EUCTR2021-001022-22-GR进行中（未招募）1 期
Generation of SARS-CoV-2-specific T lymphocytes from recovered donors and administration to high-risk COVID-19 patients - COV-2-STs-001
Ge???? ??s???µe?? Tessa??????? Ge?????? ?apa????????0 个研究点目标入组 182 人开始时间: 2021年4月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 182
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
- •· PCR positivity in SARS-CoV-2
- •· Age =18 =80 years
- •· Pneumonia and / or SatO2 =94% in air and / or respiration =24 / min
- •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 109
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 73
排除标准
- •-Age =18 and =80 years old
- •-?o need for hospitalization/ O2
- •-Corticosteroid administration at a dose of >0.75mg/kg (methylprednisolone equivalent)
- •-Multiple organ failure
- •-ARDS (acute respiratory distress syndrome)
- •-Patients who received ATG, or Campath, or other T-cell-suppressing monoclonal antibody within 28 days prior to admission
- •-Patients with concomitant confirmed infection from another pathogen or with very high procalcitonin (PCT) that may indicate additional infection
- •-Enrollment in another clinical trial
- •-Pregnancy
- •-Inability to sign informed consent form (except the case of an intubated patient in which A¨degree relative signs the informed consent form)
- •-Judged ineligible by at the treating physician (treating physician’s discretion)
- •-AST = 3x of upper normal limit
- •-Creatinine = 2x of upper normal limit or with dialysis/hemodialysis needs
研究者
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