Department of Internal Medicine, School of Medicine, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Tobacco Prevention and Control Research Center (TPCRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Iran J Allergy Asthma Immunol. 2024 Feb 11;23(1):82-96. doi: 10.18502/ijaai.v23i1.14956.
The severe coronavirus disease 2019 (COVID-19) is associated with increased levels of blood interleukin (IL)-6. Therefore, it is hypothesized that modulating the levels or effects of IL-6 could diminish airway inflammation and alter the course of COVID-19. We conducted a controlled, randomized, double-blind clinical trial on hospitalized patients with severe COVID-19 in Iran. The patients were randomly distributed by block randomization to take either standard-of-care (SOC) plus 1 or 2 doses of tocilizumab 8 mg/kg or SOC alone. The endpoint was defined by clinical improvement and discharge. We enrolled 40 patients (20 patients in each group) from 10 July to 10 December 2020. After randomization, 1 patient in the SOC arm and 3 patients in the tocilizumab arm refused to participate and were eliminated from the study. The mean age of participants was 59.62±15.80 in the tocilizumab group (8 women and 9 men) and 63.52±12.83 years old in the SOC group (9 women and 10 men) groups. The number of patients who recovered did not differ significantly between the tocilizumab and SOC groups (12 [70.6%][70.6%] vs. 15 [78.9%]), respectively). Hospitalization rates were also similar between the groups (Log-rank test, p=0.615; hazard ratio, 0.83; 95% CI [0.39-1.78]). The results show that tocilizumab could not be a beneficial agent for treating severe cases of COVID-19 patients and would not significantly improve clinical outcomes.
严重的 2019 冠状病毒病(COVID-19)与血液白细胞介素(IL)-6 水平升高有关。因此,人们假设调节 IL-6 的水平或作用可能会减轻气道炎症并改变 COVID-19 的病程。我们在伊朗对患有严重 COVID-19 的住院患者进行了一项对照、随机、双盲临床试验。患者通过区组随机分配接受标准治疗(SOC)加 1 或 2 剂 8mg/kg 托珠单抗或单独 SOC。终点定义为临床改善和出院。我们于 2020 年 7 月 10 日至 12 月 10 日期间招募了 40 名患者(每组 20 名)。随机分组后,SOC 组 1 名患者和托珠单抗组 3 名患者拒绝参与并被排除在研究之外。托珠单抗组(8 名女性和 9 名男性)参与者的平均年龄为 59.62±15.80 岁,SOC 组(9 名女性和 10 名男性)参与者的平均年龄为 63.52±12.83 岁。托珠单抗组和 SOC 组的康复患者数量无显著差异(分别为 12 名[70.6%]和 15 名[78.9%])。两组的住院率也相似(对数秩检验,p=0.615;风险比,0.83;95%CI[0.39-1.78])。结果表明,托珠单抗可能不是治疗 COVID-19 重症患者的有效药物,不会显著改善临床结局。