Effect of bromhexine on clinical outcomes and mortality in COVID-19 patients: A randomized clinical trial

Abstract

<b><i>Introduction:</i></b> 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. <i><b>Methods:</b></i> 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. <i><b>Results:</b></i> 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, <i>P</i> = 0.006), intubation (1 out of 39 vs. 9 out of 39, <i>P</i> = 0.007) and death (0 vs. 5, <i>P</i> = 0.027) in the bromhexine treated group compared to the standard group. No patients were withdrawn from the study because of adverse effects. <i><b>Conclusion:</b></i> 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. <i><b>Trial Registration:</b></i> IRCT202003117046797N4; https://irct.ir/trial/46969.