Effect of bromhexine on clinical outcomes and mortality in COVID-19 patients: A randomized clinical trial
Ansarin et al.
, Effect of bromhexine on clinical outcomes and mortality in COVID-19 patients: A randomized clinical trial
, Bioimpacts, doi:10.34172/bi.2020.27
RCT with 39 bromhexine and 39 control patients showing lower mortality, intubation, and ICU admission with treatment. The treatment group received bromhexine hydrochloride 8 mg three times a day for two weeks. All patients received SOC including HCQ.
Bromhexine may be less effective for omicron due to the entry process moving towards TMPRSS2-independent fusion.
risk of death, 90.9% lower, RR 0.09, p = 0.05, treatment 0 of 39 (0.0%), control 5 of 39 (12.8%), NNT 7.8, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
risk of mechanical ventilation, 88.9% lower, RR 0.11, p = 0.01, treatment 1 of 39 (2.6%), control 9 of 39 (23.1%), NNT 4.9.
risk of ICU admission, 81.8% lower, RR 0.18, p = 0.01, treatment 2 of 39 (5.1%), control 11 of 39 (28.2%), NNT 4.3.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Ansarin et al., 19 Jul 2020, Randomized Controlled Trial, Iran, peer-reviewed, 11 authors.
Ansarin et al, BioImpacts, 2020, 10(4), 209-215
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
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
Division of Nephrology, University of Arizona, Tucson, AZ, USA
Kidney Research Center, Tabriz University of Medical Sciences, Tabriz, Iran
Department of Internal Medicine, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
Infectious and Tropical Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran
Department of Community Medicine, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
Physical Medicine and Rehabilitation Research Center, Aging Research Institute, Tabriz University of Medical Sciences, Tabriz, Iran
Asthma and Airway Center, University Health Network, University of Toronto, Toronto, ON, Canada
Received: 7 July 2020
Revised: 16 July 2020
Accepted: 18 July 2020
ePublished: 19 July 2020
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
Trial Registration: IRCT202003117046797N4; https://irct.ir/trial/46969.
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