Official Title
Evaluating the Efficacy and Safety of Bromhexine Hydrochloride Tablets Combined With Standard Treatment/ Standard Treatment in Patients With Suspected and Mild Novel Coronavirus Pneumonia (COVID-19)
Brief Summary

Compare the efficacy and safety of Bromhexine Hydrochloride Tablets combined with standard treatment/ standard treatment in patients with suspected and mild, or common novel coronavirus pneumonia (COVID-19). Random, open, group sequential design.

Unknown status
Novel Coronavirus Pneumonia
2019-nCoV

Drug: Bromhexine Hydrochloride Tablets

Bromhexine Hydrochloride Tablets

Drug: Arbidol Hydrochloride Granules

Standard treatment refers to the latest edition of Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection. Arbidol Hydrochloride Granules is recommended but not enforced to use.

Drug: Recombinant Human Interferon α2b Spray

Standard treatment refers to the latest edition of Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection.

Eligibility Criteria

Inclusion Criteria:

- Aged between 18 and 80 years (Including 18and 80years, male or female).

- One of them:

1. Laboratory (RT-PCR) and clinical symptoms confirmed case of novel coronavirus
pneumonia (COVID-19).

2. Patients diagnosed clinically as suspected cases.

- Ability to communicate well with researchers and sign the informed consent Form (ICF)
voluntarily.

Exclusion Criteria:

- ALT≥5 times of ULN, level of total bilirubin≥3 times of ULN, or Cr≥1.5 times of ULN.

- Patients with serious severe liver disease.

- Excluded who diagnosed as pneumonia patients with novel coronavirus infection of
severe type and critical type. 【Diagnostic criteria reference the official guideline
"Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial
Version 5) "】.

- Patients with previous history of severe gastrointestinal diseases such as gastric
ulcers and bleeding.

- Patients with lactose intolerance.

- Patients who are allergic to the components of this medicine (Major components:
Bromhexine Hydrochloride; excipient: starch, lactose, magnesium stearate).

- Positive serum pregnancy test result for women with childbearing potential at
screening or lactating women.

- Other circumstances that the researcher considers inappropriate to participate in this
study.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 80 Years
Countries
China
Locations

The Second AffIliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China

XIAN SHEN, phd, Study Chair
The 2nd Affiliated Hospital of Wenzhou Medical University

Wanbangde Pharmaceutical Group Co., LTD
NCT Number
MeSH Terms
Pneumonia
Coronavirus Infections
Interferons
Bromhexine