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临床试验/JPRN-jRCT1030200279
JPRN-jRCT1030200279暂停未知

Establishment of COVID-19 Convalescent Plasma Banking System in Japan - COVID-CP Banking

Tanosaki Ryuji0 个研究点目标入组 100 人开始时间: 2020年12月25日最近更新:
适应症

试验速览

阶段
未知
状态
暂停
发起方
入组人数
100

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
>= 20age old 至 <= 69age old(—)
性别
All

入选标准

  • (1) Blood type (ABO, Rh type) and irregular antibody are negative (Keio University Hospital)
  • (2) The following infectious disease screening antigen antibody test is negative or within the blood donation standard range: syphilis serological test, hepatitis B virus test (HBs antigen, HBs antibody, HBc antibody), hepatitis C virus test (HCV antibody) ), HIV test (HIV-1, 2 antibody), HTLV-1 antibody test, human parvovirus test, nucleic acid amplification test (HBV, HCV, HIV) (when antibody test of each virus becomes positive) (consigned to Nisseki And carry out)
  • (3) SARS-CoV-2 neutralizing antibody titer (conducted at National Institute of Infectious Diseases Toyama Government Building) is high titer positive (1: 160 or more is a guide).
  • (4) SARS-CoV-2 blood PCR (conducted at the National Institute of Infectious Diseases Murayama Government Building) is negative.

排除标准

  • 1) A clinically meaningful irregular antibody becomes positive,
  • 2) The infectious disease screening is positive or out of the blood donation standard range.
  • 3) SARS-CoV-2 neutralizing antibody titer was judged to be low (1:80 or less is a guideline. Since the criteria are not sufficiently standardized, it will be decided in consultation with the National Institute of Infectious Diseases)
  • 4) SARS-CoV-2 PCR is positive
  • 5) The person in charge of business determines that it is inappropriate

研究者

发起方
Tanosaki Ryuji

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