Our objective was to determine whether anti-interleukin (IL)-6 receptors improve outcomes of critically ill patients with coronavirus disease 2019 (COVID-19) pneumonia. We report on two cohort-embedded, investigator-initiated, multicentre, open-label, Bayesian randomised controlled clinical trials.

Patients were randomly assigned to receive either usual care (UC) or UC+tocilizumab (TCZ) 8 mg·kg^–1 (TOCI-2 trial) or UC or UC+sarilumab (SARI) 200 mg (SARI-2 trial), both intravenously on day 1 and, if clinically indicated, on day 3.

Between 31 March and 20 April 2020, 97 patients were randomised in the TOCI-2 trial, to receive UC (n=46) or UC+TCZ (n=51). At day 14, numbers of patients who did not need noninvasive ventilation (NIV) or mechanical ventilation (MV) and were alive with TCZ or UC were similar (47% versus 42%; median posterior hazard ratio (HR) 1.19, 90% credible interval (CrI) 0.71–2.04), with a posterior probability of HR >1 of 71.4%. Between 27 March and 4 April 2020, 91 patients were randomised in the SARI-2 trial, to receive UC (n=41) or UC+SARI (n=50). At day 14, numbers of patients who did not need NIV or MV and were alive with SARI or UC were similar (38% versus 33%; median posterior HR 1.05, 90% CrI 0.55–2.07), with a posterior probability of HR >1 of 54.9%. Overall, the risk of death up to day 90 was: UC+TCZ 24% versus UC 30% (HR 0.67, 95% CI 0.30–1.49) and UC+SARI 29% versus UC 39% (HR 0.74, 95% CI 0.35–1.58). Both TCZ and SARI increased serious infectious events.

In critically ill patients with COVID-19, anti-IL-6 receptors did not significantly increase the number of patients alive without any NIV or MV by day 14.

我们的目标是确定抗白细胞介素 (IL)-6 受体是否能改善 2019 年冠状病毒病 (COVID-19) 肺炎重症患者的预后。我们报告了两个队列嵌入、研究者发起、多中心、开放标签、贝叶斯随机对照临床试验。

患者被随机分配接受常规治疗 (UC) 或 UC+tocilizumab (TCZ) 8 mg·kg ^–1（TOCI-2 试验）或 UC 或 UC+sarilumab (SARI) 200 mg（SARI-2 试验），均第 1 天静脉注射，如果有临床指征，第 3 天静脉注射。

在 2020 年 3 月 31 日至 4 月 20 日期间，97 名患者在 TOCI-2 试验中被随机分配接受 UC（n=46）或 UC+TCZ（n=51）。在第 14 天，不需要无创通气 (NIV) 或机械通气 (MV) 且接受 TCZ 或 UC 的患者数量相似（47%对42%；中位后风险比 (HR) 1.19，90% 可信区间 (CrI) 0.71–2.04)，HR > 1 的后验概率为 71.4%。在 2020 年 3 月 27 日至 4 月 4 日期间，91 名患者在 SARI-2 试验中被随机分配接受 UC（n=41）或 UC+SARI（n=50）。在第 14 天，不需要 NIV 或 MV 并且在 SARI 或 UC 中存活的患者数量相似（38% vs33%；中位后验 HR 1.05, 90% CrI 0.55–2.07)，HR >1 的后验概率为 54.9%。总体而言，截至第 90 天的死亡风险为：UC+TCZ 24%与UC 30%（HR 0.67, 95% CI 0.30–1.49）和 UC+SARI 29%与UC 39%（HR 0.74, 95% CI 0.35） –1.58)。TCZ 和 SARI 都增加了严重的传染性事件。

在 COVID-19 重症患者中，到第 14 天，抗 IL-6 受体并未显着增加没有任何 NIV 或 MV 的存活患者人数。