NCT04751643已完成不适用
Assessment of Therapeutic Plasma Exchange to Improve Respiratory Function by Alleviating Cytokine Storm During Severe Covid-19 Infections Randomised Open-label Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 16
- 主要终点
- Use of intubation and invasive ventilation (IV) between Day 0 (Inclusion Visit) and Day 10
研究概览
简要总结
Severe Covid-19 (Coronavirus Disease 2019) infections generate major but inappropriate production of cytokines and, in some cases, generate anti-IFN (Interferon) auto-antibodies, inducing acute respiratory distress syndrom (ARDS). Therapeutic plasma exchange (TPE) have been reported to be efficient for improving the hyperinflammatory condition state and the respiratory function, which has been described in case reports or small series.
The study aims to remove cytokines during cytokine storm and anti-IFN auto-antibodies (when present) to prevent developpement of an inappropriate immune response and to improve the clinical response to reanimation treatment, in particular the respiratory parameters leading to a rapid improvement of clinical status. To that aim, the study investigates to compare a treatment using TPE plus usual treatments in intensive care unit (experimental arm) versus usual treatments in intensive care unit (routine arm) in a randomised trial.
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
- •Age ≥ 18 years
- •Hospitalized for COVID-19 confirmed by Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) or scanner
- •Patients with PaO2/FiO2 between 75 and 175 mmHg requiring non invasive ventilation or high flow oxygen
- •peripheral venous state allowing PE to be performed, according to the investigator's judgement, or possibility of placing a Sheldon-type veinous central line
- •At least two biological results suggesting a cytokine storm or hyperinflammatory condition state among : C-reactive protéine (CRP)>50mg/L, Procalcitonin (PCT)>1µg/L, Fibrinogen>5g/L, D-dimer >1000ng/mL, Ferritin > 800ng/mL during the last 72 hours.
- •Treatment with corticosteroids (at least 2 intakes of dexamethasone 6 mg or equivalent with another form of corticosteroids)
- •Patient affiliated to a social security or similar scheme
- •Information and written consent from the patient or if not possible from a confident person
排除标准
- •Ventilated intubated patients
- •Patient with advanced cancer and without curative possibility
- •Bacterial or viral (HIV) infection explaining the worsening (the main reason)
- •Body Mass Index > 40
- •Severe hemodynamic instability with mean arterial pressure < 65 mmHg (whatever the noradrenaline dosage used)
- •Known Immunoglobulin A (IgA) deficiency with anti-IgA antibodies
- •Inclusion in another study that could interact with the Covidep study (investigator's judgement)
- •Patient under legal protection measure
- •Pregnant or breastfeeding women
- •In case of allergy to amotosalen (psoralens) or AI-FFP (Amotosalen Inactivated Fresh Frozen Plasma) , use Se-FFP (Secured Fresh Frozen Plasma)
结局指标
主要结局
Use of intubation and invasive ventilation (IV) between Day 0 (Inclusion Visit) and Day 10
时间窗: At day 10
Proportion of patients requiring intubation between Day 0 and Day 10. Intubation use will be measured in both arms at Day 10.
次要结局
- PaO2/FIO2 (Partial Pressure of Oxygen/Fraction of Inspired Oxygen) (mmHg) at day 4 after inclusion (PaO2/FiO2 is a usual parameter for assessing evolution of ARDS)(At Day 4)
- Percentage of patients weaned from non invasive ventilation(At day 10)
- Survival at day 10(At day 10)
- Survival at 2 months(At day 60 (+/- 2 days))
- Percentage of patients without any increase in inflammatory parameters (analysis of C-reactive protein, Fibrinogen,D-Dimers, procalcitonin, Ferritin)(At day 4)
- Variation in cytokine and chemokine levels in the cytokine storm(At day 4)
- Percentage of patients with improved phenotype (decreased phenotype of exhausted cells) and improved function (improved proliferation)(At day 7)
- Percentage of patients with decreased platelet activation(At Day 7)
- Change in anti-IFN auto-antibodies type I (α and ω) level(Day 0 and Day 4)
- Assess the adverse events according to CTCAE v5.0(Throughout the study : Day 1 to Day 10 and to the end of the study (Day 60 +/- 2 days))
- Assess the adverse events according to CTCAE v5.0(Throughout the study : Day 1 to Day 10 and to the end of the study (Day 60 +/- 2 days))
- PaO2/FIO2 (Partial Pressure of Oxygen/Fraction of Inspired Oxygen) (mmHg) at day 4 after inclusion (PaO2/FiO2 is a usual parameter for assessing evolution of ARDS)(At Day 4)
- Percentage of patients weaned from non invasive ventilation(At day 10)
- O2 weaning capacity and duration of O2 dependence(At day 60)
- Survival at day 10(At day 10)
- Survival at 2 months(At day 60 (+/- 2 days))
- Percentage of patients without any increase in inflammatory parameters (analysis of C-reactive protein, Fibrinogen,D-Dimers, procalcitonin, Ferritin)(At day 4)
- Variation in cytokine and chemokine levels in the cytokine storm(At day 4)
- Percentage of patients with improved phenotype (decreased phenotype of exhausted cells) and improved function (improved proliferation)(At day 7)
- Percentage of patients with decreased platelet activation(At Day 7)
- Change in anti-IFN auto-antibodies type I (α and ω) level(Day 0 and Day 4)
研究者
研究点 (16)
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