Perks of Methylprednisolone for Hospitalized COVID-19 Patients: A Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Clinical response after administration
研究概览
简要总结
In COVID-19 deep airway and alveolar destruction occurred due to inflammatory reaction resulting into severe pneumonia. In COVID-19, lung injury is not only due to viral damage to tissue, but it is also due to immune response that leads to activation of inflammatory cells and release of cytokines. In COVID-19 acute respiratory distress syndrome ARDS is produced due to mucinous or cellular fibromyxoid exudates, desquamation of pneumocytes and alveolar damage and hyaline membrane development and within 5-7 days disease become more aggressive due to pneumonia and respiratory failure. It is important to start the prompt and strengthen treatment for suppression of inflammatory response and cytokine storm. Methylprednisolone are the traditional immunosuppressive drugs. They are important and effective to delay the pneumonia progression and treating the ARDS.
Corticosteroids are broadly used as treatment for ARDS and there was an evidence for its efficacy for treating SARS and decreasing mortality of SARS in the past. However for COVID-19 corticosteroids efficacy and safety usage is still under clinical trials
详细描述
All new decision and new interventions that are made for decreasing dependency of ventilator in patients and decreasing patients mortality would have played a great role on global public health. The aim of the study is to address the efficacy of methlyprednisolone for the treatment of COVID-19 patients and its clinical outcome at a tertriary care hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •All patients of all ages, males, and females who will be diagnosed COVID-19 positive by RT-PCR with moderate illness.
- •Patients having classical radiological lesions of COVID-19 on X-ray chest or HRCT chest.
- •Respiratory rate > 22/ min and >50% of radiological involvement of lung with typical lesions.
- •FiO2 remain static or improving, along with > 30% deranged ≥ 2 biochemical markers CRP > 20 mg/l, LDH > 600 U/L, D.Dimer > 0.5mg/l or 500 ng/ml, Serum Ferritin < 500 ng/ml or mcg/l will be included in clinical trial.
排除标准
- •Heart failure,
- •Cardiac arrest
- •Decompensated liver cirrhosis,
- •Decompensated psychiatric disorder
- •Contraindication for corticosteroids
- •Leukopenia <1000/mm or neutropenia <500/mm
- •Recent or history of bone marrow or solid organ transplantation
研究组 & 干预措施
Group intervene with Methylprednisolone
Review effect of Methylprednisolone as clinical trial among hospitalized patients with COVID-19 infection.
Anyone of the following Corticosteroids dose will be given to moderate disease patients of COVID-19
- 0.5mg to 1mg/Kg methylprednisolone or equivalent dexamethasone dose (to a maximum of 20mg) given daily x 5 to 7-days or
- Methylprednisolone 1 mg/kg daily IV for 5 days followed by 40 mg daily x 3 days, followed by 10 mg daily x 2 day. *Note: in Diabetic patients' dose of methyl prednisolone should be divided in doses preferably 40mg BD.
干预措施: Methylprednisolone Injectable Product (Drug)
结局指标
主要结局
Clinical response after administration
时间窗: 10 days
Clinical improvement of COVID-19 patients by methylprednisolone.
次要结局
- Duration of hospitalization(28 days)
- Clinical response to treatment(28 days)
研究者
Dr. M.Irfan Malik
Associate Professor of Pulmonology / Focal Person COVID-19
Lahore General Hospital