Efficacy of Low or High Dose of Dexamethasone in Patients With Respiratory Failure by COVID-19
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Percentage of patients with treatment failure at day 11
研究概览
简要总结
After RECOVERY trial publication, low dose (6 mg dexamethasone for 10 days) was recommended as the usual care treatment in hospitalized patients with respiratory failure by COVID-19 needing oxygen therapy. RECOVERY trial showed how the use of dexamethasone 6 mg / day for ten days compared to standard treatment without the use of corticosteroids in hospitalized patients reduced mortality at 28 days (22.9% with dexamethasone vs 25.7% without dexamethasone). In the dexamethasone group, the incidence of mortality was lower than standard treatment in patients with hypoxia and the need for mechanical ventilation (29.3% with dexamethasone vs 41.4% without dexamethasone), in patients admitted to the hospital ward with a need for oxygen therapy (23.3% with dexamethasone vs 26.2% without dexamethasone), but they did not find differences between those admitted patients who did not need oxygen therapy. There are two other studies (DEXA-COVID-19 and CoDEX) where they observed benefits of the use of dexamethasone 20 mg / day 5 days, and 10 mg / day 5 days (total 10 days) in patients admitted for respiratory distress syndrome (ARDS) and COVID-19. At present, it is unclear what dose of dexamethasone is most beneficial in patients with COVID-19 and respiratory failure.
详细描述
Objective
The investigators aim to assess the efficacy of high dose of dexamethasone (20 mg / day 5 days, and 10 mg/day 5 days) versus low dose of dexamethasone (6 mg/day 10 days) in patients with respiratory failure by COVID-19.
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 or older.
- •Hospitalized COVID-19 patients admitted to the Hospital.
- •Patients requiring supplemental oxygen. Level 4 using the World Health Organization 7-point Ordinal Scale for clinical improvement
- •Patients requiring corticosteroids (dexamethasone) according to Hospital protocol.
排除标准
- •Pregnancy or active lactation.
- •Patient is expected to die in the next 48 hours.
- •Known history of dexamethasone allergy or known contraindication to the use of corticosteroids.
- •Daily use of corticosteroids in the past 15 days.
- •Indication for corticosteroids use for other clinical conditions (e.g. refractory septic shock).
- •Consent refusal for participating in the trial.
- •Different level of 4 in Level 4 using the World Health Organization 7-point Ordinal Scale for clinical improvement.
研究组 & 干预措施
Low dose group
Dexamethasone 6mg/day for 10 days
干预措施: Dexamethasone low dose (Drug)
High dose group
Dexamethasone 20mg/day for 5 days + Dexamethasone 10mg/day for 5 days (Total 10 days)
干预措施: Dexamethasone high dose (Drug)
结局指标
主要结局
Percentage of patients with treatment failure at day 11
时间窗: Day 11 after randomization
defined as death, need of ICU and extracorporeal membrane oxygenation, need of non-invasive ventilation or nasal high-flow oxygen therapy, or worsening of the condition clinic of the patient during treatment (two of these: need to increase Fraction of inspired oxygen inspired\>20%, need for fraction inspired oxygenation\>50%, increase in respiratory rate\>25, increase in inflammatory markers).
次要结局
- 90-days mortality(90 days after randomization)
- 28-days mortality(28 days after randomization)
- Percentage of patients without the need for oxygen support at day 11.(Day 11 after randomization)
- Infectious complications during hospital admission(90 days after randomization)
- Adverse drug reactions(11 days after randomization)
- Percentage of patients needing Intensive Care Unit admission(28 days after randomization)
- Length of stay in the hospital(90 days after randomization)
- Clinical status of patients using the World Health Organization 7-point Ordinal Scale for clinical improvement during 10 days of treatment(10 days after randomization)
- Percentage of patients needing invasive mechanical ventilation or extracorporeal membrane oxygenation(28 days after randomization)
- Percentage of patients needing non-invasive ventilation or nasal high-flow oxygen therapy(28 days after randomization)
研究者
Manuel Taboada Muñiz
Associate Proffesor
Hospital Clinico Universitario de Santiago