Thale D. J. Hovdun Patrick-Brown, Andreas Barratt-Due, Marius Trøseid, Anne Ma Dyrhol-Riise, Katerina Nezvalova-Henriksen, Trine Kåsine, Pål Aukrust, Inge C. Olsen, NOR Solidarity consortium
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A total of 185 patients were included in the main trial, of which 118 (60%) were randomised to either remdesivir (n = 42; 36%) or a post-hoc defined control group composed of patients who received standard of care alone or standard of care with hydroxychloroquine (n = 76; 64%). Participants were given quality of life surveys to fill out to gauge their self-reported health over time (the COPD assessment test, the EQ-5D-5L and the RAND SF-36). Here we show that after three months, patients treated with remdesivir do not show significant improvements in stated health compared to those who were not. There are self-reported symptoms of fatigue [mean remdesivir group 2.6 (standard deviation 1.5) v control 2.1 (1.6), 95% confidence interval(CI) −1.17 to 0.15, p = 0.129], shortness of breath [3.0 (1.7) v 2.1 (1.8), 95% CI −1.53 to 0.16, p = 0.110] and coughing [1.8 (1.6) v 1.2 (1.5), 95% CI −1.3 to 0.33, p = 0.237] 3 months after randomisation assessed via the COPD Assessment Test. 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引用次数: 0
摘要
背景:治疗 COVID-19 后长期症状的需求尚未得到满足。雷米替韦是目前欧洲药品管理局批准用于住院患者的唯一抗病毒药物。在此,我们报告了雷米替韦在标准护理基础上对 COVID-19 住院患者长期症状和生活质量的影响,这是开放标签随机 NOR-Solidarity 试验(NCT04321616)的一部分:主要试验共纳入了185名患者,其中118人(60%)被随机分配到雷米地韦组(n = 42;36%)或由单独接受标准护理或标准护理加羟氯喹的患者组成的事后定义对照组(n = 76;64%)。参试者需填写生活质量调查表,以评估其自我健康状况(慢性阻塞性肺病评估测试、EQ-5D-5L 和 RAND SF-36):结果:我们在此表明,与未接受治疗的患者相比,接受雷米替韦治疗三个月后,患者的健康状况并没有明显改善。自我报告的症状包括疲劳[平均雷米替韦组 2.6(标准差 1.5)v 对照组 2.1(1.6),95% 置信区间(CI)-1.17 至 0.15,p = 0.129]、气短[3.0(1.7) v 2.1 (1.8), 95% CI -1.53 to 0.16, p = 0.110]和咳嗽[1.8 (1.6) v 1.2 (1.5), 95% CI -1.3 to 0.33, p = 0.237]:我们的研究结果表明,住院期间使用雷米替韦治疗不会带来任何临床相关的长期益处。
The effects of remdesivir on long-term symptoms in patients hospitalised for COVID-19: a pre-specified exploratory analysis
There is an unmet need for treatment of long-term symptoms following COVID-19. Remdesivir is currently the only antiviral approved by the European Medicines Agency for hospitalised patients. Here, we report on the effect of remdesivir in addition to standard of care on long-term symptoms and quality of life in hospitalised patients with COVID-19 as part of the open-label randomised NOR-Solidarity trial (NCT04321616). A total of 185 patients were included in the main trial, of which 118 (60%) were randomised to either remdesivir (n = 42; 36%) or a post-hoc defined control group composed of patients who received standard of care alone or standard of care with hydroxychloroquine (n = 76; 64%). Participants were given quality of life surveys to fill out to gauge their self-reported health over time (the COPD assessment test, the EQ-5D-5L and the RAND SF-36). Here we show that after three months, patients treated with remdesivir do not show significant improvements in stated health compared to those who were not. There are self-reported symptoms of fatigue [mean remdesivir group 2.6 (standard deviation 1.5) v control 2.1 (1.6), 95% confidence interval(CI) −1.17 to 0.15, p = 0.129], shortness of breath [3.0 (1.7) v 2.1 (1.8), 95% CI −1.53 to 0.16, p = 0.110] and coughing [1.8 (1.6) v 1.2 (1.5), 95% CI −1.3 to 0.33, p = 0.237] 3 months after randomisation assessed via the COPD Assessment Test. Our findings indicate that treatment with remdesivir during hospitalisation does not provide any clinically relevant long-term benefit. Remdesivir is a medicine that is used to treat people with COVID-19. It has been found to help people get better faster, but we did not know whether it also relieved them of long-term symptoms such as persistent coughing, fatigue, or shortness of breath. To research this, we randomly assigned hospitalised patients with COVID-19 to either remdesivir on top of their normal care, or only normal care, with or without hydroxychloroquine (a drug later found to have no effect on COVID-19). We then compared participant’s symptoms after 3 months. Our results show that there is probably no benefit of using remdesivir during hospitalisation for long-term symptom relief. Patrick-Brown et al report the findings of a secondary study adjunct to the Nor-Solidarity trial that evaluated remdesivir versus standard of care for the treatment of COVID-19. While remdesivir appears to be safe for use in these patients, there does not appear to be any long-term clinical benefit to its use in terms of long-COVID symptoms.