The Effect of Melatonin as an Adjuvant Therapy on COVID-19: A Randomized Clinical Trial
RCT 81 hospitalized patients in Iran, showing significantly improved oxygen saturation with treatment. Melatonin 3mg, 3x daily for 2 weeks.
Davoodian et al., 1 Jul 2021, Double Blind Randomized Controlled Trial, placebo-controlled, Iran, preprint, 6 authors, trial
IRCT20200408046988N1.
Abstract: Trial
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The effect of melatonin as an adjuvant therapy on COVID-19: A Randomized Clinical
Najmeh Davoodian1,2, *, Farnoosh Sharifimood1, Davoud Salarbashi2,3,**, Sepideh Elyasi4,**,
Amir Baniasad5,**, Farhang Soltani Bejestani6
1Department
of Internal Medicine, Clinical Research Development Unit, Bohlool Hospital,
Gonabad University of Medical Sciences, Gonabad, Iran.
Diseases Research Centre, Gonabad University of Medical Sciences, Gonabad, Iran.
3Department
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2Infectious
of Nutrition and food science, School of Medicine, Gonabad University of Medical
4Department
er
r
Sciences, Gonabad, Iran.
of Clinical Pharmacy, School of Pharmacy, Mashhad University of Medical
Sciences, Mashhad, Iran.
of Internal Medicine, School of Medicine, Kerman University of Medical Sciences,
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5Department
Kerman, Iran.
6Department
of Rheumatology, Faculty of Medicine, Gonabad University of Medical Sciences,
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Gonabad, Iran
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*Corresponding to: Department of Internal Medicine, Gonabad University of Medical Sciences,
Gonabad, Iran. Email: najmeh.davoudian@gmail.com
Pr
ep
rin
**Co-corresponding author
This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=3878090
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Summary
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.
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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
er
r
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
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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
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with large sample size and on other populations like severe COVID-19 is recommended.
Funding: This article was sponsored by the Research Council of Gonabad University of Medical Sciences
Pr
ep
rin
tn
(Gonabad, Iran)
This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=3878090
iew
ed
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