Assessment of the Effect of Convalescent Plasma Therapy in Patients With Life-threatening COVID19 Infection
试验速览
- 阶段
- 1 期
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Duration of hospitalization/Recovery status
研究概览
简要总结
- This clinical trial proposal is based on the FDA protocol for emergency use of convalescent plasma for treatment of COVID-19 cases, and on the WHO guidelines for use of convalescent plasma in other infectious diseases.
- This Clinical trial is to be applied in Cairo University quarantine hospital. The collection, testing and storage of convalescent plasma will be done inside CUH main blood bank.
The concept of this clinical trial is built on the collection of convalescent plasma from individuals who had recovered from documented infection with SARS-CoV-2, to be used for patients with- or at high risk of progression to- severe/life-threatening clinical conditions due to SARS-CoV-2 infection.
An informed consent is required to join this clinical trial; patients will be transfused with one or two units of ABO compatible convalescent plasma. Those patients will be followed up and the clinical and laboratory data will be compiled, including adverse events related to the administration of convalescent plasma (CP).
Other data to be collected retrospectively will include patient demographics, acute care facility resource utilization (total length of stay, days in ICU, days intubated, and survival till discharge from an acute care facility).
详细描述
This study will be done inside Cairo university hospitals, it will involve a number of CP donors who were recovered from COVID-19 infection and were treated at Cairo University isolation hospital. The CP donation process will take place at CUH blood bank ,the number of the donors will be determined at the end of the study as it will vary according to the donation process .
The study will also include sixty seven /life threatening COVID-19 patients admitted to Cairo University isolation hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must have laboratory confirmed COVID-19 and admitted to Cairo University isolation hospital.
- •Admitted to acute care facility.
- •Must have severe or immediately life-threatening COVID-19:
- •Severe disease is defined as:
- •respiratory frequency ≥ 30/min,
- •blood oxygen saturation ≤ 93%,
- •partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300, and/or
- •lung infiltrates > 50% within 24 to 48 hours (CT finding)
- •Life-threatening disease is defined as:
- •respiratory failure,
- •septic shock, and/or
- •multiple organ dysfunction or failure
排除标准
- •Pregnancy
- •Autoimmune disorder
- •Participated in a CP trial in the past 6 months
研究组 & 干预措施
STANDARD OF COARE
Receiving SOC
干预措施: Standard of Care (Drug)
STANDARD CP DOSE Adm (Two infusions)
Two infusions 48 hours apart
干预措施: Convalescent Plasma (Biological)
STANDARD CP DOSE Adm (Two infusions)
Two infusions 48 hours apart
干预措施: Standard of Care (Drug)
结局指标
主要结局
Duration of hospitalization/Recovery status
时间窗: 2-3 weeks
Decrease of hospital days of safety until discharge
次要结局
未报告次要终点
研究者
Nermeen El Desouky
PROFESSOR OF CLINICAL PATHOLOGY
Cairo University