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

• Published in: Bioimpacts 2020-01, Vol.10 (4), p.209-215
• Main Authors: Ansarin, Khalil, Tolouian, Ramin, Ardalan, Mohammadreza, Taghizadieh, Ali, Varshochi, Mojtaba, Teimouri, Soheil, Vaezi, Tahere, Valizadeh, Hamed, Saleh, Parviz, Safiri, Saeid, Chapman, Kenneth R
• Format: Article
• Language: English
• Subjects: Clinical outcomes; Clinical trials; Coronaviruses; COVID-19; Dyspnea; Infections; Intensive care; Intubation; Mechanical ventilation; Mortality; Oxygen saturation; Patient admissions; Patients; Pneumonia; Public health; Severe acute respiratory syndrome coronavirus 2; Statistical analysis; Ventilators; Viruses
• ISSN: 2228-5652; 2228-5660
• DOI: 10.34172/Ы.2020.27

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 No patients were withdrawn from the study because of adverse effects.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.