A Randomized, Open-label, Adaptive, Proof-of-concept Clinical Trial of Donated Antibodies Working Against With COVID-19: DAWN-PLASMA
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 483
- 试验地点
- 21
- 主要终点
- Patients requiring mechanical ventilation or death
研究概览
简要总结
This a phase II, proof-of-concept study. In the present study, we investigate if the administration of blood-plasma from patients recovered from COVID-19, could be effective to treat patients who are severely ill because of a COVID-19 infection. The general idea behind the transfusion, is that plasma of recovered patients contains antibodies that could eliminate the novel coronavirus causing COVID-19, and lead to a less severe course of the disease, or a faster healing. Simply put, in this study we would like to investigate whether 'borrowed immunity' from a person who has cured from this disease, could be applied to cure other patients more rapidly.
详细描述
In December 2019, a new coronavirus (the SARS-CoV-2 virus) emerged, which spread fast across the world, and has led to a pandemic. The disease caused by this virus, called COVID-19, has a mild course in a high number of infected people, but is known to have a more severe course in some. Currently, there are no successful treatments with a known effect on the course of the disease in patients suffering from COVID-19. In this study, we will examine whether plasma, a treatment that has been used in human subjects for other diseases (and is known to be safe), can be used to influence the course of COVID-19 towards a lower severity.
The aim of the study is to evaluate clinical efficacy and safety of convalescent plasma for COVID-19.
This clinical trial is an adaptive, randomized, open-label phase II proof-of-concept study to investigate the safety and effect of potentially interesting treatments, for the treatment of hospitalized adult patients suffering from COVID-19.
Because an active treatment for COVID-19 is lacking, plasma donation is now being proposed. To investigate this effect of plasma, we will compare two groups of patients. One group will get standard treatment, plus plasma from a patient recently cured from COVID-19. A second group will get standard treatment alone. In this study, 2 patients out of 3 will receive plasma, and 1 patient out of 3 will receive standard treatment alone. After the study, we will be able to establish whether plasma donation is useful or not.
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
- •Subject (≥18 years old) or legally authorized representative provides informed consent prior to initiation of any study procedures.
- •Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.
- •Male or non-pregnant female adult ≥18 years of age at time of enrolment.
- •Patient should be hospitalized
- •Has a confirmed diagnosis of SARS-CoV-2 infection, defined as either:
- •laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen as diagnosed within 60 hours prior to randomization or
- •The combination of upper or lower respiratory infection symptoms (fever, cough, dyspnea, desaturation) and typical findings on chest CT scan and absence of other plausible diagnoses
- •Illness of any duration, and at least one of the following:
- •Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), or
- •Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤ 94% on room air, or
- •Requiring supplemental oxygen.
- •ABO D typing of the patient should be done at least once and the result should be known.
排除标准
- •Receiving invasive (any mode where a patient has been intubated endotracheally, or via tracheostomy) or non-invasive (for instance, but not restricted to CPAP, PSV, PCV, SiMV) mechanical ventilation before or upon randomization.
- •Pregnancy or breast feeding.
- •Any medical condition which would impose an unacceptable safety hazard by participation to the study.
- •Patients with a documented grade 3 allergic reaction after the administration of fresh frozen plasma (i.e. systemic reaction with cardiovascular and/or respiratory involvement)
- •Patients that have treatment restriction that excludes mechanical ventilation and/or endotracheal intubation
- •Rituximab or another anti-CD20 monoclonal antibody (f.ex. obinutuzumab) has been administered during the year prior of the date of admission.
研究组 & 干预措施
Convalescent Plasma
4 units of convalescent plasma:
- 2 units of plasma are administered within 12h after randomization, but preferably as soon as practically possible
- 2 units of plasma should be administered between 24h and 36h after the first infusion
干预措施: Convalescent Plasma (Biological)
Convalescent Plasma
4 units of convalescent plasma:
- 2 units of plasma are administered within 12h after randomization, but preferably as soon as practically possible
- 2 units of plasma should be administered between 24h and 36h after the first infusion
干预措施: Standard of care (Drug)
Standard of Care
Since there are no current approved treatment options for COVID-19, the standard of care is mostly supportive. Since there are no current approved treatment options for COVID-19, the standard of care is mostly supportive.
干预措施: Standard of care (Drug)
结局指标
主要结局
Patients requiring mechanical ventilation or death
时间窗: No mechanical ventilation at day 15 after hospitalization.
Primary outcome of the study is the number of patients alive without mechanical ventilation at day 15 after hospitalization.
次要结局
- Clinical status of subject at day 15 and day 30 (on a 10-point "WHO progression" ordinal scale)(day 15 and day 30)