Li: Bromhexine Hydrochloride Tablets for the Treatment of Moderate COVID-19: An Open-Label Randomized Controlled Pilot Study

Bromhexine Hydrochloride Tablets for the Treatment of Moderate COVID-19: An Open-Label Randomized Controlled Pilot Study

Li et al., Clinical and Translational Science, doi:10.1111/cts.12881

Li et al., Bromhexine Hydrochloride Tablets for the Treatment of Moderate COVID-19: An Open-Label Randomized Controlled.., Clinical and Translational Science, doi:10.1111/cts.12881

Sep 2020 Source PDF

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Tiny RCT with 12 bromhexine and 6 control patients showing non-statistically significant improvements in chest CT, need for oxygen therapy, and discharge rate within 20 days. Authors recommend a larger scale trial.

Bromhexine may be less effective for omicron due to the entry process moving towards TMPRSS2-independent fusion.

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risk of no hospital discharge, 75.0% lower, RR 0.25, p = 0.11, treatment 2 of 12 (16.7%), control 4 of 6 (66.7%), NNT 2.0.

risk of oxygen therapy, 50.0% lower, RR 0.50, p = 0.57, treatment 2 of 12 (16.7%), control 2 of 6 (33.3%), NNT 6.0.

recovery time, 3.2% higher, relative time 1.03, treatment 12, control 6.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

Li et al., 3 Sep 2020, Randomized Controlled Trial, China, peer-reviewed, 10 authors.

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Bromhexine Hydrochloride Tablets for the Treatment of Moderate COVID‐19: An Open‐Label Randomized Controlled Pilot Study

Ting Li, Laifang Sun, Wenwu Zhang, Chanfan Zheng, Chenchen Jiang, Mingjing Chen, Di Chen, Zhijuan Dai, Shihui Bao, Xian Shen

Clinical and Translational Science, doi:10.1111/cts.12881

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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