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)

Second Affiliated Hospital of Wenzhou Medical University

Status: Unknown

Conditions: 2019-nCoV; Novel Coronavirus Pneumonia

Treatments: Drug: Recombinant Human Interferon α2b Spray; Drug: Arbidol Hydrochloride Granules; Drug: Bromhexine Hydrochloride Tablets

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04273763

2019NCP1.0

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Group A

Experimental group

Description:

Treatment group

Treatment:

Drug: Bromhexine Hydrochloride Tablets

Drug: Arbidol Hydrochloride Granules

Drug: Recombinant Human Interferon α2b Spray

Group B

Active Comparator group

Description:

Control group

Treatment:

Drug: Arbidol Hydrochloride Granules

Drug: Recombinant Human Interferon α2b Spray