Background

Aspirin has been proposed as a treatment for COVID-19 on the basis of its anti-thrombotic properties. We aimed to evaluate the efficacy and safety of aspirin in patients admitted to hospital with COVID-19.

Methods

In this randomised, controlled, open-label, platform trial, several possible treatments were compared with usual care in patients hospitalised with COVID-19. The trial took place at 177 hospitals in the UK, two hospitals in Indonesia, and two hospitals in Nepal. Eligible and consenting adults were randomly allocated in a 1:1 ratio to either usual standard of care plus 150 mg aspirin once per day until discharge or usual standard of care alone using web-based simple (unstratified) randomisation with allocation concealment. The primary outcome was 28 day mortality. All analyses were done by intention to treat. The trial is registered with ISRCTN (50189673) and ClinicalTrials.gov (NCT04381936).

Findings

Between Nov 1, 2020, and March 21, 2021, 14 892 (66%) of 22 560 patients enrolled into the RECOVERY trial were eligible to be randomly allocated to aspirin. 7351 patients were randomly allocated (1:1) to receive aspirin and 7541 patients to receive usual care alone. Overall, 1222 (17%) of 7351 patients allocated to aspirin and 1299 (17%) of 7541 patients allocated to usual care died within 28 days (rate ratio 0·96, 95% CI 0·89–1·04; p=0·35). Consistent results were seen in all prespecified subgroups of patients. Patients allocated to aspirin had a slightly shorter duration of hospitalisation (median 8 days, IQR 5 to >28, vs 9 days, IQR 5 to >28) and a higher proportion were discharged from hospital alive within 28 days (75% vs 74%; rate ratio 1·06, 95% CI 1·02–1·10; p=0·0062). Among patients not on invasive mechanical ventilation at baseline, there was no significant difference in the proportion meeting the composite endpoint of invasive mechanical ventilation or death (21% vs 22%; risk ratio 0·96, 95% CI 0·90–1·03; p=0·23). Aspirin use was associated with a reduction in thrombotic events (4·6% vs 5·3%; absolute reduction 0·6%, SE 0·4%) and an increase in major bleeding events (1·6% vs 1·0%; absolute increase 0·6%, SE 0·2%).

Interpretation

In patients hospitalised with COVID-19, aspirin was not associated with reductions in 28 day mortality or in the risk of progressing to invasive mechanical ventilation or death, but was associated with a small increase in the rate of being discharged alive within 28 days.

Funding

UK Research and Innovation (Medical Research Council), National Institute of Health Research, and the Wellcome Trust through the COVID-19 Therapeutics Accelerator.

中文翻译：

---

阿司匹林用于治疗 COVID-19 入院患者（恢复）：一项随机、对照、开放标签平台试验

背景

阿司匹林因其抗血栓特性而被提议作为 COVID-19 的治疗方法。我们的目的是评估阿司匹林对住院的 COVID-19 患者的疗效和安全性。

方法

在这项随机、对照、开放标签平台试验中，对住院的 COVID-19 患者的几种可能的治疗方法与常规治疗进行了比较。该试验在英国 177 家医院、印度尼西亚两家医院和尼泊尔两家医院进行。符合条件并同意的成年人按照 1:1 的比例随机分配到常规标准护理加每天一次 150 毫克阿司匹林直至出院，或使用基于网络的简单（非分层）随机分配和分配隐藏仅常规标准护理。主要结局是 28 天死亡率。所有分析均按意向治疗进行。该试验已在 ISRCTN (50189673) 和 ClinicalTrials.gov (NCT04381​​936) 注册。

发现

2020年11月1日至2021年3月21日期间，参加RECOVERY试验的22560名患者中有14892名患者（66%）有资格被随机分配到阿司匹林治疗。7351 名患者被随机分配（1:1）接受阿司匹林治疗，7541 名患者接受单独常规护理。总体而言，接受阿司匹林治疗的 7351 名患者中有 1222 名患者 (17%) 以及接受常规护理的 7541 名患者中有 1299 名患者 (17%) 在 28 天内死亡（比率为 0·96，95% CI 0·89–1·04；p= 0·35）。在所有预先指定的患者亚组中都观察到了一致的结果。分配到阿司匹林的患者住院时间稍短（中位 8 天，IQR 5 至 >28，对比9 天，IQR 5 至 >28），并且在 28 天内存活出院的比例较高（75% vs 74%） ；速率比 1·06，95% CI 1·02–1·10；p=0·0062)。在基线时未接受有创机械通气的患者中，达到有创机械通气复合终点或死亡的比例没有显着差异（21% vs 22 %；风险比 0·96，95% CI 0·90–1· 03；p=0·23)。使用阿司匹林与血栓事件减少（4·6% vs 5·3%；绝对减少 0·6%，SE 0·4%）和大出血事件增加相关（1·6% vs 1 ·0） %；绝对增加0·6%，SE 0·2%)。

解释

在住院的 COVID-19 患者中，阿司匹林与 28 天死亡率或进展为有创机械通气或死亡的风险降低无关，但与 28 天内存活出院率小幅增加有关。

资金

英国研究与创新（医学研究委员会）、国家健康研究所和 Wellcome Trust 通过 COVID-19 治疗加速器。