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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)

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ClinicalTrials.gov Identifier: NCT04273763
Recruitment Status : Active, not recruiting
First Posted : February 18, 2020
Last Update Posted : May 1, 2020
Sponsor:
Collaborator:
Wanbangde Pharmaceutical Group Co., LTD
Information provided by (Responsible Party):
Second Affiliated Hospital of Wenzhou Medical University

Tracking Information
First Submitted Date  ICMJE February 14, 2020
First Posted Date  ICMJE February 18, 2020
Last Update Posted Date May 1, 2020
Actual Study Start Date  ICMJE February 16, 2020
Estimated Primary Completion Date May 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2020)
  • Time to clinical recovery after treatment [ Time Frame: within 14 days from the start of medication ]
    Defined as random to fever, respiratory rate return to normal and cough remission over 48 hours.
  • Rate of aggravation [ Time Frame: within 14 days from the start of medication ]
    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
Original Primary Outcome Measures  ICMJE
 (submitted: February 14, 2020)
  • Rate of aggravation [ Time Frame: within 14 days from the start of medication ]
    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
  • Time to clinical recovery after treatment [ Time Frame: within 14 days from the start of medication ]
    Defined as random to fever, respiratory rate return to normal and cough remission over 48 hours.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2020)
  • Clinical remission rate [ Time Frame: within 14 days from the start of medication ]
    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.
  • Dynamic changes of oxygenation index [ Time Frame: within 14 days from the start of medication ]
    oxygenation index
  • Time to cure [ Time Frame: within 14 days from the start of medication ]
    time of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery
  • rate to cure [ Time Frame: within 14 days from the start of medication ]
    proportion of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery among infected patients
  • Time to defervescence [ Time Frame: within 14 days from the start of medication ]
    defervescence is defined as below 37 Celcius degrees(ear temperature)
  • Time to cough remission [ Time Frame: within 14 days from the start of medication ]
  • Time to dyspnea remission [ Time Frame: within 14 days from the start of medication ]
  • Days of supplemental oxygenation [ Time Frame: within 14 days from the start of medication ]
  • Rate of patients with requring supplemental oxygen [ Time Frame: within 14 days from the start of medication ]
  • Rate of patients with mechanical ventilation [ Time Frame: within 14 days from the start of medication ]
  • Time of negative COVID-19 nucleic acid results [ Time Frame: within 14 days from the start of medication ]
  • Rate of negative COVID-19 nucleic acid results [ Time Frame: within 14 days from the start of medication ]
  • Rate of ICU admission [ Time Frame: within 14 days from the start of medication ]
  • 28-day mortality [ Time Frame: From the first day of screening to the day of follow-up (28 days) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2020)
  • Clinical remission rate [ Time Frame: within 14 days from the start of medication ]
    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.
  • Dynamic changes of oxygenation index [ Time Frame: within 14 days from the start of medication ]
    oxygenation index
  • Time to cure [ Time Frame: within 14 days from the start of medication ]
    time of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery
  • rate to cure [ Time Frame: within 14 days from the start of medication ]
    proportion of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery among infected patients
  • Time to defervescence [ Time Frame: within 14 days from the start of medication ]
    defervescence is defined as below 37.8 Celcius degrees(ear temperature)
  • Time to cough remission [ Time Frame: within 14 days from the start of medication ]
  • Time to dyspnea remission [ Time Frame: within 14 days from the start of medication ]
  • Days of supplemental oxygenation [ Time Frame: within 14 days from the start of medication ]
  • Rate of patients with requring supplemental oxygen [ Time Frame: within 14 days from the start of medication ]
  • Rate of patients with mechanical ventilation [ Time Frame: within 14 days from the start of medication ]
  • Time of negative COVID-19 nucleic acid results [ Time Frame: within 14 days from the start of medication ]
  • Rate of negative COVID-19 nucleic acid results [ Time Frame: within 14 days from the start of medication ]
  • Rate of ICU admission [ Time Frame: within 14 days from the start of medication ]
  • 28-day mortality [ Time Frame: From the first day of screening to the day of follow-up (28 days) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Novel Coronavirus Pneumonia
  • 2019-nCoV
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Group A
    Treatment group
    Interventions:
    • Drug: Bromhexine Hydrochloride Tablets
    • Drug: Arbidol Hydrochloride Granules
    • Drug: Recombinant Human Interferon α2b Spray
  • Active Comparator: Group B
    Control group
    Interventions:
    • Drug: Arbidol Hydrochloride Granules
    • Drug: Recombinant Human Interferon α2b Spray
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 29, 2020)
18
Original Estimated Enrollment  ICMJE
 (submitted: February 14, 2020)
60
Estimated Study Completion Date  ICMJE June 1, 2020
Estimated Primary Completion Date May 10, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04273763
Other Study ID Numbers  ICMJE 2019NCP1.0
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Second Affiliated Hospital of Wenzhou Medical University
Study Sponsor  ICMJE Second Affiliated Hospital of Wenzhou Medical University
Collaborators  ICMJE Wanbangde Pharmaceutical Group Co., LTD
Investigators  ICMJE
Study Chair: XIAN SHEN, phd The 2nd Affiliated Hospital of Wenzhou Medical University
PRS Account Second Affiliated Hospital of Wenzhou Medical University
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP