Promising effects of tocilizumab in COVID-19: A non-controlled, prospective clinical trial.,International Immunopharmacology

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Promising effects of tocilizumab in COVID-19: A non-controlled, prospective clinical trial.
International Immunopharmacology ( IF 4.8 ) Pub Date : 2020-08-04 , DOI: 10.1016/j.intimp.2020.106869
Farzaneh Dastan ₁ , Ali Saffaei ₂ , Sara Haseli ₃ , Majid Marjani ₄ , Afshin Moniri ₅ , Zahra Abtahian ₄ , Atefeh Abedini ₃ , Arda Kiani ₆ , Sharareh Seifi ₃ , Hamidreza Jammati ₃ , Seyed Mohammad Reza Hashemian ₃ , Mihan Pourabdollah Toutkaboni ₇ , Alireza Eslaminejad ₃ , Jalal Heshmatnia ₃ , Mohsen Sadeghi ₃ , Seyed Alireza Nadji ₅ , Alireza Dastan ₈ , Parvaneh Baghaei ₄ , Mohammad Varahram ₃ , Sahar Yousefian ₁ , Jamshid Salamzadeh ₉ , Payam Tabarsi ₄

Affiliation

Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Chronic Respiratory Diseases Research Center (CRDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Student Research Committee, Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Chronic Respiratory Diseases Research Center (CRDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Clinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Virology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Tracheal Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Lung Transplant Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Ernest and Julio Gallo Management Program, School of Engineering, University of California, Merced, CA, United States.
Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Background

The clinical presentation of SARS-CoV-2 infection ranges from mild symptoms to severe complications, including acute respiratory distress syndrome. In this syndrome, inflammatory cytokines are released after activation of the inflammatory cascade, with the predominant role of interleukin (IL)-6. The aim of this study was to evaluate the effects of tocilizumab, as an IL-6 antagonist, in patients with severe or critical SARS-CoV-2 infection.

Methods

In this prospective clinical trial, 76 patients with severe or critical SARS-CoV-2 infection were evaluated for eligibility, and ultimately, 42 patients were included. Tocilizumab was administered at a dose of 400 mg as a single dose via intravenous infusion. Primary outcomes included changes in oxygenation support, need for invasive mechanical ventilation, and death. Secondary outcomes included radiological changes in the lungs, IL-6 plasma levels, C-reactive protein levels, and adverse drug reactions. The data were analyzed using SPSS software.

Results

Of the 42 included patients, 20 (48%) patients presented the severe infection stage and 22 (52%) were in the critical stage. The median age of patients was 56 years, and the median IL-6 level was 28.55 pg/mL. After tocilizumab administration, only 6 patients (14%) required invasive ventilation. Additionally, 35 patients (83.33%) showed clinical improvement. By day 28, a total of 7 patients died (6 patients in the critical stage and 1 patient in the severe stage). Neurological adverse effects were observed in 3 patients.

Conclusions

Based on the current results, tocilizumab may be a promising agent for patients with severe or critical SARS-CoV-2 infection, if promptly initiated during the severe stage.

中文翻译：

托珠单抗在COVID-19中的潜在作用：一项非对照的前瞻性临床试验。

背景

SARS-CoV-2感染的临床表现范围从轻度症状到严重并发症，包括急性呼吸窘迫综合征。在该综合征中，炎性级联反应激活后释放炎性细胞因子，其中白介素（IL）-6的主要作用。这项研究的目的是评估作为IL-6拮抗剂的tocilizumab在严重或严重SARS-CoV-2感染患者中的作用。

方法

在这项前瞻性临床试验中，对76例严重或严重SARS-CoV-2感染患者进行了资格评估，最终纳入了42例患者。经由静脉输注以单剂量400 mg的剂量服用Tocilizumab。主要结果包括充氧支持的改变，有创机械通气的需要和死亡。次要结果包括肺部的放射学变化，IL-6血浆水平，C反应蛋白水平和药物不良反应。使用SPSS软件分析数据。

结果

在42名患者中，有20名（48％）处于严重感染阶段，而22名（52％）处于危重阶段。患者的中位年龄为56岁，中位IL-6水平为28.55 pg / mL。给予托珠单抗后，仅6例（14％）患者需要有创通气。此外，有35例患者（83.33％）表现出临床改善。到第28天，共有7例患者死亡（危重阶段6例，重症阶段1例）。在3名患者中观察到神经学不良反应。