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临床试验/NCT04244591
NCT04244591已完成2 期

Glucocorticoid Therapy for Critically Ill Patients With Severe Acute Respiratory Infections Caused by COVID-19: a Prospective, Randomized Controlled Trial

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年1月26日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
80
试验地点
1
主要终点
Lower Murray lung injury score

研究概览

简要总结

In this multi-center, randomized, control study, the investigators will evaluate the efficacy and safety of glucocorticoid in combination with standard care for COVID-19 patents with Severe acute respiratory failure.

详细描述

COVID-19 is a novel coronavirus that was initially outbreak in Wuhan, China. Severe acute respiratory infection with COVID-19 causes severe acute respiratory failure with substantial mortality. Currently, the standard care is supportive care, and no treatment is proven to be effective for this condition.

Glucocorticoid therapy is widely used among critically ill patients with other coronavirus infection such as SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome). However, whether glucocorticoid improved the outcome of COVID-19 remains unknown. We hypothesized that glucocorticoid would improve the prognosis of patietns with COVID-19.

In this study, critically ill patients with COVID-19 were enrolled and randomized to receive ether standard care or standard care in combination with methylprednisolone therapy. The primary outcome is the difference of Murray lung injury score between two groups.

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

入选标准

  • PCR confirmed COVID-19 infection
  • Symptoms developed more than 7 days
  • PaO2/FiO2 < 200 mmHg
  • Positive pressure ventilation (non-invasive or invasive) or high flow nasal cannula (HFNC) higher than 45 L/min for less than 48 hours
  • Requiring ICU admission

排除标准

  • pregnancy;
  • patients currently taking corticosteroids (cumulative 400 mg prednisone or equivalent);
  • Severe underlying disease, i.e. end stage of malignancy disease or end stage of pulmonary disease;
  • Severe adverse events before ICU admission, i.e. cardiac arrest;
  • Underlying disease requiring corticosteroids;
  • Contraindication for corticosteroids;
  • Recruited in other clinical intervention trial

研究组 & 干预措施

standard care

Placebo Comparator

standard care

干预措施: Standard care (Other)

standard care + methylprednisolone therapy

Experimental

Methylprednisolone 40 mg q12h for 5 days

干预措施: methylprednisolone therapy (Drug)

结局指标

主要结局

Lower Murray lung injury score

时间窗: 14 days after randomization

Murray lung injury score decreased more than one point means better outcome.The Murray scoring system range from 0 to 4 according to the severity of the condition.

次要结局

  • The difference of PaO2/FiO2 between two groups(14 days after randomization)
  • Mechanical ventilation support(14 days after randomization)
  • Lower Sequential Organ Failure Assessment (SOFA) score(14 days after randomization)
  • Clearance of noval coronavirus(14 days after randomization)
  • All-cause mortality(30 days after randomization)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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