Investigation of the B- and T-cell Repertoire and Immune Response in Patients With Acute and Resolved COVID-19 Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 679
- 试验地点
- 4
- 主要终点
- Characterize immune response
研究概览
简要总结
Background:
People who get infected with COVID-19 have an unpredictable risk to worsen and die. This makes it hard to decide who can quarantine at home and who should be treated at a hospital. Researchers think the risk may be related to how a person s B and T cells respond to the virus. B and T cells are the major components of a person s immune response. B and T cells responding to the virus with a favorable pattern may lead to recovery, and this favorable pattern may be helpful to establish. If people in a vaccine trial get this same favorable pattern when responding to a vaccine, this may be a useful early signal that the vaccine will be successful.
Objective:
To examine how immune cells respond to COVID-19 infection.
Eligibility:
Adults ages 18 and older who have a confirmed or suspected COVID-19 infection or had COVID-19 in the past.
Also, healthy donors with no suspected COVID-19 infection
Design:
Participants will be screened with medical record review.
Participants will be tested with a research assay to determine who was infected with COVID-19 and who was not. This test will be used to understand research results, not to advise patients.
Participants with active infection must be isolated, usually in a hospital.
Other participants may give blood samples at NIH or at their local doctor s office or lab.
Participants may give blood samples up to three times a week for a total of ten times, and may also give blood samples after starting a vaccine trial.
Participants will be contacted by phone or email every 2 months for up to 2 years.
详细描述
Background:
Patients infected with COVID-19 have an unpredictable risk to worsen and die, making it difficult to decide who can quarantine at home and who should be monitored for respiratory failure as an inpatient. This risk may be related in part to the patient s immune response which can be characterized with respect to the B- and T-cell repertoire. Determining patterns of immune response which correlate with clinically effective immunity may help in determining risk.
Patients receiving a vaccine for COVID-19 are tested for antibody production, but ultimately protection from infection and survival are the most important endpoints, which will take time. If patients can be checked for a pre-defined favorable pattern of immune response, it may significantly speed selection of effective candidate vaccines.
In patients with hematologic malignancies, including patients with hairy cell leukemia (HCL) who we have extensive experience treating, we do not know if we should be steering away more from treatments which harm B-cell immunity, like rituximab or obinutuzumab, or steering away more from treatments which harm T-cell immunity, like purine analogs. Characterizing the immune response in COVID-19 patients will quickly answer this question.
Objective:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Characterize immune response
时间窗: Ongoing
characterize immune response in patients with active or prior COVID-19 infection
次要结局
- Immune response and outcome(ongoing)
- B- and T-cell arm immune response(ongoing)