Melatonin effects on sleep quality and outcomes of COVID‐19 patients: An open‐label, randomized, controlled trial
Seyed Abbas Mousavi, Keyvan Heydari, Hossein Mehravaran, Majid Saeedi, Reza Alizadeh‐navaei, Akbar Hedayatizadeh‐omran, Amir Shamshirian
Journal of Medical Virology, doi:10.1002/jmv.27312
This trial aims to evaluate the effectiveness of adding melatonin to the treatment protocol of hospitalized coronavirus disease 2019 (COVID-19) patients. This was an open-label, randomized controlled clinical trial in hospitalized COVID-19 patients. Patients were randomized into a treatment arm receiving melatonin plus standard care or a control arm receiving standard care alone. The trial's primary endpoint was sleep quality examined by the Leeds Sleep Evaluation Questionnaire (LSEQ). The trial's secondary endpoints were symptoms alleviation by Day 7, intensive care unit admission, 10-day mortality, white blood cell count, lymphocyte count, C-reactive protein status, and peripheral capillary oxygen saturation. Ninety-six patients were recruited and allocated to either the melatonin arm (n = 48) or control arm (n = 48). Baseline characteristics were similar across treatment arms. There was no significant difference in symptoms on Day 7. The mean of the LSEQ scores was significantly higher in the melatonin group (p < 0.001). There was no significant difference in laboratory data, except for blood oxygen saturation, which has improved significantly in the melatonin group compared with the control group (95.81% vs. 93.65% respectively, p = 0.003). This clinical trial study showed that the combination of oral melatonin tablets and standard treatment could substantially improve sleep quality and blood oxygen saturation in hospitalized COVID-19 patients.
CONFLICT INTERESTS The authors declare that there are no conflict interests.
ETHICS STATEMENT The trial protocol was approved by the Ethics Committee of Mazandaran University of Medical Sciences (approval number IR.MAZUMS.REC.1399.056) on April 12, 2020, and registered with the Iranian Registry of Clinical Trials (IRCT20200411047030N1).
AUTHOR CONTRIBUTIONS Seyed Abbas Mousavi, Reza Alizadeh-Navaei, Majid Saeedi, and Amir Shamshirianh designed the study. Reza Alizadeh-Navaei worked on the statistical analysis. Hossein Mehravaran, Keyvan Heydari, and Amir Shamshirianh performed the research. Amir Shamshirian wrote the first draft of the manuscript. Akbar Hedayatizadeh-Omran, Seyed Abbas Mousavi, Reza Alizadeh-Navaei, Majid Saeedi, and Hossein Mehravaran helped with the preparation of the manuscript. All authors have read and approved the final manuscript.
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