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[Lancet在线发表]:克立芝(洛匹那韦-利托那韦)治疗新冠病毒感染住院患者(RECOVERY)
2020年10月28日 时讯速递, 进展交流 暂无评论

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Lopinavir–ritonavir in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

RECOVERY Collaborative Group

Lancet Published:October 05, 2020 DOI:https://doi.org/10.1016/S0140-6736(20)32013-4

Summary 摘要

Background 背景

Lopinavir–ritonavir has been proposed as a treatment for COVID-19 on the basis of in vitro activity, preclinical studies, and observational studies. Here, we report the results of a randomised trial to assess whether lopinavir–ritonavir improves outcomes in patients admitted to hospital with COVID-19.

根据体外活性、临床前研究以及观察性研究结果,克立芝(洛匹那韦-利托那韦)被建议用于治疗COVID-19。我们播啊高了一项随机临床试验结果,以评价克立芝是否能够改善COVID-19住院患者的临床预后。

Methods 方法

In this randomised, controlled, open-label, platform trial, a range of possible treatments was compared with usual care in patients admitted to hospital with COVID-19. The trial is underway at 176 hospitals in the UK. Eligible and consenting patients were randomly allocated to either usual standard of care alone or usual standard of care plus lopinavir–ritonavir (400 mg and 100 mg, respectively) by mouth for 10 days or until discharge (or one of the other RECOVERY treatment groups: hydroxychloroquine, dexamethasone, or azithromycin) using web-based simple (unstratified) randomisation with allocation concealment. Randomisation to usual care was twice that of any of the active treatment groups (eg, 2:1 in favour of usual care if the patient was eligible for only one active group, 2:1:1 if the patient was eligible for two active groups). The primary outcome was 28-day all-cause mortality. Analyses were done on an intention-to-treat basis in all randomly assigned participants. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.govNCT04381936.

在这项随机对照开放标签平台研究中,我们在COVID-19住院患者对一系列可能的治疗措施与常规治疗进行了比较。临床试验在英国的176所医院进行。采用基于网络的简单(非分层)随机及分配隐藏,符合入选标准且签署知情同意的患者接受随机分组,分别接受常规治疗,或常规治疗联合口服洛匹那韦-利托那韦(分别为400 mg和100 mg),疗程为10天或直至出院(或其他RECOVERY治疗组:羟氯喹,地塞米松或阿奇霉素)。随机分至常规治疗组的患者为其他任何治疗组患者的2倍(即如果患者仅符合一项治疗组的入选标准,常规治疗与治疗组按2:1随机;如果患者符合两个治疗组的入选标准,则按照2:1:1随机入选)。主要预后指标为28天全因病死率。对于所有接受随机分组的患者,根据意向治疗原则进行分析。试验分别在ISRCTN, 50189673, 和 ClinicalTrials.govNCT04381936注册。

Findings 结果

Between March 19, 2020, and June 29, 2020, 1616 patients were randomly allocated to receive lopinavir–ritonavir and 3424 patients to receive usual care. Overall, 374 (23%) patients allocated to lopinavir–ritonavir and 767 (22%) patients allocated to usual care died within 28 days (rate ratio 1·03, 95% CI 0·91–1·17; p=0·60). Results were consistent across all prespecified subgroups of patients. We observed no significant difference in time until discharge alive from hospital (median 11 days [IQR 5 to >28] in both groups) or the proportion of patients discharged from hospital alive within 28 days (rate ratio 0·98, 95% CI 0·91–1·05; p=0·53). Among patients not on invasive mechanical ventilation at baseline, there was no significant difference in the proportion who met the composite endpoint of invasive mechanical ventilation or death (risk ratio 1·09, 95% CI 0·99–1·20; p=0·092).

2020年3月19日至6月29日间,共1616名患者随机接受洛匹那韦-利托那韦治疗,3424名患者接受常规治疗。洛匹那韦-利托那韦组共有374名(23%)患者,常规治疗组767名(22%)患者28天内死亡(比率比 1·03, 95% CI 0·91–1·17; p=0·60)。所有预先确定的亚组分析结果一致。我们没有观察到两组患者住院时间 (两组中位数均为 11 天 [IQR 5 to >28]) 或28天内存活出院比例 (比例比 0·98, 95% CI 0·91–1·05; p=0·53)存在显著差异。对于基线时未接受有创机械通气的患者,发生复合终点(有创机械通气或死亡)的患者比例没有显著差异 (风险比 1·09, 95% CI 0·99–1·20; p=0·092)。

Interpretation 结论

In patients admitted to hospital with COVID-19, lopinavir–ritonavir was not associated with reductions in 28-day mortality, duration of hospital stay, or risk of progressing to invasive mechanical ventilation or death. These findings do not support the use of lopinavir–ritonavir for treatment of patients admitted to hospital with COVID-19.

对于COVID-19住院患者,洛匹那韦-利托那韦治疗不伴随28天病死率、住院日或进展为有创机械通气或死亡的风险降低。这些结果不支持使用洛匹那韦-利托那韦治疗COVID-19住院患者。

Funding 资助

Medical Research Council and National Institute for Health Research.

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