Protective Role of Inhaled Steroids for Covid-19 Infection
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Time (in days) to clinical improvement within 30 days after randomization
研究概览
简要总结
We hypothesize that inhaled steroid therapy and long acting beta 2 adrenergic agonist, widely prescribed in asthma patients, may also have a local protective effect against coronavirus infection, even in patients without asthma.
The primary purpose is To compare time to clinical improvement in patients receiving standard of care associated to the combination budesonide/formoterol or standard of care only.
Time (in days) to clinical improvement is defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first within 30 days.
详细描述
D1 inclusion / randomization visit:
Patients who meet the eligibility criteria and whose infection with Covid-19 has been confirmed within 48 hours will be included in the respiratory diseases department by the pneumologist investigator.
Patients will be randomized either to the control group or to the intervention group. For interventional patients, trial treatment (SYMBICORT RAPIHALER 200/6 µ) will begin within 12 hours.
Follow-up period (D2 to D29) and end of study visit (D30):
Throughout their hospital stay, patients will be followed in accordance with the practice of the service.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Time (in days) to clinical improvement within 30 days after randomization
时间窗: within 30 days
Time (in days) to clinical improvement is defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first within 30 days. The seven-category ordinal scale consisted of the following categories: 1. Not hospitalized with resumption of normal activities 2. Not hospitalized, but unable to resume normal activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation, or both; 6. Hospitalized, requiring ECMO, invasive mechanical ventilation, or both 7. Death. These parameters will be evaluated daily during hospitalization.
次要结局
- Difference between PaO2/FiO2 ratio at randomization and at Day 7 (or at the time of stopping oxygen therapy or discharge if occurs before Day 7)(at Day 7)
- Number of days alive outside hospital within 30 days(at Day 30)
- Use of antibiotics for respiratory (proved or suspected) infection within 30 days(at Day 30)
- Mortality rate at D30(At day30)
- Time (in days) from randomization to death(up to 30 days after randomization)
- Number of days alive outside ICU within 30 days(At day30)
- Difference between CRP levels at randomization and at Day 7 (or at the time of discharge if occurs before Day 7)(at Day 7)
- Safety outcomes included events that occurred during treatment, serious adverse events, and premature discontinuation of treatment.(up to 30 days after randomization)
- Number of days alive free of invasive or non-invasive ventilation within 30 days(At day30)
- Number of days alive with oxygen therapy within 30 days(At day30)
- Maximal oxygen rate within 30 days(At day30)