EUCTR2020-001408-41-DE进行中（未招募）1 期
A prospective, randomized, double blinded placebo-controlled trial to evaluate the efficacy and safety of tocilizumab in patients with severe COVID-19 pneumonia - TOC-COVID
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Proof of SARS-CoV2
- •2.Severe respiratory failure:
- •a.ambient air SpO2 = 92% or
- •b.Need of = 6l O2/min or
- •c.NIV (non-invasive ventilation) or
- •d.IMV (invasive mechanical ventilation)
- •3.= 18 years
- •4.Written informed consent obtained from the patient or legal authorized representative or investigator consilium (Gießener Modell”) according to international guidelines and local laws;
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1.Non-invasive or invasive mechanical ventilation = 48 hours
- •2.Pregnancy or breast feeding
- •3.Liver injury or failure (AST/ALT = 5x ULN)
- •4.Leukocytes < 2 × 103/µl
- •5.Thrombocytes < 50 × 103/µl
- •6.Severe bacterial infection (PCT > 3ng/ml)
- •7.Acute or chronic diverticulitis
- •8.Immunosuppressive therapy (e.g. mycophenolate, azathioprine, methotrexate, biologicals, prednisolone >10mg/d; exceptions are: prednisolone = 10mg/d, sulfasalazine or hydroxychloroquine)
- •9.Known active or chronic tuberculosis
- •10.Known active or chronic viral hepatitis
- •11.Known allergic reactions to tocilizumab or its ingredients
- •12.Life expectation of less than 1 year (independent of COVID-19)
- •13.Participation in any other interventional clinical trial within the last 30 days before the start of this trial
- •14.Simultaneous participation in other interventional trials (except for participation in COVID 19 trials) which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed
- •15.Failure to use one of the following safe methods of contraception: female condoms, diaphragm or coil, each used in combination with spermicides; intra-uterine device; hormonal contraception in combination with a mechanical method of contraception;
- •Women can only take part in this study if the risk of becoming pregnant is absolutely minimized. Save contraceptive methods comprise: female condoms, diaphragm or coil, each used in combination with spermicides; intra-uterine device; hormonal contraception in combination with a mechanical method of contraception and have to be used while participating in the study
研究者
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