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0 0.5 1 1.5 2+ Mortality 76% Improvement Relative Risk Improvement 76% Viral clearance -75% Tolouian et al. Bromhexine for COVID-19 RCT LATE Is late treatment with bromhexine beneficial for COVID-19? RCT 100 patients in Iran Worse viral clearance with bromhexine (p=0.016) Tolouian et al., J. Investig. Med., doi:10.1136/jim-2020-001747 Favors bromhexine Favors control
Effect of bromhexine in hospitalized patients with COVID-19
Tolouian et al., J. Investig. Med., doi:10.1136/jim-2020-001747
Tolouian et al., Effect of bromhexine in hospitalized patients with COVID-19, J. Investig. Med., doi:10.1136/jim-2020-001747
Mar 2021   Source   PDF  
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Small RCT with 100 patients, 48 with bromhexine added to SOC, showing slower viral- conversion but lower mortality and greater clinical improvement with bromhexine (not statistically significant with few deaths and very high recovery). The very large difference between unadjusted and adjusted results is due to much higher risk for patients with renal disease and the much higher prevalence of renal disease in the bromhexine group.
The study also shows 90% of patients in the control group had BMI>=30 compared to 0% in the treatment group, suggesting a possible problem with randomization. Due to the imbalance between groups, results were adjusted for BMI>30, smoking, and renal disease.
11 patients were lost to followup in the treatment group compared to zero in the control group, perhaps in part due to faster recovery in the treatment group. 9 patients were excluded from the treatment group because they did not want to take bromhexine after discharge. Therefore up to 29% of treatment patients may have been excluded because they recovered quickly.
Bromhexine may be less effective for omicron due to the entry process moving towards TMPRSS2-independent fusion.
risk of death, 76.0% lower, OR 0.24, p = 0.43, treatment 48, control 52, adjusted per study, Table 3, RR approximated with OR.
risk of no improvement, 75.9% better, OR 0.24, p = 0.43, treatment 48, control 52, adjusted per study, inverted to make OR<1 favor treatment, Table 2, RR approximated with OR.
risk of no viral clearance, 74.5% higher, RR 1.75, p = 0.02, treatment 29 of 48 (60.4%), control 18 of 52 (34.6%), mid-recovery day 7.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Tolouian et al., 15 Mar 2021, Randomized Controlled Trial, Iran, peer-reviewed, 7 authors.
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This PaperBromhexineAll
Abstract: Original research Effect of bromhexine in hospitalized patients with COVID-19 Ramin Tolouian ‍ ‍,1 Zuber D Mulla ‍ ‍,2 Hamidreza Jamaati,3 Abdolreza Babamahmoodi,4 Majid Marjani,5 Raha Eskandari,3 Farzaneh Dastan6 For numbered affiliations see end of article. Correspondence to Dr Farzaneh Dastan, Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran; ​fzh.​dastan@​gmail.​com Accepted 24 February 2021 © American Federation for Medical Research 2021. No commercial re-­use. See rights and permissions. Published by BMJ. To cite: Tolouian R, Mulla ZD, Jamaati H, et al. J Investig Med Epub ahead of print: [please include Day Month Year]. doi:10.1136/jim-2020001747 ABSTRACT Background Bromhexine is a potent inhibitor of transmembrane serine protease 2 and appears to have an antiviral effect in controlling influenza and parainfluenza infection; however, its efficacy in COVID-19 is controversial. Methods A group of hospitalized patients with confirmed COVID-19 pneumonia were randomized using 1:1 allocation to either standard treatment lopinavir/ritonavir and interferon beta-­1a or bromhexine 8 mg four times a day in addition to standard therapy. The primary outcome was clinical improvement within 28 days, and the secondary outcome measures were time to hospital discharge, all-­cause mortality, duration of mechanical ventilation, the temporal trend in 2019-­nCoV reverse transcription-­polymerase chain reaction positivity and the frequency of adverse drug events within 28 days from the start of medication. Results A total of 111 patients were enrolled in this randomized clinical trial and data from 100 patients (48 patients in the treatment arm and 52 patients in the control arm) were analyzed. There was no significant difference in the primary outcome of this study, which was clinical improvement. There was no significant difference in the average time to hospital discharge between the two arms. There were also no differences observed in the mean intensive care unit stay, frequency of intermittent mandatory ventilation, duration of supplemental oxygenation or risk of death by day 28 noted between the two arms. Conclusion Bromhexine is not an effective treatment for hospitalized patients with COVID-19. The potential prevention benefits of bromhexine in asymptomatic postexposure or with mild infection managed in the community remain to be determined.
Late treatment
is less effective
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