Status:
RECRUITING
Imaging Immune Activation in COVID-19
Lead Sponsor:
CellSight Technologies, Inc.
Collaborating Sponsors:
University of California, San Francisco
Conditions:
Covid19
SARS-CoV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04815096
Start Date
April 15 2021
End Date
October 1 2025
Last Update
October 24 2024
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94110