A Multicenter Randomized Trial to Assess the Efficacy of CONvalescent Plasma Therapy in Patients With Invasive COVID-19 and Acute Respiratory Failure Treated With Mechanical Ventilation: the CONFIDENT Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 475
- 试验地点
- 17
- 主要终点
- Vital status
研究概览
简要总结
The principal objective of the CONFIDENT trial is to assess the efficacy of two units (400-500 mL in total) of convalescent plasma, as compared to Standard of Care (SoC), to reduce day-28 mortality in patients with SARS-CoV-2 pneumonia who require mechanical ventilation.
详细描述
Design : multicenter randomized openlabel, phase II trial.
Number of patients to include : 500 (250 with plasma, 250 without plasma).
The principal objective is to assess the efficacy of the treatment to reduce day-28 mortality in patients with SARS-CoV-2 pneumonia who require mechanical ventilation.
Hypothesis: Passive immunization with plasma collected from patients having contracted COVID-19 and developed specific antibodies may alleviate symptoms and viral load of SARS-CoV-2 and reduce mortality.
The patients will receive currently accepted standard of care for both COVID-19 and usual organ dysfunctions observed in such cases. half the patients will be administered either Convalescent plasma, depending on the randomization process. All patients will be followed-up for one year after inclusion. The study will be considered either positive or negative, based on the principal objective. This means that the product convalescent plasme will be considered effective if mortality at day 28 is lower is patients treated with convalescent plasma than without it. The follow-up will allow to assess a series of secondary objectives, addressing the evolution of organ failures, viral infection, inflammatory response and long-term physical of psychological impact of COVID-19. Interim analyses will be performed every 100 patients included in order to stop the trial if an exceptionally good or bad result is observed, to prevent using or not using the product appropriately in further patients. These analyses will be supervised by an independent committee.
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 at least 18 years
- •hospitalization in an intensive care unit participating to the study
- •medical diagnosis with SARS-CoV-2 pneumonia as defined by both:
- •extended interstitial pneumonia on CT scan or a chest X-ray, consistent with viral pneumonia, within 10 days prior to inclusion
- •Positive result of SARS-CoV-2 PCR test, or any emerging and validated diagnostic laboratory test for COVID-19, within 15 days prior to inclusion
- •under mechanical ventilation administered through an endotracheal tube, for less than 5 days
- •prior Clinical Frailty Scale <
- •written consent of the patient, or - if impossible - of a relative acting as the legal representative, or - if impossible - of a physician from a non-participating department of the same hospital acting as an impartial witness .
排除标准
- •Pregnancy
- •Prior episode of transfusion-related side effect
- •Medical decision to limit therapy
- •Current participation in another trial testing a COVID-19 therapy
研究组 & 干预措施
Convalescent Plasma
2 units of plasma ( 400-500ml) from 2 different donnors duration of treatment =2 h
干预措施: Convalescent Plasma (Biological)
Standard of care
Standard of care according the last gold standards
干预措施: Standard of Care (Other)
结局指标
主要结局
Vital status
时间窗: at day 28
dead or alive
次要结局
- number of ventilator-free days at day 28(at day 28)
- number of renal replacement therapy free days at day 28(at day 28)
- lymphocyte count(Days 7, 14 and 28)
- length of stay in the acute care hospital(through study completion, 1 year)
- Katz Index of independence in Activity Day Living functional score(Day 90 and 365)
- day 90 mortality(at day 90)
- Transfusion related adverse events(till 28 days)
- number of vasopressors free-days at day 28(at day 28)
- use of ECMO before day 28(till day 28)
- changes in SOFA scores (delta SOFA) over 7, 14 and 28 days(Day 7, 14 and 28 days)
- blood C reactive protein (CRP) concentration(Days 7, 14 and 28)
- Hospital Anxiety and Depression Scale (HADS)(Day 90 and 365)
- Quality of life scale EQ-5D-5L(Day 90 and 365)
- Determine the type of concommittent inflammatory response(till 28 days)
- assessment of the SARS-CoV-2 viral load(Days 7, 14 and 28)
- location of the patient(Day 90)
- value of the SOFA score at days 7, 14 and 28(Day 1, 7, 14, 28)
- ferritin concentration(Days 7, 14 and 28)
研究者
Misset Benoit
Professor
University of Liege