Dexamethasone and Oxygen Support Strategies in ICU Patients With Covid-19 pneumonia_COVIDICUS
试验速览
- 阶段
- 不适用
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- The time-to-death from all causes
研究概览
简要总结
The main manifestation of COVID-19 is acute hypoxemic respiratory failure (AHRF). In patients with AHRF, the need for invasive mechanical ventilation is associated with high mortality.
Two hypotheses will be tested in this study. The first hypothesis is the benefit of corticosteroid therapy on severe COVID-19 infection admitted in ICU in terms of survival.
The second hypothesis is that, in the subset of patients free of mechanical ventilation at admission, either Continuous Positive Airway Pressure (CPAP) or High-Flow Nasal Oxygen (HFNO) allows to reduce intubation rate safely during COVID-19 related acute hypoxemic respiratory failure.
详细描述
The main manifestation of COVID-19 is acute hypoxemic respiratory failure (AHRF). In patients with AHRF, the need for invasive mechanical ventilation is associated with high mortality.
Two hypotheses will be tested in this study. The first hypothesis is the benefit of corticosteroid therapy on severe COVID-19 infection admitted in ICU in terms of survival.
The second hypothesis is that, in the subset of patients free of mechanical ventilation at admission, either Continuous Positive Airway Pressure (CPAP) or High-Flow Nasal Oxygen (HFNO) allows to reduce intubation rate safely during COVID-19 related acute hypoxemic respiratory failure.
The main objective is to assess the impact of dexamethasone on overall mortality at day-60 after randomization in patients admitted in ICU for severe COVID-19 infection.
In non mechanical ventilation (MV) patients, the additional objective is to assess whether oxygen support based on either HFNO or CPAP modality in COVID-19 related AHRF reduces the need for mechanical ventilation at day-28.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The masking label is available only for the treatment assignation
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
- •Admitted to ICU within 48 hours
- •Confirmed or highly suspected COVID-19 infection
- •Acute hypoxemic respiratory failure (PaO2 <70 mmHg or SpO2<90% on room air or tachypnea>30/min or labored breathing or respiratory distress; need for oxygen flow >=6L/min)
- •Any treatment intended to treat the SARS-CoV-2 infection in the absence of contraindications (either as a compassionate use or in the context of a clinical trial, i.e remdesivir, lopinavir/ritonavir, favipiravir, hydroxychloroquine and any other new drug with potential activity).
- •Non-inclusion Criteria:
- •Moribund status
- •Pregnancy or breastfeeding
- •Long term corticotherapy at a dose of 0.5mg/kg/j or higher
- •Active and untreated bacterial, fungal or parasitic infection
- •Not Written informed consent from the patient or a legal representative if appropriate . If absence a legal representative the patient may be included in emergency procedure
- •hypersensitivity to dexamethasone or to any of the excipients
- •Not Affiliation to the French social security
排除标准
- 未提供
研究组 & 干预措施
Standard oxygen 1
Standard oxygen and placebo of Dexamethasone
干预措施: placebo (Drug)
Standard oxygen 1
Standard oxygen and placebo of Dexamethasone
干预措施: conventional oxygen (Procedure)
Standard oxygen 2
Standard oxygen and Dexamethasone
干预措施: Dexamethasone injection (Drug)
Standard oxygen 2
Standard oxygen and Dexamethasone
干预措施: conventional oxygen (Procedure)
CPAP 1
CPAP and placebo of Dexamethasone
干预措施: placebo (Drug)
CPAP 1
CPAP and placebo of Dexamethasone
干预措施: CPAP (Procedure)
CPAP 2
CPAP and Dexamethasone
干预措施: Dexamethasone injection (Drug)
CPAP 2
CPAP and Dexamethasone
干预措施: CPAP (Procedure)
HFNO 1
HFNO and placebo of Dexamethasone
干预措施: placebo (Drug)
HFNO 1
HFNO and placebo of Dexamethasone
干预措施: HFNO (Procedure)
HFNO 2
HFNO and Dexamethasone
干预措施: Dexamethasone injection (Drug)
HFNO 2
HFNO and Dexamethasone
干预措施: HFNO (Procedure)
mechanically ventilated 1
placebo
干预措施: placebo (Drug)
mechanically ventilated 1
placebo
干预措施: mechanical ventilation (Procedure)
mechanically ventilated 2
Dexamethasone
干预措施: Dexamethasone injection (Drug)
mechanically ventilated 2
Dexamethasone
干预措施: mechanical ventilation (Procedure)
结局指标
主要结局
The time-to-death from all causes
时间窗: day-60
The time-to-death from all causes within the first 60 days after randomization.
The time to need for mechanical ventilation (MV)
时间窗: day-28.
the time to need for mechanical ventilation (MV), as defined by any of the 3 criteria for intubation within the first 28 days after randomization.
次要结局
- Lengths of hospital-stay(day-60)
- The viral load in the respiratory tract(day-10)
- Number of patient with at least one episode of healthcare-associated infections(day-28)
- Number of days alive without mechanical ventilation(day-28)
- Measure of SOFA score(day-1 to day 3, day 7, day 10, day 21, day 28)
- Number of days alive without renal replacement therapy(day-28)
- Lengths of ICU-stay(day-60)
- Number of patients with severe hypoxemia,(day 60)
- Proportion of patients with cardiac arrest within 1 hour after intubation(day 60)
- Overall survival(day 60)