Identification and Characterization of SARS-CoV-2 Specific CD8 T Cells in Humans a Clinical Observation Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Determine CD8 T cells that are responsive to SARS-CoV-2.
研究概览
简要总结
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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详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Ability of subject to understand the study and stated willingness to comply with all study procedures and availability for the duration of the study.
- •Male or female, aged 18 years or older.
- •Able to speak and read English.
- •Willingness and ability to come to the NIA Clinical Research Unit at MedStar Harbor Hospital in Baltimore for study procedures.
- •Proof of positive SARS-CoV-2 testing exhibiting no current clinical symptoms.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Unable to verify identification of volunteer by state issued ID card, driver's license, or military ID. Participants earning greater than $600.00/year are issued a 1099 form, therefore, positive identification is required.
- •Unable to provide informed consent
- •Current use of steroids, immunosuppressive medications, radiation therapy, or chemotherapy medications.
- •Received immunization therapy for COVID-19 or have received a COVID-19 vaccination prior to Visit
- •In addition, eligible participants may not be immediately able to participate in the study but might be eligible at a later date. These include:
- •Symptoms of a viral infection on visit 1 (defer until resolved).
- •Medication: Volunteers taking the following medications would be deferred for 2 weeks after course has been completed and volunteer is feeling well: Antibiotics, antifungals, antimalarials, antvirals.
- •Temporary steroids (tapers): Deferred for 72 hours after symptoms are resolved and prescription is completed if taken orally, intravenously, or intramuscular. No deferral if taken intranasal, inhaled, or for joint injection.
- •Infection or Fever: Deferred until 2 weeks after antibiotics are completed and /or volunteer is feeling well.
- •We wish to only select recovered confirmed COVID-19 patients. Therefore, those who may have a household member (co-habitant) who is newly diagnosed with COVID-19 or who has symptoms will be deferred for 14 days.
- •Treatment with another investigational drug or other intervention within 14 days of visit 1 per the discretion of the Principal Investigator.
研究组 & 干预措施
1
COVID-19 recovered adult patients
结局指标
主要结局
Determine CD8 T cells that are responsive to SARS-CoV-2.
时间窗: 4 month and 1 year data
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.
次要结局
- Determine CD8 T cells that are responsive to SARS-CoV-2.(Ongoing)