A Prospective, Randomized, Placebo-controlled, Double-blinded, Phase III Clinical Trial of the Therapeutic Use of Convalescent Plasma in the Treatment of Patients With Moderate to Severe COVID-19
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 102
- 试验地点
- 4
- 主要终点
- Clinical Improvement
研究概览
简要总结
A prospective, randomized, placebo-controlled, double-blinded, phase III clinical trial of the therapeutic use of convalescent plasma in the treatment of patients with moderate to severe COVID-19
详细描述
Full Title: A prospective, randomized, placebo-controlled, double-blinded, phase III clinical trial of the therapeutic use of convalescent plasma in the treatment of patients with moderate to severe COVID-19.
Short Title: PROTECT-Patient study
Aim: Assess the safety and efficacy of COVID-19 convalescent plasma (CCP) as a therapeutic treatment for hospitalised patients with moderate to severe COVID-19
Study Design: Randomised, double-blinded, placebo-controlled, phase III clinical trial
Intervention: Randomised 1:1 to either CCP plus standard of care (SOC) or to SOC plus placebo (200 mL normal saline)
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Neither participants nor the investigators will be aware of the participant's treatment allocation until the end of the study (double blinding). Blinding will be maintained by local blood bank preparing the appropriate IP and Placebo. Unmasking procedures are detailed by SOP
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
- •Laboratory confirmed SARS-CoV-2 by positive RT-PCR on any respiratory sample;
- •Age ≥ 18 years;
- •Require hospital admission for COVID-19 pneumonia as defined by the presence of pulmonary infiltrates on chest x-ray;
- •Moderate to severe Covid-19 disease, defined as: SpO2 ≤ 93% on room air; plus requiring non-invasive oxygen therapy (WHO R&D BOSCI 4 or 5
- •Signed informed consent;
- •Pregnant women will be allowed to participate.
排除标准
- •Current participation in another therapeutic clinical trial for COVID-19;
- •Invasive mechanical ventilation;
- •Expected survival < 24 hours based on clinical assessment (however, the study does not exclude critically ill patients who are not, due to resource limitations, candidates for critical care admission and/or mechanical ventilation);
- •Known hypersensitivity to immunoglobulin or any components of the formulation;
研究组 & 干预措施
Arm 1
A single unit of approximately 200-250 mL of CCP that contains anti-SARS-CoV-2 collected by plasmapheresis from a volunteer who recovered from COVID19 with SOC as determined by local practice and guidelines.
干预措施: COVID-19 convalescent plasma (CCP) plus standard of care (SOC) (Biological)
Arm 2
A single unit of 200 mL normal saline with SOC as determined by local practice and guidelines.
干预措施: Standard of care (SOC) plus placebo (Biological)
结局指标
主要结局
Clinical Improvement
时间窗: Day 28
Proportion of participants with successful treatment outcome, defined as clinical improvement (≥ 2 points on WHO R\&D BOSCI 1) by Day 28 post-randomisation.
次要结局
- Fever & Hypoxia(Day28)
- Inflammatory markers(Day28)
- Radiography(Day28)
- patients with HIV infection and other comorbidities(Day 28)
- Timing of IP & Efficacy Outcome(Day 28)
- Neutralising Ab(Day28)
- SARS CoV Antibody titre(Day28)
- Adverse Events of special interest(Day 28)
- Serious Adverse Events(Day 28)
- Survival(Day 28)
- Invasive mechanical ventilation(Day 28)
- Disease severity(Day 28)
- Time to outcomes of interest(Day28)
- Length of stay meausures(Day28)
- SARS-CoV PCR(Day28)
研究者
Riana Cockeran
Site Principal Investigator
South African National Blood Service