NCT04815096 Imaging Immune Activation in COVID-19

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 80 participants in total. It began in 2021-04-15 with a primary completion date of 2027-10-01.

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 participants with convalescent COVID-19. Up to 80 participants will be enrolled over an accrual period of approximately 48 months.

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.

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