Pulmonary, Critical Care, and Sleep Medicine, Lester and Sue Smith Chair in Lung Health, Baylor College of Medicine, 7200 Cambridge Street, Houston, TX, 77030, USA.
Providence Regional Medical Center Everett, Everett, WA, USA.
Intensive Care Med. 2021 Nov;47(11):1258-1270. doi: 10.1007/s00134-021-06507-x. Epub 2021 Oct 5.
Trials of tocilizumab in patients with severe COVID-19 pneumonia have demonstrated mixed results, and the role of tocilizumab in combination with other treatments is uncertain. Here we evaluated whether tocilizumab plus remdesivir provides greater benefit than remdesivir alone in patients with severe COVID-19 pneumonia.
This randomized, double-blind, placebo-controlled, multicenter trial included patients hospitalized with severe COVID-19 pneumonia requiring > 6 L/min supplemental oxygen. Patients were randomly assigned (2:1 ratio) to receive tocilizumab 8 mg/kg or placebo intravenously plus ≤ 10 days of remdesivir. The primary outcome was time from randomization to hospital discharge or "ready for discharge" (defined as category 1, assessed by the investigator on a 7-category ordinal scale of clinical status) to day 28. Patients were followed for 60 days.
Among 649 enrolled patients, 434 were randomly assigned to tocilizumab plus remdesivir and 215 to placebo plus remdesivir. 566 patients (88.2%) received corticosteroids during the trial to day 28. Median time from randomization to hospital discharge or "ready for discharge" was 14 (95% CI 12-15) days with tocilizumab plus remdesivir and 14 (95% CI 11-16) days with placebo plus remdesivir [log-rank P = 0.74; Cox proportional hazards ratio 0.97 (95% CI 0.78-1.19)]. Serious adverse events occurred in 128 (29.8%) tocilizumab plus remdesivir and 72 (33.8%) placebo plus remdesivir patients; 78 (18.2%) and 42 (19.7%) patients, respectively, died by day 28.
Tocilizumab plus remdesivir did not shorten time to hospital discharge or "ready for discharge" to day 28 compared with placebo plus remdesivir in patients with severe COVID-19 pneumonia.
托珠单抗治疗重症 COVID-19 肺炎患者的试验结果喜忧参半，托珠单抗联合其他治疗的作用尚不确定。在此，我们评估了托珠单抗联合瑞德西韦治疗重症 COVID-19 肺炎患者是否优于瑞德西韦单药治疗。
这是一项随机、双盲、安慰剂对照、多中心试验，纳入了因重症 COVID-19 肺炎需要补充＞6L/min 氧气而住院的患者。患者以 2:1 的比例随机分配（2:1）接受托珠单抗 8mg/kg 或安慰剂静脉注射，加用≤10 天的瑞德西韦。主要终点为从随机分组到出院或“准备出院”（定义为类别 1，由研究者在 7 级临床状态有序量表上评估）的时间至第 28 天。患者随访 60 天。
在纳入的 649 例患者中，434 例随机分配至托珠单抗联合瑞德西韦组，215 例随机分配至安慰剂联合瑞德西韦组。566 例（88.2%）患者在试验期间至第 28 天接受了皮质类固醇治疗。托珠单抗联合瑞德西韦组从随机分组到出院或“准备出院”的中位时间为 14（95%CI 12-15）天，安慰剂联合瑞德西韦组为 14（95%CI 11-16）天[对数秩检验 P=0.74；Cox 比例风险比 0.97（95%CI 0.78-1.19）]。托珠单抗联合瑞德西韦组有 128 例（29.8%）和安慰剂联合瑞德西韦组有 72 例（33.8%）患者发生严重不良事件；分别有 78 例（18.2%）和 42 例（19.7%）患者在第 28 天死亡。
与安慰剂联合瑞德西韦相比，托珠单抗联合瑞德西韦并未缩短重症 COVID-19 肺炎患者至第 28 天的出院或“准备出院”时间。
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