IRCT20150303021315N17招募中3 期
Evaluation of the safety and efficacy of tocilizumab (AryoGen ?Pharmed Co., Iran) in patients with severe COVID-19?
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 85
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
- 年龄范围
- 18 years 至 no limit（—）
- 性别
- All
入选标准
- •?Ability to comprehend and willingness to sign the informed consent form for this study by ?the patient or his/her guardian
- •Patients above 18 years old?
- •Patients with fever higher than 37.8 °C, cough, shortness of breath, or respiratory rate higher than 30 breaths/min accompanied by SpO2 = %93, who ?have a confirmed diagnosis of SARS-CoV-2 infection using PCR and/or radiography.?
- •Serum Interleukin-6 level = 3 times upper limit of normal
排除标准
- •History of hypersensitivity to Tocilizumab or any components of the formulation
- •Hepatic disease (especially active hepatic diseases and hepatic impairment)?
- •Patients with bone marrow suppression (defined as Absolute Neutrophil Count (ANC) below 2000/mm3 ?or platelet count below 100,000/mm3)?
- •Patients with a high risk of gastrointestinal perforation or with distinct history of GI disorders, e.g., active peptic ulcer and diverticulitis ?
- •Patients with active or latent tuberculosis ?
- •?Patients with history of active hepatitis B, hepatitis C, HIV, or any known immunodeficiency
- •Pregnant or lactating patients
- •Patients with any other active infection in addition to COVID-19
- •Patients with any other disease or disorder, which, in the opinion of the investigator will put the subject at risk, ?if they are enrolled
- •Renal impairment (GFR of below 30ml/min/1.73m2)
研究者
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