Prolonged Low Doses of Methylprednisolone for Patients With COVID-19 Severe Acute Respiratory Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- Admission to Intensive Care Unit (ICU)
研究概览
简要总结
COVID-19 infection is overwhelming Italian healthcare. There is an urgent need for a solution to the lack of ICU beds and increasing deaths day after day.
A recent retrospective Chinese paper (JAMA Intern Med, online March 13, 2020) showed impressive positive effect of methylprednisolone (MP) on survival of SARS-CoV-2 critically ill patients. Moreover, the Italian Infectious Disease leading institution guidelines for COVID-19 clinical management included as an option for patients with "incipient worsening of respiratory functions" methylprednisolone treatment at an approximate dose of 80mg.
The main objective of this multi-centre observational trial is to analyse the association of low dose prolonged infusion of methylprednisolone (MP) for patients with severe acute respiratory syndrome with composite primary end-point (ICU referral, need for intubation, in-hospital death at day 28).
详细描述
Comparison of two groups of patients SARS-CoV-2 positive with severe acute respiratory syndrome:
- Exposed to low prolonged doses of Methylprednisolone
- Not exposed to corticosteroids (standard of care alone)
The two group will be weighted by means of a propensity score according to:
- Sex
- Age
- C-reactive protein (CRP) at baseline
- Sequential Organ Failure Assessment (SOFA) score at baseline
- PaO2/FiO2 ratio at baseline (ratio of arterial oxygen partial pressure to fractional inspired oxygen)
Anti-viral agents, chloroquine, respiratory support (any), and antibiotics (any) are allowed in each study group. Corticosteroids use, other than per-protocol Methylprednisolone in the exposed group is a reason for dropout.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SARS-CoV-2 positive
- •Age >17 years and < 80 years
- •P/F < 250 mmHg
- •Bilateral pneumonia (infiltrates/interstitial)
- •CRP >10mg/dL (or >100mg/L)
- •Alternatively to 4-5-6 criteria a diagnosis of ARDS according to the Berlin definition (Ranieri M, et al. JAMA 2012)
排除标准
- •Heart failure as predominant cause of acute respiratory failure
- •Decompensated liver cirrhosis
- •Organ transplantation
- •long-term oxygen therapy, home mechanical ventilation
- •Idiopathic pulmonary fibrosis
- •Progressive neuromuscular disorders (e.g. Duchenne, Pompe, ALS)
- •Dementia or decompensated psychiatric diseases
- •immunosuppressive treatments
- •Chronic use of corticosteroids
- •Use of Tocilizumab
- •pregnancy
研究组 & 干预措施
Exposed to Methylprednisolone
Consecutive SARS-CoV-2 positive patients with severe acute respiratory syndrome treated with methylprednisolone (MP) at low prolonged dose, fulfilling inclusion and exclusion criteria.
干预措施: Methylprednisolone (Drug)
Exposed to Methylprednisolone
Consecutive SARS-CoV-2 positive patients with severe acute respiratory syndrome treated with methylprednisolone (MP) at low prolonged dose, fulfilling inclusion and exclusion criteria.
干预措施: standard care (Other)
Non-exposed to Methylprednisolone
Concurrent patients fulfilling the same inclusion and exclusion criteria, never treated with steroids.
干预措施: standard care (Other)
结局指标
主要结局
Admission to Intensive Care Unit (ICU)
时间窗: 28 days
We reported below the number of participants admitted to ICU within 28 days.
Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation (MV), or All-cause Death by Day 28
时间窗: 28 days
We reported below the number of participants meeting at least one of three among death or ICU admission or Invasive mechanical ventilation.
In-hospital Death Within 28 Days
时间窗: 28 days
We reported below the number of participants who died within 28 days, during the hospital stay.
Endotracheal Intubation (Invasive Mechanical Ventilation)
时间窗: 28 days
We reported below the number of participants who needed endotracheal intubation during ICU admission
次要结局
- Number of Days Free From Mechanical Ventilation(28 days)
- Change in C-reactive Protein (CRP)(7 days)
研究者
marco confalonieri
Head of Pulmonology and Critical care Dept.
University of Trieste