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)

• Status: Active, not recruiting
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University
• Collaborators: Wanbangde Pharmaceutical Group Co., LTD; WanBangDe Pharmaceutical Group Co.,Ltd.
• Treatments: Bromhexine; Interferons

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.