Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT04565067
Brief Summary:
Background:
The higher death rate from COVID-19 in the older population is associated with low CD8 T cell counts in the blood. Researchers want to learn the status of CD8 T cells specific to SARS-CoV-2 and their changes with aging and in COVID-19. This may help to identify why COVID-19 is particularly lethal in the elderly and help to create an effective vaccine against SARS-CoV-2 in the elderly.
Objective:
To identify SARS-CoV-2 specific CD8 T cells in humans, and to determine their quantity and quality in people who have recovered from COVID-19.
Eligibility:
Maryland residents age 18 and older who have tested positive for and recovered from COVID-19.
Design:
Participants will be screened by phone. They must be able to provide a copy of their positive COVID-19 test result.
Participants will visit the NIA/Clinical Research Unit. The visit will take about 1 hour.
Laboratory tests showing a positive COVID-19 result will be verified.
Participants vital signs will be checked. This will include blood pressure, temperature, pulse, and respiration. Height and weight will be measured.
Participants will have a medical history and medicine review. They will complete a COVID-19 questionnaire.
Participants will have blood drawn. They will give a urine sample.
Participants will give a saliva sample. They will rinse their mouth with water. After about 3 minutes, they will let saliva pool in the base of their mouth and then spit into a sterile container.
Participants may be asked if they would be willing to return for optional visits at about 4 months and 1 year later. They will repeat the same laboratory sampling performed at the first visit.
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Detailed Description:
Study Description:
This study is to identify epitopes of SARS-CoV-2 that are recognized by CD8 T cells in the blood of healthy young and old participants as well as COVID-19 recovered. We will also measure general health factors using blood, saliva and urine samples. By analyzing the frequency, differentiation, and expansion of these SARS-CoV-2 recognizing CD8 T cells, we hope to shed light into the T cell immunity against SARS-CoV-2 and its change with age and post-infection.
Objective:
To identify SARS-CoV-2 specific CD8 T cells in humans, and to determine their quantity and quality in recovered COVID-19 patients.
Endpoints:
Primary Endpoint: We are investigating the presence or absence of various SARS-CoV-2 specific CD8 T cells in healthy adults and in COVID-19 recovered patients to understand the composition of CD8 T cell immunity in COVID-19 pathogenesis. We plan to determine CD8 T cells that are responsive to SARS-CoV-2.
Secondary Endpoint: To determine the number and quality of SARSCoV-2 specific CD8
Study:
NCT04565067
Study Brief:
Protocol Section:
NCT04565067