Imaging immune activation in COVID-19 patients

Imaging Immune Activation in COVID-19

This study is testing a special imaging technique to see how the immune system is working in people who have recently recovered from COVID-19.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: CellSight Technologies, Inc. (industry)
• Drugs / interventions: radiation
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT04815096 on ClinicalTrials.gov

What this trial studies

This exploratory imaging study involves administering up to two microdoses of the tracer [18F]F-AraG to participants who have recently recovered from COVID-19, followed by whole-body PET-CT imaging. The study aims to assess the anatomical distribution of the tracer in these individuals approximately 4 weeks and optionally 1 month to 1 year after the onset of symptoms. A total of 80 participants will be enrolled, and their tracer activity will be compared to historical controls who were not infected. The study will take place at a single center, the University of California, San Francisco.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old who have had a recent diagnosis of SARS-CoV-2 infection and are at least 14 days post-symptom onset.

Not a fit: Patients with medical conditions that could compromise imaging acquisition or those who are pregnant may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of immune activation in COVID-19, potentially leading to improved diagnostic and therapeutic strategies.

How similar studies have performed: While this approach is exploratory, similar imaging studies have shown promise in understanding immune responses in other conditions, suggesting potential for success.

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.

Where this trial is running

San Francisco, California

• University of California, San Francisco — San Francisco, California, United States (RECRUITING)

Study contacts

• Principal investigator: Timothy Henrich, MD — University of California, San Francisco
• Study coordinator: Timothy Henrich, MD

Conditions: Covid19, SARS-CoV Infection, PET-CT Imaging, [18F]F-AraG