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临床试验/NCT04746092
NCT04746092Unknown不适用

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

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 630 人开始时间: 2021年1月6日最近更新:
适应症

试验速览

阶段
不适用
入组人数
630
试验地点
1
主要终点
Capability of Haemato-oncology patients to generate antibodies against COVID-19 after infection and vaccination.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
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

入选标准

  • 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.

排除标准

  • Irrelevant

结局指标

主要结局

Capability of Haemato-oncology patients to generate antibodies against COVID-19 after infection and vaccination.

时间窗: 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.

次要结局

  • Documentation of the vaccine side effects(14 to 21 days counting since second vaccination is initiated.)
  • Assess COVID19 morbidity rates(12-month follow-up as part of routine clinic visits.)
  • Comparison of antibody formation to COVID19 between haemato-oncology patients and healthy participants(During the results processing phase about a year and a half from the beginning of the study)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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