Imaging immune activation in COVID-19 patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: timothy.henrich@ucsf.edu
• Phone: 6282065518

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Investigating olfactory dysfunction after COVID-19 infection

  This study is trying to understand why some people still have trouble smelling after recovering from COVID-19 by looking at samples from their noses.

  Recruiting at 6 sites Universitaire Ziekenhuizen KU Leuven · Brussels, Brussels Capital and 6 other locations · NCT06482138

• Registry to evaluate pregnancy outcomes in women treated for COVID-19

  This study is trying to see how treatments for COVID-19, like certain medications, affect the health of pregnant women and their babies.

  Recruiting Pregistry · Los Angeles, California · NCT05013632

• Collecting COVID-19 virus secretions and serum for developing treatments

  This study is collecting samples from people with COVID-19 to learn more about how the virus behaves and how it affects recovery, with the goal of improving treatments for those at higher risk.

  Recruiting at 2 sites Tulane University · New Orleans, Louisiana and 1 other locations · NCT04956445

• Using donor-derived T cells to treat mild to moderate COVID-19

  This study is testing whether T cells from family members who have recovered from COVID-19 can help treat hospitalized patients with mild to moderate COVID-19.

  Recruiting Phase 1/2 New York Medical College · Valhalla, New York and 3 other locations · NCT04896606

• Observational study on the biology of COVID-19 in Saarland

  This study looks at how COVID-19 affects people in different ways, including those with long-term symptoms, to learn more about the disease and its progression.

  Recruiting Universität des Saarlandes · Homburg, Saarland · NCT04837755

• AGILE: an early-phase platform testing treatments for COVID-19

  This project tests several experimental antiviral and immune therapies to see if they are safe and work for adults with confirmed COVID-19.

  Recruiting at 4 sites Phase 1/2 University of Liverpool · Cape Town and 6 other locations · NCT04746183

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.