Efficacy of a Low Dose of Melatonin as an Adjunctive Therapy in
Hospitalized Patients with COVID-19: A Randomized, Double-blind Clinical
Trial
Abstract
Abstract Aim: To evaluate the clinical efficacy of adjuvant use of
melatonin in patients with coronavirus disease 2019 (COVID-19). Methods:
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 to 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 days. 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. Results: 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 during this
study. Conclusions: 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. Keywords: COVID-19, Melatonin, Clinical
trial, Adjunctive therapy Trial Registration: ClinicalTrials.gov
Identifier: NCT04409522