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Dynamic assessment of immune system in COVID-19 patients Pilot Study 2: Aging and the Cutaneous Immune System in Young and Older Adults
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21-095J-2
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Dynamic assessment of immune system in COVID-19 patients Pilot Study 2: Aging and the Cutaneous Immune System in Young and Older Adults
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Dr. George Kuchel
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This prospective, single-site pilot study is designed to determine the feasibility to recruit and enroll COVID-19 convalescent adults into a study that will assess immunity changes associated with aging. To complete a 8-subject pilot study with the following aims: To establish feasibility of conducting a larger trial with the enrollment of adults that have recovered from COVID-19 and healthy adults, we will enroll 4 younger adults (25-50 years) and 4 older adults (>65 years) and collect skin samples using punch biopsy and blood samples. To enumerate and assess functional status of dendritic cells, monocytes, macrophages, T cells and B cells in skin biopsies using multi-marker immunofluorescence and histo-cytometry (10+ markers) as well as image mass spectrometry (IMC) (30+ marker analysis in intact tissues). This is a prospective, single-site pilot study that will use an established and comprehensive approach to cellular and molecular analysis of non-dissociated tissues that will be applied herein to assess tissue immunity and changes associated with COVID-19 and aging. In this study, a total of 8 healthy adult participants who have either recovered from COVID-19 or have had no history of confirmed COVID-19 will be enrolled: four (4) older adults aged 65 years and older and four (4) younger adults aged 25-50 years. Participation in the study will involve two study visits scheduled on two consecutive days and up to three follow-ups via phone or email over three weeks after the biopsies. Subjects will be administered an intradermal injection of saline on one arm and two punch skin biopsies will be performed at the site of injection and adjacent the next day under local anesthesia. The biopsy sites will be closed with an absorbable suture. Peripheral blood specimens (50 mL each) will be collected at both study visits. Self-reported medical history, medication history and demographics information will be collected at Visit 1.
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Infectious Disease/Immune System
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Skin
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Check with study contact
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Natalie Cantalicio. Telephone: 860-679-8573. Email: cantalicio@uchc.edu or Lisa Pesce. Telephone: 860-679-2305. Email:kenyon-pesce@uchc.edu
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Enrolling/recruiting. For current recruitment status, please check with study contact.
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