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The Capability of Haemato-oncology Patients to Generate Antibodies Against COVID-19

2021年8月8日 更新者:Tel-Aviv Sourasky Medical Center

The Capability of Haemato-oncology Patients to Generate Antibodies Against COVID-19 After Infection and Vaccination

The corona pandemic is a continuing global challenge due to Corona Virus 2019 (COVID-19).

The purpose of the study is to evaluate the capability of Haemato-oncology patients to generate antibodies against COVID-19 after infection and vaccination.

研究概览

详细说明

In December 2019, a backlog of patients with respiratory disease was identified in Hubei Province, China. The number of infections increased rapidly, and more patients were identified in other provinces in China, and in various countries in the Far East, Europe and the United States. With few exceptions, patients became infected while staying in China. The cause of the disease has been identified as a virus from the corona family - SARS-CoV-2 and the new name given to the disease. (COVID-19) Coronavirus disease The virus belongs to a family of respiratory viruses that often cause mild respiratory illness, however, viruses from this family have also caused epidemics of severe respiratory infections. On March 11, 2020, the World Health Organization declared the corona virus a global pandemic. The average incubation period (from exposure to the onset of clinical symptoms) is 6 days, with a range of 2 to 11 days. Common symptoms of coronary heart disease include: fever, cough, shortness of breath, muscle aches.Some patients develop complications, including pneumonia, respiratory failure, myocarditis and death. Similar to other respiratory viruses, 2019-nCov is transmitted by respiratory droplets. Diagnosis is made by PCR examination from a sample of the upper respiratory tract (pharynx and nose).

In the literature accumulated in recent months suggests that haemato-oncology patients are at increased risk for severe corona disease and mortality. In haemato-oncology patients the recovery process from corona may be prolonged, including a prolonged secretion of the virus compared to a healthy population.

The study population: CLL, Multiple Myeloma or Lymphoma patients as well control group of healthy patients who are vaccinated with COVID-19 in a commercial preparation, regardless of the study.

Serology test between two and three weeks after the second dose of the vaccine to test the effectiveness of the vaccine will be performed as part of the study .During the follow-up period in patients who have developed antibodies to the virus, patients will be offered to repeat the serological test after six months, irrespectively of whether they received a third vaccine within the Israeli standard of care.

All data collected in the study will be typed into Excel and analyzed using SPSS version 21.0. Continuous data will be described using averages and standard deviations, and categorical data will be described using prevalence and percentages.

研究类型

观察性的

注册 (实际的)

630

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Tel Aviv、以色列、6423906
        • Tel-Aviv Sourasky Medical Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 100年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

CLL, Lymphoma or Multiple Myeloma patients and and their caregivers - healthy participants.

描述

Inclusion Criteria:

  • Age ≥ 18 years old
  • Patient sex - male and female
  • CLL, Lymphoma or Multiple Myeloma patients, in follow up or during an active treatment period, who have recovered from COVID19 (COVID19 recovery defined as the presence of two negative PCR tests), who have been vaccinated against the virus or patients who plan to be vaccinated against COVID19
  • Healthy participants who have been vaccinated against the virus as a control group.

Exclusion Criteria:

  • Irrelevant

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Capability of Haemato-oncology patients to generate antibodies against COVID-19 after infection and vaccination.
大体时间:14 to 21 days counting since second vaccination is initiated.
Evaluate the capability of Haemato-oncology patients to generate antibodies against COVID-19 after infection and vaccination by using serology tests.
14 to 21 days counting since second vaccination is initiated.

次要结果测量

结果测量
措施说明
大体时间
Assess COVID19 morbidity rates
大体时间:12-month follow-up as part of routine clinic visits.
Assess COVID19 morbidity rates in hematologic patients receiving vaccine. patients informs the attending physician in case of diagnosis / infection by COVID 19.
12-month follow-up as part of routine clinic visits.
Documentation of the vaccine side effects
大体时间:14 to 21 days counting since second vaccination is initiated.
Documentation of the vaccine side effects among haemato-oncology patients by questioning patients while taking the blood sample.
14 to 21 days counting since second vaccination is initiated.
Comparison of antibody formation to COVID19 between haemato-oncology patients and healthy participants
大体时间:During the results processing phase about a year and a half from the beginning of the study
Comparison of antibody formation to COVID19 between haemato-oncology patients and healthy participants by comparing their serology tests.
During the results processing phase about a year and a half from the beginning of the study

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Yair Herishanu, Prof.、Tel-Aviv Sourasky Medical Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年1月6日

初级完成 (预期的)

2022年5月24日

研究完成 (预期的)

2022年5月24日

研究注册日期

首次提交

2021年2月2日

首先提交符合 QC 标准的

2021年2月8日

首次发布 (实际的)

2021年2月9日

研究记录更新

最后更新发布 (实际的)

2021年8月16日

上次提交的符合 QC 标准的更新

2021年8月8日

最后验证

2021年2月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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