Abstract: B BioImpacts Ansarin et al, BioImpacts, 2020, 10(4), 209-215 doi: 10.34172/bi.2020.27 http://bi.tbzmed.ac.ir/ TUOMS TUOMS PRESS PRESS Publish Free ccess Effect of bromhexine on clinical outcomes and mortality in COVID-19 patients: A randomized clinical trial Khalil Ansarin1,2 , Ramin Tolouian3, Mohammadreza Ardalan4* , Ali Taghizadieh2,5, Mojtaba Varshochi6, Soheil Teimouri5, Tahere Vaezi5, Hamed Valizadeh2,5, Parviz Saleh4, Saeid Safiri7,8 , Kenneth R. Chapman9 ID ID ID ID Rahat Breath and Sleep Research Center, Tabriz University of Medical Sciences, Tabriz, Iran 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 1 2 Article Info Article Type: Original Article Article History: Received: 7 July 2020 Revised: 16 July 2020 Accepted: 18 July 2020 ePublished: 19 July 2020 Keywords: Bromhexine hydrochloride COVID-19 disease SARS-CoV2 TMPRSS2 COVID-19 pneumonia COVID-19 treatment 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, NorthWest 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.