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)

NCT04273763 | Unknown

• 1 other identifier: 2019NCP1.0
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Novel Coronavirus Pneumonia; 2019-nCoV

Outcome Measures

Primary Outcomes (2)

• Time to clinical recovery after treatment

  Defined as random to fever, respiratory rate return to normal and cough remission over 48 hours.

  within 14 days from the start of medication

• Rate of aggravation

  Aggravation was defined as(one of them): respiratory distress, RR ≥ 30 times / min; SpO2 ≤ 93% in resting state; arterial partial pressure of oxygen (PaO2) /concentration of oxygen (FiO2) ≤ 300mmHg

  within 14 days from the start of medication

Secondary Outcomes (14)

• Clinical remission rate

  within 14 days from the start of medication

• Dynamic changes of oxygenation index

  within 14 days from the start of medication

• Time to cure

  within 14 days from the start of medication

• rate to cure

  within 14 days from the start of medication

• Time to defervescence

  within 14 days from the start of medication

Study Arms (2)

Group A

EXPERIMENTAL

Treatment group

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

Group B

ACTIVE COMPARATOR

Control group

Drug: Arbidol Hydrochloride Granules; Drug: Recombinant Human Interferon α2b Spray

Interventions

Bromhexine Hydrochloride Tablets DRUG

Bromhexine Hydrochloride Tablets

Group A

Arbidol Hydrochloride Granules DRUG

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.

Group A; Group B

Recombinant Human Interferon α2b Spray DRUG

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

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 80 years (Including 18and 80years, male or female).
• One of them:
• Laboratory (RT-PCR) and clinical symptoms confirmed case of novel coronavirus pneumonia (COVID-19).
• Patients diagnosed clinically as suspected cases.
• Ability to communicate well with researchers and sign the informed consent Form (ICF) voluntarily.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead
• Wanbangde Pharmaceutical Group Co., LTD: collaborator

Study Sites (1)

The Second AffIliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Interventions

Bromhexine

Intervention Hierarchy (Ancestors)

Aniline Compounds; Amines; Organic Chemicals; Cyclohexylamines

Study Officials

• XIAN SHEN, phd

  The 2nd Affiliated Hospital of Wenzhou Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 18, 2020
• Study Start: February 16, 2020
• Primary Completion: May 10, 2020
• Study Completion: June 1, 2020
• Last Updated: May 1, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)