Melatonin effects on sleep quality and outcomes of COVID-19 patients: An open-label, randomized, controlled trial
Abstract
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.
Conclusion
This clinical trial study showed that the combination of oral
melatonin tablets and standard treatment could substantially improve sleep quality and blood oxygen saturation after 7 days of treatment in hospitalized COVID-19 patients.
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,
First published: 30 August 2021
https://doi.org/10.1002/jmv.27312