An Open Label Trial of Transfusion of COVID-19 Convalescent Plasma (CCP) to Patients With Moderate to Severe COVID-19
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Change in intubation status after CCP transfusion.
研究概览
简要总结
This research study evaluates the safety and effectiveness for the use of convalescent plasma transfusion as a treatment option for novel coronavirus SARS-CoV-2 infection (COVID-19). Donors who have recovered from COVID-19 with high antibody levels to the CoV-2 virus will donate plasma at a Mississippi Blood Services facility. Recipients with COIVD-19 who have severe or life threatening conditions will receive plasma from those persons who have recovered from COVID-19.
详细描述
The research purpose is to evaluate the safety and clinical effectiveness of transfusing one unit of banked plasma obtained from patients who have recovered from the novel coronavirus SARS-C0V-2 infection with high titers of IgG antibody to this virus transfused into patients with severe or at high risk of progressing to severe coronavirus-induced disease (COVID-19).
The research hypothesis is that COVID-19 convalescent plasma (CCP) transfusion improves outcomes in patients with COVID-19.
The use of CCP to treat serious and life threatening COVID-19 has a sound biological as well as clinical rationale to provide virus-specific immune protection in patients unable to produce and/or maintain antiviral antibodies. This treatment protocol is designed primarily to offer a rescue therapy in patients with severe and life threatening disease and explore use in patients for whom a progression to serious disease is likely. Examining the specific antibody responses to the virus in transfused patients if/when they show signs of recovery and comparing these values with those obtained before the transfusion may provide information to design more extensive trials aimed at identifying the best patient population for future use of CCP.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinician judged serious or life threatening COVID-19 (or at significant risk to develop serious COVID) manifested by at least one of the following:
- •Laboratory confirmed diagnosis of SARS-CoV-2 infection
- •Hypoxia (PaO2/FiO2 <300, Pulse oximetry <93% at rest
- •Evidence of pulmonary infiltration
- •Respiratory failure
- •Multiple organ dysfunction or failure (assessed by SOFA score)
- •Informed consent provided by the patient or legally authorized representative (LAR)
排除标准
- •Greater than 21 days from confirmed COVID-19 diagnosis
- •Receipt of pooled immunoglobulin transfusion in previous 28 days
- •History of prior reaction to transfused blood products
- •Currently enrolled in other drug trials that preclude investigational treatment with CoV-2 convalescent plasma transfusion
结局指标
主要结局
Change in intubation status after CCP transfusion.
时间窗: 3 Days
Change in pre-transfusion respiratory status compared to Day 3 respiratory status measured by intubation status.
Change in PaO2/FiO2 after CCP transfusion.
时间窗: 3 Days
Change in pre-transfusion respiratory status compared to Day 3 respiratory status measured by PaO2/FiO2.
Change in aO2 after CCP transfusion.
时间窗: 3 Days
Change in pre-transfusion respiratory status compared to Day 3 respiratory status measured by aO2.
Change in respiratory rate after CCP transfusion.
时间窗: 3 Days
Change in pre-transfusion respiratory status compared to Day 3 respiratory status measured by respiratory rate.
Change in pulse oximetry status after CCP transfusion.
时间窗: 3 Days
Change in pre-transfusion respiratory status compared to Day 3 respiratory status measured by pulse oximetry.
次要结局
- Development of plasma transfusion reactions.(Days 1, 3, 7, and 28)
- Length of ICU/hospital stay.(Days 1, 3, 7, and 28)
- Change in Sequential Organ Failure Assessment (SOFA).(Days 1, 3, 7, and 28)
- Change in anti CoV-2 IgM and IgG levels.(Days 1, 3, 7, and 28)
- Change in 8-point ordinal clinical deterioration scale.(Days 1, 3, 7, and 28)
- Development of immune complex disorders.(Days 1, 3, 7, and 28)
研究者
Gailen D. Marshall Jr., MD PhD
Vice Chair for Research, Department of Medicine; Director, Division of Allergy, Asthma and Clinical Immunology
University of Mississippi Medical Center