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临床试验/NCT04395105
NCT04395105终止3 期

High Versus Low Dose Dexamethasone for the Treatment of COVID-19 Related ARDS: a Multicenter and Randomized Open-label Clinical Trial

Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年5月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
终止
发起方
入组人数
100
试验地点
4
主要终点
Time to successful discontinuation from mechanical ventilation

研究概览

简要总结

There is compelling data indicating that there is an excessive inflammatory response in some patients with COVID-19 leading them to develop ARDS that can be severe with a very poor prognosis. Many of these patients require very long mechanical ventilation times to survive, which have led to the collapse of the health system in some regions of the world. The current evidence for the treatment of these severe forms is inconsistent and most scientific societies and governmental or international organizations recommend evaluating treatments with randomized clinical trials. Corticosteroids, being non-specific anti-inflammatory drugs, could shorten the duration of respiratory failure and improve the prognosis. Due to the lack of solid data available regarding this serious disease, our objective is to randomly evaluate the efficacy and safety of the use of dexamethasone, a parenteral corticosteroid approved in Argentina, in patients with ARDS with confirmed respiratory infection due to SARS-CoV-2 (COVID-19).

After RECOVERY trial prepublication, low dose (6 mg QD for 10 days) dexamethasone was recommended as the usual care treatment for severe COVID-19. At this time only 3 patients had been included in the trial. Thus, we updated our recommendations for centers and decided to compare two different doses of this glucocorticoid for the treatment of ADRS due to 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

入选标准

  • ARDS according to Berlin's definition
  • PCR confirmed COVID-19
  • Length of mechanical ventilation less or equal to 72 hours

排除标准

  • Pregnancy or breast-feeding women
  • Terminal illness with very poor prognosis according to the investigator judgement
  • Therapeutic limitation
  • Known immunocompromised condition
  • Chronic use of systemic corticosteroids
  • Participation in another randomized crinical trial
  • More than 5 days of treatment of low dose dexamethasone for COVID-19
  • Abscence of informed consent
  • Active participation in other randomized clinical trial

研究组 & 干预措施

High dose Dexamethasone

Experimental

Intravenous Dexamethasone 16 mg qd from day 1 to 5 followed by 8 mg qd from day 6 to 10

干预措施: High-Dose Dexamethasone (Drug)

结局指标

主要结局

Time to successful discontinuation from mechanical ventilation

时间窗: 28 days after randomization

Time to event (successful discontinuation from mechanical ventilation)

Ventilator-free days at 28 days

时间窗: 28 days after randomization

Days without ventilator support in the first 28 days following randomization

次要结局

  • SOFA variation(10 days after randomization)
  • Use of prone position(10 days after randomization)
  • 28-days mortality(28 days after randomization)
  • Muscle weakness(28 days after randomization)
  • Peak daily blood glucose(10 days after randomization)
  • Delirium(28 days after randomization)
  • Rate of nosocomial infections(28 days after randomization)
  • 90-day mortality(90 days after randomization)

研究者

发起方
Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pablo Oscar Rodriguez

Pulmonary and Critical Care Coordinator

Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

研究点 (4)

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