Applied Biotechnology Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran.
Applied Microbiology Research Center, Systems Biology and poisonings Institute, Baqiyatallah university of Medical Sciences, Tehran, Iran.
Arch Med Res. 2022 Jan;53(1):79-85. doi: 10.1016/j.arcmed.2021.06.006. Epub 2021 Jun 23.
Melatonin has been known as an anti-inflammatory agent and immune modulator that may address progressive pathophysiology of coronavirus disease 2019 (COVID-19).
To evaluate the clinical efficacy of adjuvant, use of melatonin in patients with COVID-19.
This single-center, double-blind, randomized clinical trial included 74 hospitalized patients with confirmed mild to moderate COVID-19 at Baqiyatallah Hospital in Tehran, Iran, from April 25, 2020-June 5, 2020. Patients were randomly assigned in a 1:1 ratio to receive standard of care and standard of care plus melatonin at a dose of 3 mg three times daily for 14 d. Clinical characteristics, laboratory, and radiological findings were assessed and compared between two study groups at baseline and post-intervention. Safety and clinical outcomes were followed up for four weeks.
A total of 24 patients in the intervention group and 20 patients in the control group completed the treatment. Compared with the control group, the clinical symptoms such as cough, dyspnea, and fatigue, as well as the level of CRP and the pulmonary involvement in the intervention group had significantly improved (p <0.05). The mean time of hospital discharge of patients and return to baseline health was significantly shorter in the intervention group compared to the control group (p <0.05). No deaths and adverse events were observed in both groups.
Adjuvant use of melatonin has a potential to improve clinical symptoms of COVID-19 patients and contribute to a faster return of patients to baseline health.
褪黑素作为一种抗炎和免疫调节剂，可治疗 2019 年冠状病毒病（COVID-19）的进行性病理生理学。
评估辅助使用褪黑素治疗 COVID-19 患者的临床疗效。
这是一项单中心、双盲、随机临床试验，纳入了 2020 年 4 月 25 日至 6 月 5 日期间伊朗德黑兰巴奇亚塔拉拉医院确诊为轻度至中度 COVID-19 的 74 例住院患者。患者按 1:1 比例随机分为对照组和褪黑素组，分别接受标准治疗和标准治疗加褪黑素（剂量为 3mg，每日 3 次），疗程 14 天。在基线和干预后评估并比较两组患者的临床特征、实验室和影像学检查结果。随访 4 周以评估安全性和临床结局。
干预组共有 24 例患者和对照组 20 例患者完成了治疗。与对照组相比，干预组的咳嗽、呼吸困难和疲劳等临床症状以及 CRP 水平和肺部受累均明显改善（p<0.05）。与对照组相比，干预组患者的住院时间和恢复到基线健康的时间明显缩短（p<0.05）。两组均未观察到死亡和不良反应。
辅助使用褪黑素可能改善 COVID-19 患者的临床症状，有助于患者更快地恢复到基线健康。
