Khalil Ansarin
1,2 
, Ramin Tolouian
3, Mohammadreza Ardalan
4* , Ali Taghizadieh
2,5, Mojtaba Varshochi
6, Soheil Teimouri
5, Tahere Vaezi
5, Hamed Valizadeh
2,5, Parviz Saleh
4, Saeid Safiri
7,8 , Kenneth R. Chapman
9 1 Rahat Breath and Sleep Research Center, Tabriz University of Medical Sciences, Tabriz, Iran
2 Tuberculosis and Lung Disease Research Center, Tabriz University of Medical Sciences, Tabriz, Iran
3 Division of Nephrology, University of Arizona, Tucson, AZ, USA
4 Kidney Research Center, Tabriz University of Medical Sciences, Tabriz, Iran
5 Department of Internal Medicine, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
6 Infectious and Tropical Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran
7 Department of Community Medicine, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
8 Physical Medicine and Rehabilitation Research Center, Aging Research Institute, Tabriz University of Medical Sciences, Tabriz, Iran
9 Asthma and Airway Center, University Health Network, University of Toronto, Toronto, ON, Canada
Abstract
Introduction: Bromhexine is a potential therapeutic option in COVID-19, but no data from a randomized clinical trial has been available. The present study aimed to evaluate the efficacy of bromhexine in intensive care unit (ICU) admission, mechanical ventilation, and mortality in patients with COVID-19.
Methods: An open-label randomized clinical trial study was performed in Tabriz, North-West of Iran. They were randomized to either the treatment with the bromhexine group or the control group, in a 1:1 ratio with 39 patients in each arm. Standard therapy was used in both groups and those patients in the treatment group received oral bromhexine 8 mg three times a day additionally. The primary outcome was a decrease in the rate of ICU admissions, intubation/mechanical ventilation, and mortality.
Results: A total of 78 patients with similar demographic and disease characteristics were enrolled. There was a significant reduction in ICU admissions (2 out of 39 vs. 11 out of 39, P = 0.006), intubation (1 out of 39 vs. 9 out of 39, P = 0.007) and death (0 vs. 5, P = 0.027) in the bromhexine treated group compared to the standard group. No patients were withdrawn from the study because of adverse effects.
Conclusion: The early administration of oral bromhexine reduces the ICU transfer, intubation, and the mortality rate in patients with COVID-19. This affordable medication can easily be administered everywhere with a huge positive impact(s) on public health and the world economy. Altogether, the verification of our results on a larger scale and different medical centers is strongly recommended.
Trial Registration: IRCT202003117046797N4; https://irct.ir/trial/46969.