The effect of melatonin as an adjuvant therapy on COVID-19: A Randomized Clinical Trial
Najmeh Davoodian, Farnoosh Sharifimood, Davoud Salarbashi, Sepideh Elyasi, Amir Baniasad, Farhang Soltani Bejestani
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.
Methods: In 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.
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