COVID-19, a disease caused by the novel coronavirus SARS-CoV-2, has produced a serious emergency for global public health, placing enormous stress on national health systems in many countries. Several studies suggest that cytokine storms (interleukins) may play an important role in severe cases of COVID-19. Neutralizing key inflammatory factors in cytokine release syndrome (CRS) could therefore be of great value in reducing the mortality rate. Tocilizumab (TCZ) in its intravenous (IV) form of administration -RoActemra® 20 mg/mL (Roche)-is indicated for treatment of severe CRS patients. Preliminary investigations have concluded that inhibition of IL-6 with TCZ appears to be efficacious and safe, with several ongoing clinical trials. This has led to a huge increase in demand for IV TCZ for treating severe COVID-19 patients in hospitals, which has resulted in drug shortages. Here, we present a comparability study assessing the main critical physicochemical attributes of TCZ solutions used for infusion, at 6 mg/mL and 4 mg/mL, prepared from RoActemra® 20 mg/mL (IV form) and from RoActemra® 162 mg (0.9 mL solution pre-filled syringe, subcutaneous(SC) form), to evaluate the use of the latter for preparing clinical solutions required for IV administration, so that in a situation of shortage of the IV medicine, the SC form could be used to prepare the solutions for IV delivery of TCZ. It is important to remember that during the current pandemic all the medicines are used off-label, since none of them has yet been approved for the treatment of COVID-19.

COVID-19 是一种由新型冠状病毒 SARS-CoV-2 引起的疾病，给全球公共卫生带来了严重的紧急情况，给许多国家的国家卫生系统带来了巨大压力。多项研究表明，细胞因子风暴（白细胞介素）可能在 COVID-19 重症病例中发挥重要作用。因此，中和细胞因子释放综合征（CRS）中的关键炎症因子对于降低死亡率具有重要价值。托珠单抗 (TCZ) 的静脉注射 (IV) 形式 -RoActemra® 20 mg/mL（罗氏） - 适用于治疗严重的 CRS 患者。初步研究得出的结论是，用 TCZ 抑制 IL-6 似乎是有效且安全的，多项临床试验正在进行中。这导致医院治疗重症 COVID-19 患者的 IV TCZ 需求大幅增加，从而导致药物短缺。在这里，我们提出了一项可比性研究，评估用于输注的 TCZ 溶液的主要关键理化属性，浓度为 6 mg/mL 和 4 mg/mL，由 RoActemra® 20 mg/mL（IV 型）和 RoActemra® 162 mg（IV 型）制备。 0.9 mL溶液预充注射器，皮下（SC）形式），评价后者用于制备静脉给药所需临床溶液的用途，以便在静脉药物短缺的情况下，可以使用SC形式准备 TCZ 静脉注射的解决方案。重要的是要记住，在当前的大流行期间，所有药物都是超说明书使用的，因为尚未批准用于治疗 COVID-19。