Dexamethasone and Oxygen Support Strategies in ICU Patients With Covid-19 Pneumonia (COVIDICUS)
Dexamethasone and Oxygen Support Strategies in ICU Patients With Covid-19 pneumonia_COVIDICUS
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.
研究概览
地位
详细说明
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.
An ancillary study CACAO (COVIDICUS air contamination) will be performed in 4 centers aiming at assessing the environmental contamination by SARS-CoV-2 according to the oxygen support modality. Additional funding will be searched for these analyses (submitted for ANR call).
A metanalysis on individual data will be performed using patients enrolled in the 3 PHRC flash exploring the activity of corticosteroids.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
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Paris、法国、75018
- Hôpital Bichat - APHP
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：Standard oxygen 1
Standard oxygen and placebo of Dexamethasone
|
Box of 10 NaCl 0,9% , solution for injection in ampoule of 5mL.
Each allocated box contains complete treatment from D1 to D10 for one patient.
The oxygen flow will be adjusted to maintain an oxygen saturation level of 92% or more, as measured by means of pulse oximetry (SpO2)
|
|
实验性的：Standard oxygen 2
Standard oxygen and Dexamethasone
|
The oxygen flow will be adjusted to maintain an oxygen saturation level of 92% or more, as measured by means of pulse oximetry (SpO2)
Box of 10 DEXAMETHASONE 20 mg / 5 ml, solution for injection in ampoule of 5mL.
Each allocated box contains complete treatment from D1 to D10 for one patient.
其他名称：
|
|
实验性的：CPAP 1
CPAP and placebo of Dexamethasone
|
Box of 10 NaCl 0,9% , solution for injection in ampoule of 5mL.
Each allocated box contains complete treatment from D1 to D10 for one patient.
Patients assigned to the CPAP plus oxygen group will receive periods of CPAP in addition to the standard treatment.The oxygen flow will be adjusted to maintain an oxygen saturation level of 92% or more, as measured by means of pulse oximetry (SpO2)
|
|
实验性的：CPAP 2
CPAP and Dexamethasone
|
Box of 10 DEXAMETHASONE 20 mg / 5 ml, solution for injection in ampoule of 5mL.
Each allocated box contains complete treatment from D1 to D10 for one patient.
其他名称：
Patients assigned to the CPAP plus oxygen group will receive periods of CPAP in addition to the standard treatment.The oxygen flow will be adjusted to maintain an oxygen saturation level of 92% or more, as measured by means of pulse oximetry (SpO2)
|
|
实验性的：HFNO 1
HFNO and placebo of Dexamethasone
|
Box of 10 NaCl 0,9% , solution for injection in ampoule of 5mL.
Each allocated box contains complete treatment from D1 to D10 for one patient.
TIn the high-flow-nasal cannula group, oxygen will be delivered through a heated humidifier (Airvo-2, Fisher and Paykel Healthcare) and applied continuously through large-bore binasal prongs, with a gas flow rate of 30 liters per minute and adjusted based on the clinical response.
FiO2 will be adjusted for the target SpO2
|
|
实验性的：HFNO 2
HFNO and Dexamethasone
|
Box of 10 DEXAMETHASONE 20 mg / 5 ml, solution for injection in ampoule of 5mL.
Each allocated box contains complete treatment from D1 to D10 for one patient.
其他名称：
TIn the high-flow-nasal cannula group, oxygen will be delivered through a heated humidifier (Airvo-2, Fisher and Paykel Healthcare) and applied continuously through large-bore binasal prongs, with a gas flow rate of 30 liters per minute and adjusted based on the clinical response.
FiO2 will be adjusted for the target SpO2
|
|
安慰剂比较：mechanically ventilated 1
placebo
|
Box of 10 NaCl 0,9% , solution for injection in ampoule of 5mL.
Each allocated box contains complete treatment from D1 to D10 for one patient.
The oxygen flow will be adjusted to maintain an oxygen saturation level of 92% or more, as measured by means of pulse oximetry (SpO2)
|
|
实验性的：mechanically ventilated 2
Dexamethasone
|
Box of 10 DEXAMETHASONE 20 mg / 5 ml, solution for injection in ampoule of 5mL.
Each allocated box contains complete treatment from D1 to D10 for one patient.
其他名称：
The oxygen flow will be adjusted to maintain an oxygen saturation level of 92% or more, as measured by means of pulse oximetry (SpO2)
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The time-to-death from all causes
大体时间：day-60
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The time-to-death from all causes within the first 60 days after randomization.
|
day-60
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The time to need for mechanical ventilation (MV)
大体时间：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.
|
day-28.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The viral load in the respiratory tract
大体时间：day-10
|
The cycle threshold for SARS-CoV-2 PCR at baseline, day 7+/-1 and day 10 +/- in samples of the same origin (preferably subglottic i.e. bronchoalveolar lavage or tracheal aspiration, otherwise nasopharyngeal swab)
|
day-10
|
|
Number of patient with at least one episode of healthcare-associated infections
大体时间：day-28
|
Proportion of patients with at least one episode of any healthcare-associated infection between randomization and D28
|
day-28
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|
Number of days alive without mechanical ventilation
大体时间：day-28
|
To compare the exposition to mechanical ventilation
|
day-28
|
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Measure of SOFA score
大体时间：day-1 to day 3, day 7, day 10, day 21, day 28
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Changes in SOFA (Sepsis-related Organ Failure Assessment) score.
(min = 0 for normal status max = 24 for worse status)
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day-1 to day 3, day 7, day 10, day 21, day 28
|
|
Number of days alive without renal replacement therapy
大体时间：day-28
|
to compare the exposition to renal replacement therapy
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day-28
|
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Lengths of ICU-stay
大体时间：day-60
|
To compare the lengths of ICU
|
day-60
|
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Lengths of hospital-stay
大体时间：day-60
|
To compare the lengths of hospital-stay
|
day-60
|
|
Number of patients with severe hypoxemia,
大体时间：day 60
|
Proportion of patients with severe hypoxemia, which is defined as an oxygen saturation of less than 80% during the same interval during the interval between induction and 2 minutes after tracheal intubation
|
day 60
|
|
Proportion of patients with cardiac arrest within 1 hour after intubation
大体时间：day 60
|
Proportion of patients with cardiac arrest within 1 hour after intubation
|
day 60
|
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Overall survival
大体时间：day 60
|
To compare Overall survival after randomization
|
day 60
|
合作者和调查者
调查人员
- 首席研究员：Jean François TIMSIT, Pr、Assistance Publique - Hôpitaux de Paris
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- APHP200388
- 2020-001457-43 (EudraCT编号)
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