No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Basic Science
Participants needed
80 (estimated)
Sponsor
CellSight Technologies, Inc. · Industry
Who this trial is looking for
This trial is looking for people who have recently recovered from COVID-19 to participate in an imaging study. Participants will receive a small dose of a tracer followed by a full-body scan to study immune activity.
Are You a Good Fit for This Trial?
Rules you outMyelodysplasia syndromeLymphoproliferative disease
You may be able to join if
I am over 18 years old
I have recently been diagnosed with COVID-19
It has been more than 14 days since I had COVID-19 symptoms
I have laboratory tests showing my platelet count is at least 75,000/mm3
I have laboratory tests showing my ANC is over 1000/mm3
I have laboratory tests showing my creatinine clearance is at least 60 mL/min
You may not be able to join if
I am pregnant or breastfeeding
I have had a stem cell or solid organ transplant
I have active autoimmune diseases not related to COVID-19
I have known SARS-CoV-2 shedding within 5 days of the scan
I have had a prior PET scan or therapeutic radiation in the past year
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
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 …
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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