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临床试验/NCT04794387
NCT04794387已完成不适用

The Lymphoma and Leukemia Society Amended COVID-19 Registry

Lymphoma and Leukemia Society1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2021年8月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,000
试验地点
1
主要终点
A SARS antibody test will be paired with surveys to measure the response people with blood cancer, who did not develop antibodes after a complete COVID-19 vaccination, have to the COVID-19 booster.

研究概览

简要总结

The LLS COVID-19 Registry is being amended to invite people who participated in the LLS COVID-19 Registry and did not develop antibodies after receiving a complete COVID-19 vaccination, as well as people with blood cancer who did not participate in the initial LLS COVID-19 Registry and also did not develop antibodies after receiving a complete COVID-19 vaccination, to participate in this amended LLS COVID-19 Registry.

详细描述

The results of the Leukemia and Lymphoma Society (LLS) COVID-19 Registry indicate that about twenty-five percent (25%) of people with blood cancer and on immunosuppressants participating in the LLS COVID-19 Registry, who received a complete COVID-19 vaccination, did not develop antibodies.

The Food and Drug Administration has authorized third doses (boosters) of the Pfizer and Moderna Covid-19 vaccines for people with weakened immune systems, in a bid to bolster their protection against infection as the highly contagious Delta variant circulates. The agency will amend the emergency-use authorizations for the two vaccines to allow immunocompromised people to get an additional dose.

Therefore the LLS COVID-19 Registry is being amended to invite people who participated in the LLS COVID-19 Registry and did not develop antibodies as noted above, as well as people with blood cancer who did not participate in the initial LLS COVID-19 Registry and also did not develop antibodies after receiving a complete COVID-19 vaccination, to participate in this amended LLS COVID-19 Registry. Using the same design as the initial COVID-19 Registry (Protocol LLSC19-001), this amended LLS COVID-19 Registry will determine if people who have decided to receive a booster vaccination, who did not develop antibodies after receiving a complete COVID-19 vaccination will develop antibodies after a single dose booster of either the Pfizer or Moderna COVID-19 vaccination.

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
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • People with blood cancer who did not develop antibodies after a complete COVID-19 vaccination.

排除标准

  • People who receiived a complete COVID-19 vaccination and did develop antibodies.
  • People unwilling or unable to receive COVID-19 booster.

结局指标

主要结局

A SARS antibody test will be paired with surveys to measure the response people with blood cancer, who did not develop antibodes after a complete COVID-19 vaccination, have to the COVID-19 booster.

时间窗: 10 years

Observational Study

次要结局

未报告次要终点

研究者

发起方
Lymphoma and Leukemia Society
申办方类型
Other
责任方
Sponsor

研究点 (1)

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