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临床试验/EUCTR2021-002245-15-DE
EUCTR2021-002245-15-DE进行中(未招募)1 期

A low-interventional study to investigate the efficacy and safety of SARS-CoV-2 vaccines in patients with rheumatic diseases. - VACCIMM

Charité - Universitätsmedizin Berlin0 个研究点目标入组 250 人开始时间: 2021年4月30日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
250

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 1. written consent for study participation.
  • 2. if study entry after first vaccination: written informed consent for analysis of any archived blood samples.
  • 3. males and females = 18 years of age.
  • 4. either arm 1 (AIRD patients): diagnosis of rheumatic autoimmune disease or arm 2 (control group): no diagnosis of rheumatic autoimmune disease.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 2000
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1. persons not capable of giving consent
  • 2. serious illnesses which, in the opinion of the investigator, preclude inclusion or continued observation (for example, tumor diseases requiring intensive chemotherapy).
  • 3. individuals who are unable or unwilling to undergo multiple venipunctures because he/she is intolerant or has poor venous conditions.
  • 4. persons who are admitted to an institution by court order or by order of the authorities.

研究者

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