Viral Specific T-cells (VSTs) for Treatment of SARS-CoV-2/COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Successful production of viral specific T-cells
研究概览
简要总结
The purpose of this research study is to learn more about the use of viral specific T-lymphocytes (VSTs) when given in the presence of COVID-19 signs and symptoms, caused by the virus SARS-CoV-2. VSTs are cells specially designed to fight viral infections. These cells are created from a blood sample collected from a donor who has recovered from COVID-19 infection. VSTs are investigational meaning that they are not approved by the Food and Drug Administration (FDA).
COVID-19 is a new virus and treatment options are evolving rapidly. VSTs have been successfully used to treat many different viral infections and may be beneficial in treating COVID-19 in the absence of other treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have evidence of infection with SARS-CoV-2
- •Patients with symptomatic COVID-19 disease, as defined by at least one of the following
- •Imaging (CXR, CT scan, etc.) with pulmonary infiltrates consistent with COVID-19 infection
- •Requirement for supplemental oxygenation
- •Need for additional respiratory support, including, but not limited to High flow 02, CPAP, BiPAP, Mechanical ventilation
- •Age >1 day
- •Clinical status must allow tapering of steroids to < 0.5mg/kg prednisone or other steroid equivalent
- •Have failed at least one FDA-approved treatment for COVID-19 disease
- •Must be able to receive VST infusion in Ohio (informed consent obtained by CCHMC PI or sub-investigator either in person or by phone)
排除标准
- •Uncontrolled bacterial or fungal infection
- •Uncontrolled relapse of malignancy
- •Unlikely to survive within 48 hours of VST infusion
结局指标
主要结局
Successful production of viral specific T-cells
时间窗: Within 30 days post culture initiation
Of the patients who had a VST culture initiated, successful production of VST cells is defined as meeting the protocol-defined release criteria.
次要结局
- Presence of viral-specific T-cells(At 30 days after infusion)