NCT04456413终止2 期
Phase II Randomized Study of Convalescent Plasma From Recovered COVID-19 Donors Collected by Plasmapheresis as Treatment for Subjects With Early 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
- 21
- 试验地点
- 1
- 主要终点
- Hospitalization Rate
研究概览
简要总结
- This is a phase II randomized study of convalescent plasma for the treatment of non-immune individuals with COVID-19 infection at high risk of complications.
- Subjects will be considered as having completed the study after 2 months (+/- 5) days, unless consent withdrawal or death occurs first.
- Subjects will be randomized to receiving convalescent plasma or best supportive care.
- Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease.
- The final analysis will be conducted once the last subject completes the 2-month visit or withdraws from the study.
详细描述
Overall study design
- This is a phase II randomized study of convalescent plasma for the treatment of non-immune individuals with COVID-19 infection at high risk of complications.
- Subjects will be considered as having completed the study after 2 months (+/- 5) days, unless consent withdrawal or death occurs first.
- Subjects will be randomized to receiving convalescent plasma or best supportive care.
- Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease.
- The final analysis will be conducted once the last subject completes the 2-month visit or withdraws from the study.
A total of 306 subjects will be recruited, 153 for each arm. If a patient in the best supportive care arm requires hospitalization, the patient will be eligible to receive convalescent plasma if requested and/or deemed medically appropriate by the admitting physician.
Overall study duration
- The study begins when the first subject (donor or recipient) signs the informed consent. The study will end once the last enrolled subject completes the study (likely a recipient).
- The expected duration of the study is approximately 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 antibody titer test.
- •At least 14 days from resolution of COVID-19-associated symptoms including fevers.
- •A negative nasopharyngeal swab (or similar test) for COVID-19
- •anti-SARS-CoV2 titers >1:500
- •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
- •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:
- •Patient age >30 years old, newly diagnosed with a COVID-19 infection with onset of first symptoms < 96 hours.
- •And least one other high-risk feature:
- •BMI 30 or above
- •Hypertension, defined as SBP above 140 or DBP above 90, or requiring medication for control.
- •Coronary artery disease (history, not ECG changes only)
- •Congestive heart failure
- •Peripheral vascular disease (includes aortic aneurysm >= 6 cm)
- •Cerebrovascular disease (history of CVA or TIA)
- •Chronic pulmonary disease
- •Liver disease (such as portal hypertension, chronic hepatitis)
- •Diabetes (excludes diet-controlled alone)
- •Moderate or severe renal disease defined as having a GFR < 60 mL/min
- •Cancer (exclude if > 5 year in remission)
- •AIDS (not just HIV positive)
排除标准
- •History of severe transfusion reaction to plasma products
- •Need for oxygen supplementation
- •Positive test for COVID-19 antibodies
- •Chemotherapy-induced neutropenia (ANC < 0.5 x 103/mcL)
- •Immunosuppressive medications except for prednisone (or steroid equivalent) > 10 mg daily.
- •Performance status < 50 by KPS
- •Pneumonia by radiographic evaluation
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)
Best Supportive Care
Active Comparator
Patients will receive best supportive care. Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease.
干预措施: Best Supportive Care (Other)
结局指标
主要结局
Hospitalization Rate
时间窗: 10 Days
The hospitalization rate will be summarized by frequency (%) and compared between the Treatment and Control arms by Mantel-Haenszel test.
次要结局
- Rate of Nasopharyngeal Swab Positivity in Donors(2 Months)
- Overall Survival Rate(2 Months)
- Time to Symptoms Resolution(2 Months)
- Rate of Virologic Clearance by Nasopharyngeal Swab at 2 Weeks(2 Weeks)
- Rate of Donor Titers Level(2 Months)
- Impact of Donor Titers Level on Efficacy(2 Months)
- Patients' Anti-SARS-CoV2 Titer Assessment Pre-infusion for the Treatment Group, at 2 Weeks , 4 Weeks and 2 Months.(Prior to treatment, 2 Weeks, 4 Weeks, and 2 Months)
- Rate of Virologic Clearance by Nasopharyngeal Swab at 4 Weeks(4 Weeks)
研究者
研究点 (1)
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