NCT04343755终止2 期
Phase IIa Study Exploring the Safety and Efficacy of Convalescent Plasma From Recovered COVID-19 Donors Collected by Plasmapheresis as Treatment for Hospitalized Subjects With COVID-19 Infection
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Number of Participants Hospitalized for COVID-19 But Not Intubated
研究概览
简要总结
- This is a single arm phase IIa study of convalescent plasma for the treatment of individuals hospitalized with COVID-19 infection.
- Subjects will be considered as having completed the study after 60 (+/- 3) days, unless consent withdrawal or death occurs first.
- Interim analysis will be permitted as described in the statistical section 8.
- The final analysis will be conducted once the last subject completes the day 60 visit or withdraws from the study.
详细描述
Overall study design
- This is a single arm phase IIa study of convalescent plasma for the treatment of individuals hospitalized with COVID-19 infection.
- Subjects will be considered as having completed the study after 60 (+/- 3) days, unless consent withdrawal or death occurs first.
- Interim analysis will be permitted as described in the statistical section 8.
- The final analysis will be conducted once the last subject completes the day 60 visit or withdraws from the study.
Number of subjects
• Up to 36 patients in track 2, and 19 patients in track 3 as described in the statistical section 8.
Overall study duration
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
- •Donor Eligibility Criteria:
- •Age 18-60
- •A history of a positive nasopharyngeal swab for COVID-19 or a history of positive titer test.
- •At least 14 days from resolution of COVID-19-associated symptoms including fevers
- •One negative nasopharyngeal swabs for COVID-19 RNA
- •Covid-19 neutralizing antibody >1:64
- •Adequate venous access for apheresis
- •Meets donor eligibility criteria in accordance to Hackensack University Medical Center (HUMC) Collection Facility at the John Theurer Cancer Center (JTCC) if collecting at the JTCC, and all regulatory agencies as describes in SOP 800 01 (Appendix A)
- •Required testing of the donor and product must be performed in accordance to FDA regulations (21 CFR 610.40), and the donation must be found suitable (21 CFR 630.30)
- •Recipient Eligibility Criteria:
- •Recipients age >18 years old, are assigned to one of two clinical tracks, track 2 or 3, based on COVID-19 disease severity. Onset of first symptoms < 9 days.
- •Hospitalized, moderate symptoms requiring medical care for COVID-19 infection
- •Symptoms may include fever, dyspnea, dehydration among others
- •Hypoxemia may be present but is not a requirement
- •Requiring mechanical ventilation for the care of COVID-19 infection
- •Requiring non-invasive positive pressure ventilation (NIPPV), such as continuous airway pressure (CPAP),bi-level positive airway pressure (BiPAP) or high flow nasal canula (HFNC).
排除标准
- •History of severe transfusion reaction to plasma products
- •Infusion of immune globulin within the previous 30 days
- •AST or ALT > 10 x upper limit of normal
- •Requirement for vasopressors
- •COVID-19-associated acute kidney injury requiring dialysis
- •DNR status
研究组 & 干预措施
Convalescent Plasma
Experimental
Fresh or frozen plasma will be infused one time to patients
干预措施: Convalescent Plasma (Biological)
结局指标
主要结局
Number of Participants Hospitalized for COVID-19 But Not Intubated
时间窗: 7 Days
Mechanical ventilation rate at 7 days from starting treatment in hospitalized COVID-19 patients
Primary Objective for Patients With COVID-19 Already Intubated
时间窗: 30 Days
Mortality rate at 30 days from starting treatment for patients with COVID-19
次要结局
- Duration of Mechanical Ventilation(60 Days)
- Overall Survival(60 Days)
- Rate of Virologic Clearance by Nasopharyngeal Swab at Day 10(10 Days)
- Recipient Anti-SARS-CoV2 Titer Assessment on Day 10(10 Days)
- Recipient Anti-SARS-CoV2 Titer Assessment on Day 30(30 Days)
- Recipient Anti-SARS-CoV2 Titer Assessment on Day 60(60 Days)
- Time to Symptoms Resolution(60 Days)
- Rate of Virologic Clearance by Nasopharyngeal Swab at Day 30(30 Days)
- Impact of Donor Titers Level on Efficacy(60 Days)
- Duration of Hospitalization(60 Days)
- Impact of Donor Titers Level on Safety(60 Days)
- Recipient Anti-SARS-CoV2 Titer Assessment on Days 0 (Pre-infusion)(0 Days (pre-infusion))
- Recipient Anti-SARS-CoV2 Titer Assessment on Days 3(3 Days)
研究者
研究点 (1)
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