Tabriz University of Medical Sciences BioImpacts 2228-5652 10 4 2020 09 08 Effect of bromhexine on clinical outcomes and mortality in COVID-19 patients: A randomized clinical trial 209 215 10.34172/bi.2020.27 EN Khalil Ansarin https://orcid.org/0000-0002-3114-5224 Ramin Tolouian Mohammadreza Ardalan https://orcid.org/0000-0002-6851-5460 Ali Taghizadieh Mojtaba Varshochi Soheil Teimouri Tahere Vaezi Hamed Valizadeh Parviz Saleh Saeid Safiri https://orcid.org/0000-0001-7986-9072 Kenneth R. Chapman https://orcid.org/0000-0002-2498-9859 Journal Article 10.34172/bi.2020.27 2020 07 07 2020 07 18 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 No patients were withdrawn from the study because of adverse effects.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.