JPRN-jRCT2021210012已完成2 期
A phase II clinical trial with HLH-94 protocol, etoposide plus corticosteroid combination therapy, for severe illness patients with COVID-19
Tetsuji Aoyagi0 个研究点目标入组 2 人开始时间: 2021年6月14日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2
研究概览
简要总结
Although it is difficult to conclude on the efficacy of the study due to the small number of patients enrolled in the study, no efficacy of the modified HLH-94 protocol was found in the patients for either the primary or secondary endpoints. Safety was considered limited in terms of the occurrence of serious adverse reactions to the study drug.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1) Patients who have given written consent to participate in the clinical trial from themselves or a substitute.
- •(2) Inpatients aged 20 years or older at the time of obtaining consent
- •(3) Patients who have been confirmed COVID-19 by a test based on nucleic acid amplification test such as PCR or LAMP method, or by antigen testing.
- •(4) Patients who meet the following a and b for respiratory status
- •a=Confirmed COVID-19 related pneumonia by chest radiography or chest CT scan.
- •b=Rapid progression of respiratory failure (24-72 hours)
- •(5) Patients who are requiring mechanical ventilator.
- •(6) Patients with any of the following laboratory data suggesting cytokine release syndrome.
- •Ferritin >500 ng/mL and D-dimer >1 microg/mL and at least one of the following; Fever >38 deg C (within 1 day before registration), Neutrophil count/lymphocyte count ratio >10, LDH >400 U/L , CRP >15 mg/d
排除标准
- •(1) Pregnancy or breastfeeding
- •(2) History of severe hypersensitivity or adverse reactions to etoposide or prednisolone
- •(3) Absolute neutrophil count <1,000/microL
- •(4) Hemoglobin <8.0 g/dL
- •(5) Platelet count <50,000/microL
- •(6) Total bilirubin level >3.0 mg/dL
- •(7) Aspartate OR alanine aminotransferase > 5.0 x upper limit of normal
- •(8) Creatinine Clearance < 15 mL/min (calculated by Cockcroft Fault formula)
- •(9) Requiring continuous renal replacement therapy (CRRT)
- •(10) Requiring extracorporeal membrane oxygenation (ECMO)
- •(11) Other active, fatal infectious diseases
- •(12) Receiving anti-cytokine therapy (use of IL-6 inhibitors, IL-1 receptor antagonists, JAK inhibitors, etc.)
- •(13) Malignancy treated with chemotherapy
- •(14) History of HIV infection
- •(15) Receiving immunosuppressive drugs for autoimmune diseases or after transplantation
- •(16) Active hepatitis B
- •(17) Patients who are judged by the investigator or sub-investigator to be unlikely to survive for more than 48 hours
- •(18) Participating in other clinical trials or clinical research with intervention
- •(19) Patients who are judged by the investigator or sub-investigator to be inappropriate for this study due to medical conditions or safety reasons.
研究者
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