Treatment With Inhaled Corticosteroids in Patients Hospitalized Because of COVID19 Pneumonia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 14
- 主要终点
- Proportion of patients in both arms fulfilling the criteria for treatment failure
研究概览
简要总结
Randomized, prospective, controlled open label clinical trial aimed at investigating if the addition of inhaled corticosteroids (budesonide) reduces treatment failure (defined as a composite variable by the initiation of treatment with high flow-O2 therapy, non-invasive or invasive ventilation, systemic steroids, use of biologics (anti IL-6 or anti IL-1) and/or death) according to hospital standard of care guidance) at day 15 after initiation of therapeutic intervention.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COVID19 positive
- •hospitalized because of pneumonia (status #3 - #4 World Health Organization (WHO) scale)
- •without contraindications to receive study treatment
- •informed consent
排除标准
- •receiving corticoids (inhaled or systemic)
- •receiving anti Interleukin-1 (IL-1) or anti-IL-6 drugs
- •receiving high flow oxygen therapy
- •receiving mechanical ventilation
- •pregnancy
- •participating in another intervention trial for COVID19
研究组 & 干预措施
Intervention
patients receiving standard of care to treat their pneumonia + inhaled budesonide
干预措施: Inhaled budesonide (Drug)
结局指标
主要结局
Proportion of patients in both arms fulfilling the criteria for treatment failure
时间窗: 15 days after treatment
composite variable that includes the initiation of treatment with high flow-O2 therapy, non-invasive or invasive ventilation and/or death) at day 15 after initiation of therapeutic intervention
次要结局
- ferritin(at baseline, day 3, day 7, day 15, day 30)
- C Reactive Protein (CRP)(at baseline, day 3, day 7, day 15, day 30)
- D-dimer(at baseline, day 3, day 7, day 15, day 30)
- ICU admission(baseline, day 3, day 7, day 15, day 30)
- ICU refusal(baseline, day3, day 7, day 15, day 30)
- Occurrence of complications(baseline, day3, day 7, day 15, day 30)
- lactate dehydrogenase (LDH)(at baseline, day 3, day 7, day 15, day 30)
- leukocyte counts(at baseline, day 3, day 7, day 15, day 30)
研究者
Sara Varea
Clinical Research Manager
Fundacion Clinic per a la Recerca Biomédica