Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients - CORIMUNO-CORIPLASM : EFFICACY OF CONVALESCENT PLASMA TO TREAT SARS-COV2 INFECTED PATIENTS
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Survival without needs of ventilator utilization or use of immunomodulatory drugs (other than steroids)
研究概览
简要总结
The coronavirus disease 2019 (COVID-19) viral pneumonia is now a worldwide pandemic caused by the Severe acute respiratory virus coronavirus 2 (SARS-CoV-2). The number of cases, and associated mortality has increased dramatically since the first cases in Wuhan, China in December 2019 . To date, no specific treatment has been proven to be effective for COVID-19. Treatment is currently mainly supportive, with in particular mechanical ventilation for the critically ill patients (6.1% in a series of 1099 cases in China). Novel therapeutic approaches are in acute need. In this context, the therapeutic potential associated with convalescent plasma needs to be explored.
The objective of COVIPLASM trial (a nested trial in the CORIMUNO-19 COHORT) is to study the efficacy of convalescent plasma to treat SARS-COV2 infected patients.
详细描述
Hypothesize: early administration of convalescent plasma containing polyclonal neutralizing Abs may inhibit viral entry and replication (as recently suggested in vitro) and consequently blunt an early pro-inflammatory pathogenic endogenous Ab response.
Potential donors of convalescent plasma will be identified through various means, including hospitals taking care of such patient, practitioners treating outpatients or specific social messaging. Convalescent patients at least 14 to 28 days (per at date regulation regarding blood donation) after the symptoms resolution will be invited to undergo plasma apheresis, pending general eligibility such as an age between 18 and 65 years old and weight not less than 50 kg.
Two convalescent plasma units of 200 to 220 ml each will be transfused i.v. as early as possible and no later than 10 days after onset of clinical symptoms. In the absence of acute unforeseen adverse events in the first 3 patients, an additional 2 plasma units of 200/220 ml each will be transfused 24 hours after first 2 units: a total of 4 units / patient. Transfusion monitoring, treatment and reporting of adverse events will be performed per ANSM hemovigilance regulation regarding transfusion of labile blood products as well as through the specific clinical trial vigilance.
An average of 120 participants will be expected (60 participants in each arm). Availability of ABO compatible plasma will be checked by investigator when a Corimmuno patients is eligible. If so, randomization will be undertaken and patient will be offered to participate in this nested trial if he is allocated to the experimental arm.
An interim analysis is performed at mid-trial, but inclusions are not frozen to wait for the interim analysis.
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
- •Patients included in the CORIMUNO-19 cohort
- •Onset of COVID19 functional signs <8 days (plasma transfusion may occur up to day 10 of onset)
- •Mild severity as described in the WHO scale
排除标准
- •Pregnancy
- •Current documented and uncontrolled bacterial infection.
- •Prior severe (grade 3) allergic reactions to plasma transfusion
研究组 & 干预措施
COVID-19 convalescent plasma
A plasma unit provided by a COVID-19 convalescent pathogen-reduced plasma will be used for the treatment of the patients.
干预措施: Transfusion of COVID-19 convalescent plasma (Drug)
结局指标
主要结局
Survival without needs of ventilator utilization or use of immunomodulatory drugs (other than steroids)
时间窗: At day 14 after randomization
Survival without needs of ventilator utilization (including non- invasive ventilation, NIV) or use of immunomodulatory drugs at day 14 of randomization (WHO score \< 6) or additional immunomodulatory treatment (other than steroids). Thus, events considered are the need of ventilator use (including non invasive ventilation, NIV, or use of immunomodulatory drugs), or death.
WHO progression scale ≥6
时间窗: at day 4 of randomization
WHO progression scale ≥6 at day 4 of randomization
次要结局
- WHO progression scale(at 4, 7 and 14 days after randomization)
- Time to oxygen supply independency(Time until oxygen supply independency up to 28 days)
- Survival without use of immunomodulatory drugs(At day 14 after randomization)
- Severe adverse events(up to 28 days)
- Overall survival(at 14 and 28 days after randomization)
- Time from randomization to discharge(Time until discharge up to 28 days)
- Survival without needs of ventilator utilization(At day 14 after randomization)