Novel Adoptive Cellular Therapy With SARS-CoV-2 Specific T Cells in Patients With Severe COVID-19
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Success rate in production of SARS-CoV-2 specific T cells from convalescent donor
研究概览
简要总结
The overall objective of this project is to develop an emergent treatment protocol using adoptive T-cell therapy for the treatment of severe COVID-19. The central hypothesis is that SARS-CoV-2 specific T cells from convalescent donors who have recovered from COVID-19 can be manufactured expeditiously for the treatment of severe SARS-CoV-2 infections.
详细描述
A novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of Coronavirus Disease 2019 (COVID-19). Currently, no vaccine or specific treatment has been proven to be effective. While waiting for vaccine to be developed, passive immunity can be acquired immediately by adoptive transfer of SARS-CoV-2 specific T cells from convalescent donors into newly infected patients.
The aim of this protocol is to demonstrate the feasibility of preparing SARS-CoV-2 specific T cells from convalescent donors for urgent clinical use. The specific hypothesis is that SARS-CoV-2 specific T cells can be isolated from the blood of convalescent donors rapidly and efficiently using SARS-CoV-2 specific peptides and an automated medical device for emergent treatment of severe COVID-19 disease.
A minimum of 8 convalescent donors will be recruited from Singapore to attain HLA sharing with at least 90% of the general population.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 to 65
- •Had a history of COVID-19 with documented positive test for SARS-CoV-2 in the past
- •Has recovered from COVID-19 and is now suitable for blood donation, fulfilling all standard blood donor criteria
- •Negative test for SARS-CoV-2 currently
排除标准
- •Do not meet the standard criteria for blood cell donation at National University Hospital or Singapore General Hospital.
结局指标
主要结局
Success rate in production of SARS-CoV-2 specific T cells from convalescent donor
时间窗: Two weeks (The expected duration of donor participation is 2 weeks)
Success of SARS-CoV-2 specific T cell manufacturing is defined as production of \>200,000 T cells per donor. The success rate will be summarized descriptively.
次要结局
未报告次要终点