lancet-header

Preprints with The Lancet is part of SSRN´s First Look, a place where journals identify content of interest prior to publication. Authors have opted in at submission to The Lancet family of journals to post their preprints on Preprints with The Lancet. The usual SSRN checks and a Lancet-specific check for appropriateness and transparency have been applied. Preprints available here are not Lancet publications or necessarily under review with a Lancet journal. These preprints are early stage research papers that have not been peer-reviewed. The findings should not be used for clinical or public health decision making and should not be presented to a lay audience without highlighting that they are preliminary and have not been peer-reviewed. For more information on this collaboration, see the comments published in The Lancet about the trial period, and our decision to make this a permanent offering, or visit The Lancet´s FAQ page, and for any feedback please contact preprints@lancet.com.

The Effect of Melatonin as an Adjuvant Therapy on COVID-19: A Randomized Clinical Trial

17 Pages Posted: 1 Jul 2021

See all articles by Najmeh Davoodian

Najmeh Davoodian

Gonabad University of Medical Sciences - Department of Internal Medicine; Gonabad University of Medical Sciences - Infectious Diseases Research Centre

Farnoosh Sharifimood

Gonabad University of Medical Sciences

Davoud Salarbashi

Gonabad University of Medical Sciences

Sepideh Elyasi

Mashhad University of Medical Sciences

Amir Baniasad

Kerman University of Medical Sciences

Farhang Soltani Bejestani

Gonabad University of Medical Sciences

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

Davoodian, Najmeh and Sharifimood, Farnoosh and Salarbashi, Davoud and Elyasi, Sepideh and Baniasad, Amir and Bejestani, Farhang Soltani, The Effect of Melatonin as an Adjuvant Therapy on COVID-19: A Randomized Clinical Trial. Available at SSRN: https://ssrn.com/abstract=3878090 or http://dx.doi.org/10.2139/ssrn.3878090

Najmeh Davoodian (Contact Author)

Gonabad University of Medical Sciences - Department of Internal Medicine ( email )

Gonabad
Iran

Gonabad University of Medical Sciences - Infectious Diseases Research Centre

Gonabad
Iran

Farnoosh Sharifimood

Gonabad University of Medical Sciences ( email )

Gonabad
Iran

Davoud Salarbashi

Gonabad University of Medical Sciences ( email )

Gonabad
Iran

Sepideh Elyasi

Mashhad University of Medical Sciences ( email )

Mashhad
Iran

Amir Baniasad

Kerman University of Medical Sciences ( email )

Kerman
Iran

Farhang Soltani Bejestani

Gonabad University of Medical Sciences ( email )

Gonabad
Iran

Click here to go to TheLancet.com

Paper statistics

Abstract Views
574
Downloads
126
PlumX Metrics