Evaluation of the safety and efficacy of tocilizumab (AryoGen ?Pharmed Co., Iran) in patients with severe COVID-19?

Aryogen Pharmed0 个研究点目标入组 85 人开始时间: 待定最近更新: 2020年5月18日

适应症

试验速览

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•?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

•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)

发起方