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Effect of bromhexine in hospitalized patients with COVID-19
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  1. Ramin Tolouian1,
  2. Zuber D Mulla2,
  3. Hamidreza Jamaati3,
  4. Abdolreza Babamahmoodi4,
  5. Majid Marjani5,
  6. Raha Eskandari3,
  7. Farzaneh Dastan6
  1. 1Renal Section, Southern Arizona VA Health Care System, University of Arizona, Tucson, Arizona, USA
  2. 2Department of Obstetrics and Gynecology, and Office of Faculty Development, Paul L. Foster School of Medicine, Texas Tech University Health Sciences Center El Paso, El Paso, Texas, USA
  3. 3Chronic Respiratory Diseases Research Center (CRDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran
  4. 4Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  5. 5Clinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  6. 6Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  1. Correspondence to Dr Farzaneh Dastan, Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran; fzh.dastan{at}gmail.com

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.

  • COVID-19
  • renal insufficiency
  • death

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Footnotes

  • Contributors RT, ZDM, and FD were involved in design, analysis of data and drafting of the manuscript. HJ, AB, MM and RE were involved in recruiting patients, management and follow up. Data collection was done by AB and FD. All authors read and signed the final paper.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval The study was approved by the ethics committee of the Shahid Beheshti University of Medical Sciences, Tehran, Iran (IR.SBMU.NRITLD.REC.1399.142).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information. The deidentified subject data are available in a secure space under the control of corresponding author [fzh.dastan@gmail.com].

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