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Bromhexine Hydrochloride Tablets for the Treatment of Moderate COVID-19: An Open-Label Randomized Controlled Pilot
Ting Li1,2, Laifang Sun3, Wenwu Zhang4
1Department of Anesthesia and Critical Care, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.
Insights
Bromhexine hydrochloride (BRH) tablets show potential benefits for COVID-19 patients, particularly those with lung or liver issues. Further large-scale trials are needed to confirm efficacy and safety in treating coronavirus disease 2019.
Area of Science:
- Pharmacology
- Infectious Diseases
- Clinical Trials
Background:
- Mild to moderate coronavirus disease 2019 (COVID-19) requires effective treatment options.
- Bromhexine hydrochloride (BRH) is a mucolytic agent with potential anti-inflammatory properties.
Purpose of the Study:
- To assess the feasibility of a clinical trial for bromhexine hydrochloride (BRH) tablets in COVID-19 patients.
- To explore the clinical efficacy and safety of BRH as an adjunct treatment for mild or moderate COVID-19.
Main Methods:
- An open-label, randomized controlled pilot study design.
- 18 patients with moderate COVID-19 were randomized (2:1 ratio) into BRH or control groups.
- BRH group received 32 mg oral BRH three times daily for 14 days, alongside standard care.
Main Results:
- The study demonstrated feasibility for a larger trial.
- Trends suggested potential BRH advantages in chest imaging, oxygen therapy needs, and discharge rates within 20 days.
- No statistically significant differences were observed between the BRH and control groups.
Conclusions:
- Bromhexine hydrochloride (BRH) tablets may offer a beneficial effect for COVID-19 patients, especially those with lung or hepatic injury.
- The pilot study indicates that a definitive, large-scale clinical trial is both feasible and necessary to confirm these preliminary findings.
Abstract:
This open-label randomized controlled pilot study aimed to test the study feasibility of bromhexine hydrochloride (BRH) tablets for the treatment of mild or moderate coronavirus disease 2019 (COVID-19) and to explore its clinical efficacy and safety. Patients with mild or moderate COVID-19 were randomly divided into the BRH group or the control group at a 2:1 ratio. Routine treatment according to China's Novel Coronavirus Pneumonia Diagnosis and Treatment Plan was performed in both groups, whereas patients in the BRH group were additionally given oral BRH (32 mg t.i.d.) for 14 consecutive days. The efficacy and safety of BRH were evaluated. A total of 18 patients with moderate COVID-19 were randomized into the BRH group (n = 12) or the control group (n = 6). There were suggestions of BRH advantage over placebo in improved chest computed tomography, need for oxygen therapy, and discharge rate within 20 days. However, none of these findings were statistically significant. BRH tablets may potentially have a beneficial effect in patients with COVID-19, especially for those with lung or hepatic injury. A further definitive large-scale clinical trial is feasible and necessary.
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