An Open-label, Randomized, Cross-over Interventional Study to Evaluate the Efficacy and Safety of Tocilizumab Versus Corticosteroids in Hospitalised COVID-19 Patients With High Risk of Progression
试验速览
- 阶段
- 3 期
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- The proportion of patients requiring mechanical ventilation
研究概览
简要总结
This study aims to compare the efficacy and safety of Methylprednisolone versus Tocilizumab in improving clinical outcomes and reducing the need for ventilator support in COVID-19 patients with moderate COVID-19 disease at risk for complications of cytokine storm. Approximately 310 participants hospitalized with COVID-19 in UMMC, Hospital Sungai Buloh, Hospital Kuala Lumpur and Hospital Tuanku Jaafar will be enrolled into this study.
Eligible participants will be selected based on a set of clinical, laboratory and radiological parameters indicative of early stages of CRS and lung function decline prior to being randomized at a ratio of 1:1 to receive either Tocilizumab or Methylprednisolone. Participants will be monitored daily for clinical and laboratory parameters, and at 48 hours, switched to the alternate study arm should they manifest signs and symptoms indicative of decompensation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 否
入选标准
- •Hospitalised symptomatic COVID-19 patients 2( Presence of clinical and radiological signs of progressive disease, AND laboratory evidence indicative of risk for cytokine storm complications.
- •All patients participating in this clinical trial must meet the following inclusion criteria:
- •Hospitalised symptomatic COVID-19 patients
- •Presence of clinical and radiological signs of progressive disease, AND laboratory evidence indicative of risk for cytokine storm complications:
- •Dyspnoea OR RR>20 breaths/min AND O2 sat <93% on RA OR increasing need for O2 supplementation to maintain O2 sat >95% on RA
- •Radiological:
- •CXR or CT indicative of pneumonia OR worsening findings over time
- •Laboratory:
- •CRP levels >60 OR an increase of CRP >20 over 12 hours WITH an increasing ferritin level OR declining lymphocyte counts
- •Age > 18 years and able to give consent
排除标准
- •Patients will be excluded if any of the following conditions apply:
- •Known sensitivity/allergy to TCZ or other monoclonal antibodies
- •AST/ALT>5 times UNL, platelet counts <50,000 or neutrophil counts <500
- •Receipt of mechanical ventilation
- •Has received other immunomodulatory drugs (including TCZ) in the past for the treatment of other conditions
- •Individuals, in the opinion of the investigator, where progression to death is imminent and inevitable in the next 24 hours irrespective of treatment provision or who have signed a DNR.
- •Participating in other clinical trials (subject to approval)
- •Any serious medical condition or abnormal clinical laboratory tests which in the judgement of the investigator may compromise patient safety should he/she participate in the study.
研究组 & 干预措施
Tocilizumab
Tocilizumab is given at 8 mg/kg (body weight) once and administered as an intravenous infusion within no less than 60 minutes.
干预措施: Tocilizumab (Drug)
Methylprednisolone
Reconstituted methylprednisolone is infused over 30 minutes and administered at a dose of 120mg/day for 3 days
干预措施: Methylprednisolone (Drug)
结局指标
主要结局
The proportion of patients requiring mechanical ventilation
时间窗: Through study completion, and average of 6 months
Mean days of ventilation
时间窗: Through study completion, and average of 6 months
次要结局
- Duration of hospital and ICU stay(Through study completion, and average of 6 months)
- Overall 28-day survival(28 day from baseline)
- Change in symptom severity assessed by the World Health Organization (WHO) Coronavirus Disease 2019 (COVID19) ordinal scale measured daily up to 7 days from baseline(7 days from baseline)
- The proportion of patients requiring ICU admission(Through study completion, and average of 6 months)