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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment Phase
Novel Coronavirus Pneumonia 2019-nCoV Drug: Bromhexine Hydrochloride Tablets Drug: Arbidol Hydrochloride Granules Drug: Recombinant Human Interferon α2b Spray Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : February 16, 2020
Estimated Primary Completion Date : May 10, 2020
Estimated Study Completion Date : June 1, 2020


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.




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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.

  2. Dynamic changes of oxygenation index [ Time Frame: within 14 days from the start of medication ]
    oxygenation index

  3. 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

  4. 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

  5. Time to defervescence [ Time Frame: within 14 days from the start of medication ]
    defervescence is defined as below 37 Celcius degrees(ear temperature)

  6. Time to cough remission [ Time Frame: within 14 days from the start of medication ]
  7. Time to dyspnea remission [ Time Frame: within 14 days from the start of medication ]
  8. Days of supplemental oxygenation [ Time Frame: within 14 days from the start of medication ]
  9. Rate of patients with requring supplemental oxygen [ Time Frame: within 14 days from the start of medication ]
  10. Rate of patients with mechanical ventilation [ Time Frame: within 14 days from the start of medication ]
  11. Time of negative COVID-19 nucleic acid results [ Time Frame: within 14 days from the start of medication ]
  12. Rate of negative COVID-19 nucleic acid results [ Time Frame: within 14 days from the start of medication ]
  13. Rate of ICU admission [ Time Frame: within 14 days from the start of medication ]
  14. 28-day mortality [ Time Frame: From the first day of screening to the day of follow-up (28 days) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04273763


Locations
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China, Zhejiang
The Second AffIliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Sponsors and Collaborators
Second Affiliated Hospital of Wenzhou Medical University
Wanbangde Pharmaceutical Group Co., LTD
Investigators
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Study Chair: XIAN SHEN, phd The 2nd Affiliated Hospital of Wenzhou Medical University
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Responsible Party: Second Affiliated Hospital of Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT04273763    
Other Study ID Numbers: 2019NCP1.0
First Posted: February 18, 2020    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Interferons
Bromhexine
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents