Back to resultsEvaluating 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)
Primary Purpose
Novel Coronavirus Pneumonia, 2019-nCoV
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Bromhexine Hydrochloride Tablets
Arbidol Hydrochloride Granules
Recombinant Human Interferon α2b Spray
Sponsored by
About this trial
This is an interventional treatment trial for Novel Coronavirus Pneumonia
Eligibility Criteria
Inclusion Criteria:
- 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.
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.
Sites / Locations
- The Second AffIliated Hospital of Wenzhou Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
Treatment group
Control group
Outcomes
Primary Outcome Measures
Time to clinical recovery after treatment
Defined as random to fever, respiratory rate return to normal and cough remission over 48 hours.
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
Secondary Outcome Measures
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.
Dynamic changes of oxygenation index
oxygenation index
Time to cure
time of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery
rate to cure
proportion of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery among infected patients
Time to defervescence
defervescence is defined as below 37 Celcius degrees（ear temperature）
Time to cough remission
Time to dyspnea remission
Days of supplemental oxygenation
Rate of patients with requring supplemental oxygen
Rate of patients with mechanical ventilation
Time of negative COVID-19 nucleic acid results
Rate of negative COVID-19 nucleic acid results
Rate of ICU admission
28-day mortality
Full Information
NCT ID
NCT04273763
First Posted
February 14, 2020
Last Updated
April 29, 2020
Sponsor
Second Affiliated Hospital of Wenzhou Medical University
Collaborators
Wanbangde Pharmaceutical Group Co., LTD
1. Study Identification
Unique Protocol Identification Number
NCT04273763
Brief Title
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
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)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 16, 2020 (Actual)
Primary Completion Date
May 10, 2020 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Wenzhou Medical University
Collaborators
Wanbangde Pharmaceutical Group Co., LTD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Novel Coronavirus Pneumonia, 2019-nCoV
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Treatment group
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Control group
Intervention Type
Drug
Intervention Name(s)
Bromhexine Hydrochloride Tablets
Intervention Description
Bromhexine Hydrochloride Tablets
Intervention Type
Drug
Intervention Name(s)
Arbidol Hydrochloride Granules
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Recombinant Human Interferon α2b Spray
Intervention Description
Standard treatment refers to the latest edition of Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection.
Primary Outcome Measure Information:
Title
Time to clinical recovery after treatment
Description
Defined as random to fever, respiratory rate return to normal and cough remission over 48 hours.
Time Frame
within 14 days from the start of medication
Title
Rate of aggravation
Description
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 Frame
within 14 days from the start of medication
Secondary Outcome Measure Information:
Title
Clinical remission rate
Description
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.
Time Frame
within 14 days from the start of medication
Title
Dynamic changes of oxygenation index
Description
oxygenation index
Time Frame
within 14 days from the start of medication
Title
Time to cure
Description
time of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery
Time Frame
within 14 days from the start of medication
Title
rate to cure
Description
proportion of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery among infected patients
Time Frame
within 14 days from the start of medication
Title
Time to defervescence
Description
defervescence is defined as below 37 Celcius degrees（ear temperature）
Time Frame
within 14 days from the start of medication
Title
Time to cough remission
Time Frame
within 14 days from the start of medication
Title
Time to dyspnea remission
Time Frame
within 14 days from the start of medication
Title
Days of supplemental oxygenation
Time Frame
within 14 days from the start of medication
Title
Rate of patients with requring supplemental oxygen
Time Frame
within 14 days from the start of medication
Title
Rate of patients with mechanical ventilation
Time Frame
within 14 days from the start of medication
Title
Time of negative COVID-19 nucleic acid results
Time Frame
within 14 days from the start of medication
Title
Rate of negative COVID-19 nucleic acid results
Time Frame
within 14 days from the start of medication
Title
Rate of ICU admission
Time Frame
within 14 days from the start of medication
Title
28-day mortality
Time Frame
From the first day of screening to the day of follow-up (28 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
XIAN SHEN, phd
Organizational Affiliation
The 2nd Affiliated Hospital of Wenzhou Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
The Second AffIliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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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