An Open-Label, Single Arm, Phase 1, Safety and Exploratory Efficacy Study of Convalescent Plasma for Severely Ill Mechanically Ventilated Participants With COVID-19 Caused by SARS-CoV-2
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Participants With Serious Adverse Events.
研究概览
简要总结
The purpose of this study is to see if this plasma can be safely used in humans with COVID-19 and to see if it can improve patients' health when they are sick with COVID-19.
详细描述
This open-label, single arm, phase 1 trial will assess the safety and efficacy of convalescent plasma in severely ill, mechanically ventilated participants with pneumonia due to COVID-19. This study will enroll adults 18 years old and older, including pregnant women. A total of 50 eligible participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19. Participants will receive convalescent plasma on Study Day 1 in addition to standard of care. Participants will be assessed daily while hospitalized and then on Study Days 15, 22, 29, and 60. All participants will undergo a series of safety, efficacy, and laboratory assessments. Blood samples will be collected on Days 1 (prior to plasma administration), 3, 5, 8, 11, 15, 29, and 60. Oropharyngeal or endotracheal samples will be collected on Days 1 (prior to plasma administration), 3, 5, 8, 11, and 15.
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
- •Adult ≥18 years of age
- •Laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other authorized or approved assay in any specimen collected within 72 hours prior to enrollment. Note - An exception must be requested to the Sponsor if≥72 hours since positive test.
- •Hospitalized, on invasive mechanical ventilation or ECMO, consistent with a clinical status assessment 8-point ordinal scale severity score of
- •Documentation of pneumonia with radiographic evidence of infiltrates by imaging (e.g., chest x-ray or CT scan).
- •Patient or proxy is willing and able to provide written informed consent and comply with all protocol requirements.
排除标准
- •Contraindication to transfusion (e.g., severe volume overload, history of severe allergic reaction to blood products), as judged by the investigator.
- •Clinical suspicion that the etiology of acute illness (acute decompensation) is primarily due to a condition other than COVID-19
- •Receipt of other investigational therapy as a part of another clinical trial. a. Note: investigational therapies used as part of clinical care, (eg, remdesivir, hydroxychloroquine) are permissible.
结局指标
主要结局
Participants With Serious Adverse Events.
时间窗: Up to Study Day 29
Cumulative incidence of participants with at least one serious adverse events (SAEs) at Study Day 29.
Time to Clinical Improvement.
时间窗: Up to Study Day 29
Time to removal from mechanical ventilation.
次要结局
- Oxygenation(Daily while hospitalized up to Study Day 29.)
- Duration of Non-invasive Ventilation/High Flow Oxygen up to Day 29 of Convalescent Plasma Administration.(Daily while in hospital to Study Day 29.)
- Incidence of New Oxygenation Use up to Day 29 of Convalescent Plasma Administration(From enrollment to Day 29.)
- Non-invasive Ventilation/High Flow Oxygen Days up to Day 29 of Convalescent Plasma Administration.(Daily while in hospital to Study Day 29.)
- Changes in Creatinine Measurement Through Day 29 of Convalescent Plasma Administration.(Through Day 29.)
- Changes in Glucose Measurement Through Day 29 of Convalescent Plasma Administration.(Through Day 29.)
- Incidence of New Mechanical Ventilation or ECMO Use of Convalescent Plasma Administration.(From enrollment to Day 29.)
- Changes in Total Bilirubin Measurement Through Day 29 of Convalescent Plasma Administration.(Through Day 29.)
- Changes in ALT Measurement Through Day 29 of Convalescent Plasma Administration.(Through Day 29.)
- Number of Subjects With at Least One Day of Non-invasive Ventilation/High Flow Oxygen up to Day 29 of Convalescent Plasma Administration.(Daily while in hospital to Study Day 29.)
- Duration of New Mechanical Ventilation or ECMO Use of Convalescent Plasma Administration.(From enrollment to Day 29.)
- Changes in Hemoglobin Measurement Through Day 29 of Convalescent Plasma Administration.(Through Day 29.)
- Clinical Status Assessment, Using 8-point Ordinal Scale, of Convalescent Plasma Administration(Up to Study Day 29)
- Clinical Status Assessment Using the National Early Warning Score (NEWS) of Convalescent Plasma Administration(Up to Study Day 29)
- Duration of New Oxygen Use up to Day 29 of Convalescent Plasma Administration(From enrollment to Day 29.)
- Invasive Ventilation/ Extracorporeal Membrane Oxygenation(ECMO) Days(Daily while in hospital to Study Day 29)
- Serious Adverse Events (SAEs) Through Day 29 of Convalescent Plasma Administration.(Through Study Day 29.)
- Changes in Platelets Measurement Through Day 29 of Convalescent Plasma Administration.(Through Day 29.)
- Changes in AST Measurement Through Day 29 of Convalescent Plasma Administration.(Through Day 29)
- Duration of Hospitalization(To Study Day 29)
- Mortality(28 days from Study Day 1)
- Number of Subjects With at Least One Grade 3 and Grade 4 Clinical and/or Laboratory Adverse Events Through Day 29 of Convalescent Plasma Administration.(Through Study Day 29)
- Changes in WBC With Differential Through Day 29 of Convalescent Plasma Administration.(Through Day 29.)
- Changes in PT Measurement Through Day 29 of Convalescent Plasma Administration.(Through Day 29)