An Open Label, Phase 2 Study Evaluating the Efficacy and Safety of High-Titer Anti-SARS-CoV-2 Plasma in Hospitalized Patients With COVID-19 Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- Overall Mortality
研究概览
简要总结
This is a Phase II study. This research study is being conducted to use convalescent donor plasma in seriously ill patients who have COVID-19.
详细描述
This is an open label phase 2 trial assessing the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute severe respiratory symptoms from COVID-19. Symptomatic patients with clinical or radiological interstitial COVID-19 pneumonia and within 21 days of onset of symptoms will be enrolled in 2 cohorts - an ICU cohort and a hospitalized non-ICU cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Age ≥ 18 years or older
- •Hospitalized as an in-patient with positive COVID-19 test by PCR
- •Presence of respiratory symptoms with any of severe features as below:
- •Respiratory Rate ≥ 24/min
- •Oxygen Support >3L/min by nasal cannula
- •New onset or worsening of respiratory symptoms with radiologic confirmation of bilateral ground glass opacities that cannot be attributed to another cause
- •Patient / HCPOA must agree to storage of blood specimens for future testing.
- •Patient / HCPOA is willing and able to provide electronic informed consent and comply with all protocol requirements. If patient is unable to consent due to incapacity, health care POA should be defined and able to consent for the patient.
- •Patients are allowed to receive all standard of care. Co enrollment in other clinical trials is permitted.
排除标准
- •FCBP with positive pregnancy test (mandatory)
- •Breastfeeding females
- •Receipt of pooled immunoglobulin (e.g. IVIG or other hyperimmune globulin products) in past 14 days. This does not apply to monoclonal antibodies .
- •Mechanical ventilation for > 14 days
- •Days from symptom onset >21 days
- •Expected survival < 72 hours
- •Contraindication to transfusion or history of prior reactions to transfusion blood products including any proven history of TRALI
- •Patients who were previously admitted to ICU cannot be enrolled in the non-ICU cohort. These patients could need ICU level care subsequently and at that time point could be considered for ICU cohort .
研究组 & 干预措施
ICU Cohort
Patients who are in the ICU at the time of enrollment. Patients will receive anti-SARS-CoV-2 convalescent plasma.
干预措施: anti-SARS-CoV-2 convalescent plasma (Biological)
Non-ICU Cohort
Patients who are NOT in the ICU at the time of enrollment. Patients will receive anti-SARS-CoV-2 convalescent plasma.
干预措施: anti-SARS-CoV-2 convalescent plasma (Biological)
结局指标
主要结局
Overall Mortality
时间窗: Duration of patient hospitalization, sometimes exceeding 60 days
Overall mortality during hospitalization for COVID-19. All patients were followed for the duration of their hospitalization, sometimes exceeding 60 days, through study completion.
次要结局
- Length of Admission After Plasma Infusion(Length of admission for COVID through study follow-up period)
- Length of ICU Stay After Convalescent Plasma Infusion(Length of admission in the ICU for COVID through study follow-up period)
研究者
Mary Beth Graham, MD
Associate Chief, Professor Infectious Disease
Medical College of Wisconsin