Higher vs. Lower Doses of Dexamethasone in Patients With COVID-19 and Severe Hypoxia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 53
- 主要终点
- Days alive without life support at day 28
研究概览
简要总结
We aim to assess the benefits and harms of higher (12 mg) vs lower doses (6 mg) of dexamethasone on patient-centered outcomes in patients with COVID-19 and severe hypoxia.
详细描述
Background: Preliminary results from the Randomised Evaluation of COVid-19 thERapY (RECOVERY) trial have reported a reduction in 28-day mortality with low-dose dexamethasone (6 mg) once daily versus no intervention in hospitalised patients with COVID-19; an effect that may have been more pronounced in patients with increasing hypoxia. Yet, higher doses of dexamethasone may be beneficial in patients with non-COVID-19 acute respiratory distress syndrome. At present, it is unclear what dose of dexamethasone is most beneficial in patients with COVID-19 and severe hypoxia, and clinical equipoise exists.
Objective: We aim to assess the effects of higher (12 mg) vs lower doses (6 mg) of intravenous dexamethasone on the number of days alive without life-support in adult patients with COVID-19 and severe hypoxia.
Design: International, parallel-group, centrally randomised, stratified, blinded, clinical trial.
Population: Adult patients with documented COVID-19 receiving at least 10 L/min of oxygen independent of delivery system OR mechanical ventilation.
Experimental intervention: Dexamethasone 12 mg once daily for up to 10 days in addition to standard care.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •All of the following must be fulfilled
- •Aged 18 years or above AND
- •Confirmed SARS-CoV-2 (COVID-19) requiring hospitalisation AND
- •Use of one of the following:
- •Invasive mechanical ventilation OR
- •Non-invasive ventilation or continuous use of continuous positive airway pressure (CPAP) for hypoxia OR
- •Oxygen supplementation with an oxygen flow of at least 10 L/min independent of delivery system
排除标准
- •We will exclude patients who fulfil any of the following criteria:
- •Use of systemic corticosteroids for other indications than COVID-19 in doses higher than 6 mg dexamethasone equivalents
- •Use of systemic corticosteroids for COVID-19 for 5 days consecutive days or more
- •Invasive fungal infection
- •Active tuberculosis
- •Fertile woman (<60 years of age) with positive urine human gonadotropin (hCG) or plasma-hCG
- •Known hypersensitivity to dexamethasone
- •Previously randomised into the COVID STEROID 2 trial
- •Informed consent not obtainable
研究组 & 干预措施
Dexamethasone 12 mg
Intravenous bolus injection of dexamethasone 12 mg once daily in addition to standard care for up to 10 days. We will allow the use of betamethasone 12 mg at sites, where dexamethasone is not available.
干预措施: Dexamethasone (Drug)
Dexamethasone 6 mg
Intravenous bolus injection of dexamethasone 6 mg once daily in addition to standard care for up to 10 days. We will allow the use of betamethasone 6 mg at sites, where dexamethasone is not available.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Days alive without life support at day 28
时间窗: Day 28 after randomisation
Days alive without life support (i.e. invasive mechanical ventilation, circulatory support or renal replacement therapy) from randomisation to day 28
次要结局
- All-cause mortality at day 28(Day 28 after randomisation)
- Days alive without life support at day 90(Day 90 after randomisation)
- Number of participants with one or more serious adverse reactions(Day 28 after randomisation)
- Days alive and out of hospital at day 90(Day 90 after randomisation)
- Health-related quality of life at day 180(Day 180 after randomisation)
- All-cause mortality at day 90(Day 90 after randomisation)
- All-cause mortality at day 180(Day 180 after randomisation)