RECRUITING

Imaging Immune Activation in COVID-19

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Imaging Immune Activation in COVID-19

Quick Facts

Study Start:2021-04-15

Study Completion:2025-10-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04815096

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Timothy Henrich, MD

CONTACT

6282065518

timothy.henrich@ucsf.edu

Kofi Asare

CONTACT

Kofi.asare@ucsf.edu

Principal Investigator

Timothy Henrich, MD

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco

San Francisco, California, 94110

United States

Collaborators and Investigators

Sponsor: CellSight Technologies, Inc.

Timothy Henrich, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-15

Study Completion Date2025-10-01

Study Record Updates

Study Start Date2021-04-15

Study Completion Date2025-10-01

Terms related to this study

Keywords Provided by Researchers

PET-CT Imaging
[18F]F-AraG

Additional Relevant MeSH Terms

Covid19
SARS-CoV Infection