An Open-Label, Controlled, Phase 1, Safety and Exploratory Efficacy Study of Convalescent Plasma for Severely Ill, Hospitalized Participants With COVID-19 Pneumonia Caused by SARS-CoV-2.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 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 improves patients' health as compared to not using it in patients with pneumonia caused by SARS-CoV-2.
详细描述
This open-label, randomized, controlled, phase 1 trial will assess the safety and efficacy of convalescent plasma in severely ill, hospitalized participants with pneumonia due to COVID-19. This study will enroll adults 18 years old and older, including pregnant women.
A total of 80 eligible participants will be randomized to receive either 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 and standard of care (treatment arm) or standard of care alone (control arm). Participants in the treatment arm will receive 2 units of convalescent plasma on Study Day 1 in addition to standard of care.
Participants will be assessed on study Day 1 (pre-dose), 30 minutes after each unit of plasma, on all Study Days while hospitalized, and Study Days 15, 22, 29, and 60. All participants will undergo a series of safety and efficacy, assessments. Blood samples will be collected on Days 1 (prior to plasma administration), 3, 8, 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
- Randomized
- 干预模型
- Parallel
- 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 in participating facility.
- •Documentation of pneumonia with radiographic evidence of infiltrates by imaging (e.g., chest x-ray or CT scan).
- •Abnormal respiratory status that is judged worse than baseline by the investigator and as documented at any point within 24 hours prior to randomization, consistent with ordinal scale levels 5, 6 or 7, specifically defined as:
- •Room air saturation of oxygen (SaO2) < 93%, OR
- •Requiring supplemental oxygen, OR
- •Tachypnea with respiratory rate ≥30
- •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. Note: investigational therapies used as part of clinical care, (eg, remdesivir, hydroxychloroquine) are permissible.
研究组 & 干预措施
COVID-19 Convalescent plasma
COVID-19 Convalescent plasma on Study Day 1 in addition to standard care
干预措施: COVID-19 Convalescent Plasma (Biological)
Standard care
Standard care alone
结局指标
主要结局
Participants With Serious Adverse Events.
时间窗: Up to Study Day 29
Number of participants with at least one serious adverse events (SAEs) up to Study Day 29.
Clinical Severity Score
时间窗: Up to Study Day 29
Clinical Severity Score (CSC) measured by both survival time, time to recovery (defined by reaching levels 1-3 of the WHO modified 8-Point Ordinal Severity scale), and disease course while hospitalized and is calculated based on a procedure proposed by Shaw and Fay 2016 (https://doi.org/10.1002/sim.6950). CSC ranges from 1 to 57. Higher CSC is worse outcome. Clinical status assessment (WHO modified 8-Point Ordinal Severity scale) includes: 1. Not hospitalized, no limitations on activities. 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death
次要结局
- Oxygenation(Daily while hospitalized and up to Study Day 29)
- Duration of Non-invasive Ventilation/High Flow Oxygen up to Day 29(Daily while in hospital to Study Day 29.)
- Number of Subjects With SAEs Through Day 29(Through Study Day 29)
- Duration of Hospitalization(To Study Day 29)
- Duration of New Oxygen Use up to Day 29(From enrollment to Day 29.)
- Number of Participants With at Least One Day on Non-invasive Ventilation/High Flow Oxygen up to Day 29(Daily while in hospital until Study Day 29)
- New Mechanical Ventilation or ECMO Use(From enrollment to Day 29.)
- Duration of New Mechanical Ventilation or ECMO(Daily while in hospital to Study Day 29)
- Clinical Status Assessment, Time to Recovery(Up to Study Day 29)
- National Early Warning Score (NEWS) Clinical Status Assessment(Up to Study Day 29)
- Non-invasive Ventilation/High Flow Oxygen Days up to Day 29(Daily while in hospital to Study Day 29.)
- Ventilator/ECMO Days to Day 29(Daily while in hospital to Study Day 29)
- Mortality(28 days from Study Day 1)
- Changes in Glucose Measurement Through Day 29(Through Day 29.)
- Incidence of New Oxygenation Use up to Day 29(From enrollment to Day 29.)
- Changes in WBC With Differential Through Day 29(Through Day 29)
- Changes in Platelets Measurement Through Day 29(Through Day 29.)
- Changes in Creatinine Measurement Through Day 29(Through Day 29.)
- Changes in Total Bilirubin Measurement Through Day 29(Through Day 29)
- Changes in ALT Measurement Through Day 29(Through Day 29)
- Number of Subjects With at Least One Grade 3 and Grade 4 Clinical and/or Laboratory Adverse Events Through Day 29(Through Study Day 29)
- Changes in Hemoglobin Measurement Through Day 29(Through Day 29)
- Changes in AST Measurement Through Day 29(Through Day 29.)
- Changes in PT Measurement Laboratory Through Day 29(Through Day 29.)