Plasma Exchange (PLEX) and Convalescent Plasma (CCP) in COVID-19 Patients With Multiorgan Failure - the COVID PLEX+CCP Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Alive at Day 90th
研究概览
简要总结
This Randomized Control Trial (RCT) proposes combination of extracorporeal cytokine removal by plasma exchange (PLEX) and additional infusion of convalescent plasma (CCP) collected from COVID-19 recovered individuals at the end of the PLEX procedure. The combination of cytokine removal by PLEX and CCP infusion is in onvestigators opinion more rational compared to CCP infusion alone and as such probably more effective in reducing the duration of mechanical ventilation, length of stay in the intensive care unit, and potentially also mortality.
详细描述
Background Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has caused a pandemic of coronavirus disease (COVID-19) with many patients developing severe hypoxia and some multiple organ failure. Many patients have died, and healthcare systems in several countries have been or will be overwhelmed because of a surge of patients needing hospitalisation and intensive care. There is no available proven treatment for COVID-19; the care is supportive, including respiratory, circulatory and renal support. For other patient groups with similar critical illness (acute respiratory disease syndrome and septic shock) multiple inflammatory mediators (cytokines) are linked to and probably responsible for such conditions. Thus, extracorporeal cytokine removal by plasma exchange (PLEX) has been tried in these conditions. Convalescent plasma on the other hand, may offer specific actions against SARS-CoV-2 and COVID-19. With this trial, the investigators will test the use of combined PLEX and infusion of convalescent plasma collected from COVID-19 recovered individuals at the end of the PLEX procedure in the most severely ill patients with COVID-19.
Objectives The investigators will aim to assess the effects of combination of PLEX and convalescent plasma on the number of days alive and out of hospital in adult patients with COVID-19 and multiple organ failure.
Inclusion and exclusion criteria All adult patients who have documented COVID-19 and multiple organ failure will be screened (use of respiratory and renal support). The patients who have received convalescent plasma for COVID-19, who have known hypersensitivity to plasma, who are pregnant, who the clinical team has decided not to escalate therapy, and those in whom informed consent cannot be obtained will be excluded.
Experimental intervention In addition to standard care, 2 plasma exchange procedures within 24 hours by membrane or centrifuge method. Exchange volume of 60 ml of plasma per kg of body weight with Albumin 5% in Ringer/saline as a substitution Fluid 50% at the beginning /Fresh Frozen Plasma 50% towards the end of the session and in addition 2 bags of CCP (equalling 600 ml CCP) with an administration rate of 100 to 250 ml/hr at the end of the 2nd procedure.
Control group with no intervention Standard care without the use of PLEX or convalescent plasma. Outcomes The primary outcome is days alive and out of hospital at day 90. Secondary outcomes are serious adverse events (anaphylactic reaction to CCP, new episode of septic shock or invasive fungal infection); days alive without life support at day 90; and all-cause mortality at day 28 and day 90.
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
- •Confirmed SARS-CoV-2 (COVID-19) requiring intensive care AND - Use of Advanced respiratory support as Invasive mechanical ventilation OR Non-invasive ventilation or continuous use of continuous positive airway pressure (CPAP) for hypoxia OR Oxygen supplementation with an oxygen flow of at least 10 L/min independent of delivery system AND RRT (continuous or intermittent) -OR ECMO
排除标准
- •who have received convalescent plasma for COVID-19,
- •who have known hypersensitivity to plasma,
- •who are pregnant,
- •who the clinical team has decided not to escalate therapy (except that for cardiac arrest; patients who are not for cardio-pulmonary-resuscitation may be enrolled).
- •Who have received RRT for more than 72 hours
- •Who have received mechanical ventilation for more than 14 days
- •We will not exclude patients enrolled in other interventional trials unless the protocols of the two trials collide (e.g. use of CCP by protocol). Co-enrolment agreements will be established with the sponsor/investigator to maintain an updated list of trials approved for co-enrolment (
结局指标
主要结局
Alive at Day 90th
时间窗: 90 days
The primary outcome is days alive and out of hospital from randomisation to day 90.
次要结局
- Day 28 all cause mortality(28 days)
- Day 8 serious adverse events(8 days)
- Days alive without life support at day 90(90 days)
研究者
Wladimir Szpirt
Consultant
Rigshospitalet, Denmark