跳至主要内容
临床试验/NCT05000307
NCT05000307已完成不适用

Co-Sér: Serological Analysis and Viral Neutralization in People With a Documented COVID-19

University Hospital, Ghent2 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2020年7月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
79
试验地点
2
主要终点
Neutralising capacity of naturally produced antibodies against SARS-CoV2

研究概览

简要总结

In light of the current coronavirus disease 2019 (COVID-19) pandemic, the investigators want to better study the immunological characteristics of Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS-CoV2) infections in adults. The investigators invite volunteers to participate in a clinical study to better understand what happens after an infection with SARS-CoV2. By collecting and analysing blood samples of people that were infected, the investigators want to evaluate whether or not the participants had an adaptive immune response with the producting of immunoglobulin. The investigators will evaluate the quality of the antibodies and their neutralising capacity. In a selected patient group with strong antibody response, the investigators will try to reproduce them in the lab after the collection of a larger blood sample (max 72 mL) of, in case of insufficient B-cells, a leucapheresis (after consent of the patient). These antibodies can be used in clinical trials to evaluate whether the investigators can cure patients faster or prevent disease by the utilisation of these antibodies.

Aside from the aforementioned information the investigators will also collect clinical data such as: demographic information, medical history, routine lab results, radiographic imaging and medication use.

After the completion of the study, the samples will be stored for 30 years with consent of the participants.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

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

入选标准

  • Evidence of prior COVID-19 infection, documented by polymerase chain reaction (PCR) or antibody testing (IgG based)

排除标准

  • Known pregnancy at the time of screening
  • Patient is on immunosuppressive therapy or was treated with immunosuppressive therapy during the last 6 months
  • Inability to give informed consent or absence of legal representative who can give informed consent.

结局指标

主要结局

Neutralising capacity of naturally produced antibodies against SARS-CoV2

时间窗: 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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