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Clinical trial to test the efficacy of melatonin in COVID-19.
Journal of Pineal Research ( IF 10.3 ) Pub Date : 2020-08-08 , DOI: 10.1111/jpi.12683
Dario Acuña-Castroviejo 1, 2 , Germaine Escames 1, 2 , Juan C Figueira 3 , Pedro de la Oliva 4, 5 , Alberto M Borobia 5, 6 , Carlos Acuña-Fernández 7
Affiliation  

The pharmacological properties of melatonin are well known. However, there is noticeable the lack of clinical trials that confirm the efficacy, security, absence of side effects in the short and long term, and the effective doses of melatonin. This point is especially important in diseases with high morbidity and mortality including COVID‐19. There is not treatment for COVID‐19, and several anti‐inflammatory and antiviral molecules are being tested, and different vaccines are in preparation. Although the SARS‐CoV‐2 pandemic is apparently improving, it is expected new resurges next fall. Thus, looking for an effective treatment of COVID‐19 is mandatory. Melatonin has significant anti‐inflammatory, antioxidant, and mitochondrial protective effects, and its efficacy has been demonstrated in multiple experimental models of disease and in a clinical trial in sepsis. Because COVID‐19 courses with a severe septic response, multiple reviews proposing melatonin as a treatment for COVID‐19 have been published. Nevertheless, there is a lack of experimental and clinical data on the use of melatonin on SARS‐CoV‐2 infection. Accordingly, we designed a clinical trial with an injectable formulation of melatonin for intravenous perfusion in ICU patients suffering from COVID‐19 that has been just approved by the Spanish Agency of Medicines and Medical Devices (AEMPS). The trial will allow by the first time understand the doses and efficacy of melatonin against COVID‐19.

中文翻译:

临床试验测试褪黑激素在COVID-19中的功效。

褪黑激素的药理特性是众所周知的。然而,值得注意的是,缺乏临床试验来证实其功效,安全性,短期和长期无副作用以及褪黑激素的有效剂量。这一点在包括COVID-19在内的高发病率和高死亡率的疾病中尤其重要。目前尚无COVID-19的治疗方法,并且正在测试几种抗炎和抗病毒分子,并且正在准备不同的疫苗。尽管SARS-CoV-2流行病明显改善,但预计明年秋天将有新的爆发。因此,必须寻求有效的COVID-19治疗方法。褪黑素具有显着的抗炎,抗氧化和线粒体保护作用,其功效已在多种疾病实验模型和败血症的临床试验中得到证明。由于COVID-19课程具有严重的败血反应,因此已发表了许多建议将褪黑激素治疗COVID-19的评论。然而,缺乏关于褪黑素治疗SARS-CoV-2感染的实验和临床数据。因此,我们设计了一项临床试验,该试验采用褪黑素注射剂对ICU患COVID-19的ICU患者进行静脉灌注,该试验刚刚获得西班牙医学和医疗器械局(AEMPS)的批准。该试验将使您首次了解褪黑激素对抗COVID-19的剂量和功效。已有多篇建议将褪黑激素治疗COVID-19的评论发表。然而,缺乏关于褪黑素治疗SARS-CoV-2感染的实验和临床数据。因此,我们设计了一项临床试验,该试验采用褪黑素注射剂对ICU患COVID-19的ICU患者进行静脉灌注,该试验刚刚获得西班牙医学和医疗器械局(AEMPS)的批准。该试验将使您首次了解褪黑激素对COVID-19的剂量和疗效。已有多篇建议将褪黑激素治疗COVID-19的评论发表。然而,缺乏关于褪黑素治疗SARS-CoV-2感染的实验和临床数据。因此,我们设计了一项临床试验,该试验采用褪黑素注射剂对ICU患COVID-19的ICU患者进行静脉灌注,该试验刚刚获得西班牙医学和医疗器械局(AEMPS)的批准。该试验将使您首次了解褪黑激素对COVID-19的剂量和疗效。我们设计了一种褪黑激素注射剂临床试验,该试验已通过西班牙药品和医疗器械局(AEMPS)批准,可用于ICU患COVID-19的ICU患者的静脉内灌注。该试验将使您首次了解褪黑激素对COVID-19的剂量和疗效。我们设计了一种褪黑激素注射剂临床试验,该试验已通过西班牙药品和医疗器械局(AEMPS)批准,可用于ICU患COVID-19的ICU患者的静脉内灌注。该试验将使您首次了解褪黑激素对COVID-19的剂量和疗效。
更新日期:2020-09-20
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