110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

CellSight Technologies, Inc.,

Timothy Henrich, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

2025-10-01