Efficacy of Injectable Methylprednisolone Sodium Succinate in the Treatment of Patients With Signs of Severe Acute Respiratory Syndrome Under the New Coronavirus (SARS-CoV2): a Phase IIb, Randomized, Double-blind, Placebo-controlled, Clinical Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 416
- 试验地点
- 1
- 主要终点
- Mortality rate at day 28
研究概览
简要总结
This is a double-blind, randomized, placebo-controlled, phase IIb clinical trial to assess the efficacy of injectable methylprednisolone sodium succinate (MP) in patients with severe acute respiratory syndrome (SARS) in COVID-19 infection. A total of 416 individuals of both sexes, aged over 18 years old, with symptoms suggestive or confirmed diagnosis of severe acute respiratory syndrome (SARS), hospitalized at the Hospital and Pronto-Socorro Delphina Rinaldi Abdel Aziz (HPSDRAA), with clinical and radiological findings suggestive of SARS-CoV2 infection, will be randomized at a 1:1 ration to receive either MP (0.5mg/kg of weight, twice daily, for 5 days) or placebo (saline solution, twice daily, for 5 days).
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
- •Suspected cases of COVID-19, from clinical and radiological data, during the pandemic;
- •Adult aged 18 years or older, at the time of inclusion (children under 18 will not be included due to the recognized lower lethality in previous published studies, and the difficulty of consent in the context of an emergency in public health);
- •SpO2 ≤ 94% in room air OR in use supplementary oxygen OR under invasive mechanical ventilation
排除标准
- •History of hypersensitivity to MPS;
- •People living with HIV and AIDS;
- •Chronic use of corticosteroids or immunosuppressive agents;
- •Pregnancy or breastfeeding;
- •Decompensated cirrhosis;
- •Chronic renal failure.
研究组 & 干预措施
Methylprednisolone
0.5mg/kg injectable methylprednisolone sodium succinate, twice daily, for 5 days.
干预措施: Methylprednisolone Sodium Succinate (Drug)
Placebo
Saline solution, twice daily, for 5 days. Injectable.
干预措施: Placebo solution (Drug)
结局指标
主要结局
Mortality rate at day 28
时间窗: on day 28, after randomization
Mortality rate on day 28, after randomization
次要结局
- Mortality rate on days 7, 14 and 28(after randomization, up to 28 days.)
- Incidence of orotracheal intubation(after randomization, up to 7 days.)
- Change in oxygenation index(after randomization, up to 7 days.)