Statin and aspirin as adjuvant therapy in hospitalised patients with SARS-CoV-2 infection: a randomised clinical trial (RESIST trial).
Statin and aspirin as adjuvant therapy in hospitalised patients with SARS-CoV-2 infection: a randomised clinical trial (RESIST trial).
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DOI：
10.1186/s12879-022-07570-5
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发表时间：
2022-07-09
影响因子：
3.7
通讯作者：
Deepti, Siddharthan
中科院分区：
文献类型：
--
作者：
Ghati, Nirmal;Bhatnagar, Sushma;Mahendran, Manjit;Thakur, Abhishek;Prasad, Kshitij;Kumar, Devesh;Dwivedi, Tanima;Mani, Kalaivani;Tiwari, Pawan;Gupta, Ritu;Mohan, Anant;Saxena, Anita;Guleria, Randeep;Deepti, Siddharthan
他汀类药物和阿司匹林因其抗炎和抗血栓特性而被提议用于治疗 COVID-19。多项观察性研究显示出良好的结果。需要进行随机对照试验。在这项单中心、开放标签、随机对照试验中，900 名需要住院治疗的 RT-PCR 阳性 COVID-19 患者被随机分配接受阿托伐他汀 40 mg（A 组，n = 224）、阿司匹林 75 mg（B 组，n = 225）或两者均服用（C 组，n = 225）以及标准护理10 天或直至出院，以较早者或仅标准护理为准（D 组，n = 226）。主要结局变量是根据 WHO 临床改善标准量表 ≥ 6 的临床恶化。次要结局是血清 C 反应蛋白、白细胞介素 6 和肌钙蛋白 I 的变化。主要结局发生在 25 名 (2.8%) 患者中：A 组 7 例 (3.2%)，B 组 3 例 (1.4%)，C 组 8 例 (3.6%)， D 组有 7 名 (3.2%)。各研究组的主要结局没有差异 (P = 0.463)。所有接受阿托伐他汀或阿司匹林治疗的患者与对照组（D 组）的比较也没有显示出任何获益 [阿托伐他汀：HR 1.0 (95% CI 0.41–2.46) P = 0.99；阿司匹林：HR 0.7 (95% CI 0.27–1.81) P = 0.46]。次要结局显示 B 组和 C 组患者的血清白细胞介素 6 水平较低。没有出现过多的不良事件。在患有轻度至中度 COVID-19 感染的患者中，使用阿司匹林、阿托伐他汀或两者联合治疗并不能防止临床恶化。试验注册号 CTRI/2020/07/026791（http://ctri.nic.in；注册于 2020 年 7 月 25 日）在线版本包含可在 10.1186/s12879-022-07570-5 获取的补充材料。
Statins and aspirin have been proposed for treatment of COVID-19 because of their anti-inflammatory and anti-thrombotic properties. Several observational studies have shown favourable results. There is a need for a randomised controlled trial. In this single-center, open-label, randomised controlled trial, 900 RT-PCR positive COVID-19 patients requiring hospitalisation, were randomly assigned to receive either atorvastatin 40 mg (Group A, n = 224), aspirin 75 mg (Group B, n = 225), or both (Group C, n = 225) in addition to standard of care for 10 days or until discharge whichever was earlier or only standard of care (Group D, n = 226). The primary outcome variable was clinical deterioration to WHO Ordinal Scale for Clinical Improvement ≥ 6. The secondary outcome was change in serum C-reactive protein, interleukin-6, and troponin I. The primary outcome occurred in 25 (2.8%) patients: 7 (3.2%) in Group A, 3 (1.4%) in Group B, 8 (3.6%) in Group C, and 7 (3.2%) in Group D. There was no difference in primary outcome across the study groups (P = 0.463). Comparison of all patients who received atorvastatin or aspirin with the control group (Group D) also did not show any benefit [Atorvastatin: HR 1.0 (95% CI 0.41–2.46) P = 0.99; Aspirin: HR 0.7 (95% CI 0.27–1.81) P = 0.46]. The secondary outcomes revealed lower serum interleukin-6 levels among patients in Groups B and C. There was no excess of adverse events. Among patients admitted with mild to moderate COVID-19 infection, additional treatment with aspirin, atorvastatin, or a combination of the two does not prevent clinical deterioration. Trial Registry Number CTRI/2020/07/026791 (http://ctri.nic.in; registered on 25/07/2020) The online version contains supplementary material available at 10.1186/s12879-022-07570-5.
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影响因子：
6.4
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