PRODUCT LITERATURE

Bromhexine Hydrochloride Tablets for the Treatmentof Moderate COVID-19: An Open-Label RandomizedControlled Pilot Study

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This open-label randomized controlled pilot study aimed to test the study feasibility of bromhexine hydrochloride (BRH) tab-lets 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. Routinetreatment 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 andsafety of BRH were evaluated. A total of 18 patients with moderate COVID-19 were randomized into the BRH group (n = 12) orthe 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.The epidemic novel coronavirus disease 2019 (COVID-19)has now rapidly spread from China to around the world.1,2Among all infected patients, 80% of patients have beencategorized as having moderate disease; and the overallfatality rate is ~ 2.3%, with the elderly experiencing a higherrate. 3 Asymptomatic carriers are also contagious, whichcontributes to the growing epidemic status. There is anurgent need for effective treatment to not only relieve thesymptomatic patients but to curb viral transmission.The novel coronavirus mainly invades the human bodythrough angiotensin-converting enzyme 2/transmembraneprotease serine 2 (TMPRSS2). 4 Previous studies on severeacute respiratory syndrome, Middle East respiratory syn-drome, and other respiratory viruses have revealed thatTMPRSS2 participates in the process of host cell entry,maturation, and release of the virus, which enhance theviral infectivity.5–7 Therefore, inhibition of TMPRSS2 maybe a promising therapeutic approach for COVID-19. 4 The1Department of Anesthesia and Critical Care, The Second Affiliated Hospital and Yuying Children’s Hospital of Wenzhou Medical University, Wenzhou, Zhejiang,China; 2 Clinical Research Unit, The Second Affiliated Hospital and Yuying Children’s Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China; 3 Departmentof Emergency, The Second Affiliated Hospital and Yuying Children’s Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China; 4 Department of CriticalMedicine, The Second Affiliated Hospital and Yuying Children’s Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China; 5 Department of Endocrinology, TheSecond Affiliated Hospital and Yuying Children’s Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China; 6 Department of Pharmacy, The Second AffiliatedHospital and Yuying Children’s Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China; 7 Department of Gastrointestinal Surgery, The Second AffiliatedHospital and Yuying Children’s Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China. *Correspondence: Xian Shen (13968888872@126.com)Received: May 27, 2020; accepted: August 17, 2020. doi:10.1111/cts.12881Study HighlightsWHAT IS THE CURRENT KNOWLEDGE ON THE TOPIC?✔ Bromhexine hydrochloride (BRH) is capable of inhib-iting transmembrane protease serine 2 (TMPRSS2) andTMPRSS2-specific viral entry and is theoretically re-garded to be effective against severe acute respiratorysyndrome-coronavirus 2.WHAT QUESTION DID THIS STUDY ADDRESS?✔ This open-label randomized controlled pilot study eval-uated the study feasibility of BRH tablets for the treatmentof coronavirus disease 2019 (COVID-19) and to explore itsclinical efficacy and safety.WHAT DOES THIS STUDY ADD TO OUR KNOWLEDGE?✔ The study of BRH tablets for the treatment of COVID-19is feasible and necessary.HOW MIGHT THIS CHANGE CLINICAL PHARMACOL-OGY OR TRANSLATIONAL SCIENCE?✔ BRH tablets may potentially have a beneficial effectagainst COVID-19, especially for patients with lung andhepatic injury. A further large-scale clinical trial is war-ranted to confirm our findings.

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English

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NONE

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LITERATURE

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Subject(s)

Demucin
Bromhexine Hydrochloride

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Statement of Responsibility

Clin. Transl. Sci (2020) 13, 1096–1102

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