Imaging Immune Activation in COVID-19

Launched by CELLSIGHT TECHNOLOGIES, INC. · Mar 23, 2021

Keywords

ClinConnect Summary

This clinical trial, titled "Imaging Immune Activation in COVID-19," aims to better understand how the immune system responds in individuals who have recently recovered from COVID-19. Researchers will use a special imaging technique called PET-CT after giving participants a very small dose of a tracer substance. Up to 80 participants will be enrolled over the next four years, and the study is currently looking for volunteers who are at least 18 years old, have had a confirmed case of COVID-19, and have been symptom-free for at least 14 days.

If you decide to participate, you will undergo some health evaluations and then receive the tracer before having your whole body scanned. It's important to note that certain medical conditions, like pregnancy or recent organ transplants, may prevent someone from being eligible. Additionally, women of childbearing age will need to take a pregnancy test and follow specific guidelines regarding contraception. This study is an opportunity to contribute to important research that could help improve understanding of COVID-19 recovery and immune function.

Gender

ALL

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.