A Randomized, Multicentre, Double-blind Study to Evaluate the Efficacy of High-dose Administration of Methylprednisolone in Addition to Standard Treatment, in SARS-CoV2 (COVID-19) Pneumonia Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 试验地点
- 20
- 主要终点
- Length of hospitalization
研究概览
简要总结
This double blind, randomized study is aiming to evaluate the efficacy of three doses (1gr/day) of methylpredisolone added to standard therapy in patients, with documented COVID-19 pneumonia, requiring hospitalization but not mechanical ventilation.
详细描述
Patients recently hospitalized for the treatment of documented COVID-19 pneumonia who do not require invasive ventilation will be randomized (1:1) to receive current standard treatment, which may include desamethasone and oxygen, with methylprenisolone 1gr daily iv for 3 consecutive days or standard treatment alone.
Efficacy measures will be time to recovery (discharge from hospital), invasive ventilation prevention and survival.
Patients safety will be evaluated throughout the all study period.
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)
盲法说明
Placebo controlled
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
- •age = 18 years;
- •Informed consent for participation in the study and for data processing;
- •Molecular diagnosis with Polymerase Chain Reaction (PCR) test of Sars-CoV2 infection;
- •Hospitalization in a specialist ward for Covid-19 patient care (eg., Infectious Diseases, Pulmonology or Internal Medicine);
- •Need for supplemental oxygen in any delivery mode with the exception of invasive mechanical ventilation;
- •PaO2 / FiO2 between 100 and 300 mmHg.
- •Clinical / instrumental diagnosis (high resolution chest CT scan or chest x-ray or lung ultrasound) of interstitial pneumonia for no more than three days;
- •Serum CRP greater than 5 mg / dL;
- •Interval from onset of SARS-CoV2 infection symptoms to randomization> 5 days-
排除标准
- •Invasive mechanical ventilation;
- •Presence of shock or concomitant organ failure that requires admission to the Intensive Care Unit;
- •Pregnancy or breastfeeding;
- •Severe heart or kidney failure;
- •Known hypersensitivity to methylprednisolone, to dexamethasone or to an exception;
- •Diabetes not compensated according to the doctor's judgment;
- •Other clinical conditions that contraindicate Methylprednisolone and cannot be treated or resolved according to the doctor's judgment;
- •Steroid bolus therapy in the week prior to enrollment for the study;
- •Enrollment in another clinical trial;
- •Patient already randomized in this study-
研究组 & 干预措施
B SOC plus Pb
Standard treatment (currently desamethasone 6mg/daily for 10 days) plus Placebo
干预措施: Methylprednisolone, Placebo (Drug)
A SOC plus MP
Standard treatment (currently desamethasone 6mg/daily for 10 days) plus Methylprednisolone 1gr daily iv on days 1,2,3
干预措施: Methylprednisolone, Placebo (Drug)
结局指标
主要结局
Length of hospitalization
时间窗: 30 days since randomisation
the interval between randomization and discharge from the hospital without the need for supplemental oxygen
次要结局
未报告次要终点