CTRI/2020/12/029793尚未招募3 期
Efficacy and safety of tocilizumab in patients with severe COVID-19 pneumonia on steroid therapy: A prospective, randomized, double blind placebo-controlled trial
aveen Naik B0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Patients 18 years or older
- •2.Diagnosis of SARS-CoV-2 infection by RT-PCR
- •3.Pulmonary infiltrates on CXR/ CECT Chest
- •4.On COVID specific steroid therapy with IV methyl prednisolone 1 mg/kg/day or dexamethasone 6 mg per day
- •5.Severe respiratory failure with PaO2 / FiO2 less than 150 mmHg and IL-6 > 50 pg/mL with CRP > 50 mg/L
- •6.Signature of informed consent by the patient, family member or legal representative
排除标准
- •1.Less than 24 hrs of initiation of steroid therapy
- •2. Liver injury or failure (AST/ALT >= 5x Upper limit of normal)
- •3. Leukocytes < 2 Ã? 103/μl
- •4. Thrombocytes < 50 Ã? 103/μl
- •5. Severe bacterial infection (Procalcitonin > 3ng/ml)
- •6. Acute or chronic diverticulitis
- •7. Immunosuppressive therapy (e.g. mycophenolate, azathioprine, methotrexate and biologicals)
- •8. Known active or chronic tuberculosis
- •9. Known active or chronic viral hepatitis
- •10. Known allergic reactions to tocilizumab or its ingredients
研究者
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