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)

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.

Study Overview

• Status: Unknown
• Conditions: Novel Coronavirus Pneumonia; 2019-nCoV
• Intervention / Treatment: Drug: Bromhexine Hydrochloride Tablets; Drug: Arbidol Hydrochloride Granules; Drug: Recombinant Human Interferon α2b Spray

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • The Second Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Treatment group	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.
Active Comparator: Group B; Control group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical remission rate	Clinical remission was defined as (one of them): sustained (more than 48 hours) alleviation of illness based on symptom (fever, cough, dyspnea, myalgia, diarrhea and so on) all being absent and no evidence for progression.	within 14 days from the start of medication
Dynamic changes of oxygenation index	oxygenation index	within 14 days from the start of medication
Time to cure	time of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery	within 14 days from the start of medication
rate to cure	proportion of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery among infected patients	within 14 days from the start of medication
Time to defervescence	defervescence is defined as below 37 Celcius degrees（ear temperature）	within 14 days from the start of medication
Time to cough remission		within 14 days from the start of medication
Time to dyspnea remission		within 14 days from the start of medication
Days of supplemental oxygenation		within 14 days from the start of medication
Rate of patients with requring supplemental oxygen		within 14 days from the start of medication
Rate of patients with mechanical ventilation		within 14 days from the start of medication
Time of negative COVID-19 nucleic acid results		within 14 days from the start of medication
Rate of negative COVID-19 nucleic acid results		within 14 days from the start of medication
Rate of ICU admission		within 14 days from the start of medication
28-day mortality		From the first day of screening to the day of follow-up (28 days)

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Wenzhou Medical University
• Collaborators: Wanbangde Pharmaceutical Group Co., LTD
• Investigators: Study Chair: XIAN SHEN, phd, The 2nd Affiliated Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2020
• Primary Completion (Anticipated): May 10, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: February 14, 2020
• First Submitted That Met QC Criteria: February 14, 2020
• First Posted (Actual): February 18, 2020

Study Record Updates

• Last Update Posted (Actual): May 1, 2020
• Last Update Submitted That Met QC Criteria: April 29, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Coronavirus Infections; Pneumonia; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Respiratory System Agents; Expectorants; Interferons; Bromhexine
• Other Study ID Numbers: 2019NCP1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No