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The Effect of Melatonin as an Adjuvant Therapy on COVID-19: A Randomized Clinical Trial
17 Pages Posted: 1 Jul 2021
More...Abstract
Background: Melatonin is secreted by the pineal gland and has antioxidant and anti-inflammatory properties. So, it is proposed to be effective in the management of Coronavirus disease 2019 (COVID-19). This study aimed to evaluate the effect of melatonin as adjunctive therapy for the treatment of hospitalized patients with mild to moderate COVID-19.MethodsIn this double-blind randomized placebo controlled clinical trial, 81 mild to moderate hospitalized COVID-19 patients with inclusion criteria were randomly divided to treatment (n=42) group to receive melatonin tablet 3 mg, three times daily for 2 weeks or placebo (n=39) group. Patients’ symptoms and laboratory data were assessed at baseline and during the follow-up period and compared between two groups.
Findings: After two weeks of follow-up, the oxygen saturation and the respiratory rate significantly improved in the melatonin group. Moreover, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), lactate dehydrogenase (LDH), creatine phosphokinase (CPK), Ferritin, and D-Dimer levels significantly decreased in the melatonin group, but there was a considerable increase in the placebo group. Between-group comparison showed a significant difference between melatonin and placebo groups.
Interpretation: The results of this randomized, double-blind, placebo-controlled trial indicated the high efficacy and safety of melatonin as an adjuvant therapy in patients with mild to moderate COVID-19 disease. Further study with large sample size and on other populations like severe COVID-19 is recommended.
Trial Registration: This study is also registered in the Iranian Registry of Clinical Trials (IRCT registration number: IRCT20200408046988N1). Study protocol link: https://en.irct.ir/trial/47142.
Funding: This article was sponsored by the Research Council of Gonabad University of Medical Sciences (Gonabad, Iran)
Declaration of Interest: None to declare.
Ethical Approval: The ethics committee of Gonabad University of Medical Sciences approved the protocol of this study (Code: IR.GMU.REC.1399.016)
Suggested Citation: Suggested Citation