Efficacy of a Low Dose of Melatonin as an Adjunctive Therapy in Hospitalized Patients with COVID-19: A Randomized, Double-blind Clinical Trial
Farnoosh et al.,
Efficacy of a Low Dose of Melatonin as an Adjunctive Therapy in Hospitalized Patients with COVID-19: A..,
Archives of Medical Research, doi:10.1016/j.arcmed.2021.06.006
RCT 44 hospitalized patients in Iran, 24 treated with melatonin, showing faster recovery with treatment. There was no mortality.
risk of ICU admission, 81.5% lower, RR 0.19, p = 0.20, treatment 0 of 24 (0.0%), control 2 of 20 (10.0%), NNT 10.0, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
|
recovery time, 49.0% lower, relative time 0.51, p = 0.004, treatment 24, control 20.
|
risk of no hospital discharge, 44.4% lower, RR 0.56, p = 0.65, treatment 2 of 24 (8.3%), control 3 of 20 (15.0%), NNT 15.
|
time to discharge, 42.9% lower, relative time 0.57, p = 0.02, treatment 24, control 20.
|
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
|
Farnoosh et al., 23 Jun 2021, Double Blind Randomized Controlled Trial, Iran, peer-reviewed, 12 authors, average treatment delay 7.0 days.
Abstract: ARTICLE IN PRESS
JID: ARCMED
[mNS;July 3, 2021;15:24]
Archives of Medical Research xxx (xxxx) xxx
Efficacy of a Low Dose of Melatonin as an Adjunctive Therapy in
Hospitalized Patients with COVID-19: A Randomized, Double-blind
Clinical Trial
Gholamreza Farnoosh,a Mostafa Akbariqomi,b Taleb Badri,c Mahdi Bagheri,d Morteza Izadi,d
Ali Saeedi-Boroujeni,e Ehsan Rezaie,f Hadi Esmaeili Gouvarchin Ghaleh,g Hossein Aghamollaei,h
Mahdi Fasihi-ramandi,f Kazem Hassanpour,i and GholamHossein Alishirih,∗
a Applied
Biotechnology Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran
Microbiology Research Center, Systems Biology and poisonings Institute, Baqiyatallah university of Medical Sciences, Tehran, Iran
c Neuroscience Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran
d Health Research Center, Life Style Institute, Baqiyatallah University of Medical Sciences, Tehran, Iran
e Department of Immunology, Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
f Molecular Biology Research Center, Systems Biology and Poisonings Institute, Baqiyatallah University of Medical Sciences, Tehran, Iran
g Applied Virology Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran
h Chemical Injuries Research Center, Systems Biology and Poisonings Institute, Baqiyatallah University of Medical Sciences, Tehran, Iran
i Department of Pediatric, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran
b Applied
Received for publication February 27, 2021; accepted June 17, 2021 (ARCMED_2021_2680).
Abstract
Background. Melatonin has been known as an anti-inflammatory agent and immune
modulator that may address progressive pathophysiology of coronavirus disease 2019
(COVID-19).Aim of the study. To evaluate the clinical efficacy of adjuvant, use of
melatonin in patients with 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–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 d. 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.
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.
© 2021 Instituto Mexicano del Seguro Social (IMSS). Published by Elsevier Inc. All
rights reserved.
Keywords: COVID-19, Melatonin, Clinical trial, Adjunctive therapy.
0188-4409/$ - see front matter. Copyright © 2021 Instituto Mexicano del Seguro Social (IMSS). Published by..
Late treatment
is less effective
Please send us corrections, updates, or comments. Vaccines and
treatments are complementary. All practical, effective, and safe means should
be used based on risk/benefit analysis. No treatment, vaccine, or intervention
is 100% available and effective for all current and future variants. We do not
provide medical advice. Before taking any medication, consult a qualified
physician who can provide personalized advice and details of risks and
benefits based on your medical history and situation.
FLCCC and
WCH
provide treatment protocols.
Submit