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)

Sponsor
Second Affiliated Hospital of Wenzhou Medical University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04273763
Collaborator
Wanbangde Pharmaceutical Group Co., LTD (Industry)
18
1
2
3.5
5.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Bromhexine Hydrochloride Tablets
  • Drug: Arbidol Hydrochloride Granules
  • Drug: Recombinant Human Interferon α2b Spray
N/A

Study Design

Study Type:
Interventional
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 :
Feb 16, 2020
Anticipated Primary Completion Date :
May 10, 2020
Anticipated Study Completion Date :
Jun 1, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Time to clinical recovery after treatment [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 [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 [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 [within 14 days from the start of medication]

    oxygenation index

  3. Time to cure [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 [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 [within 14 days from the start of medication]

    defervescence is defined as below 37 Celcius degrees(ear temperature)

  6. Time to cough remission [within 14 days from the start of medication]

  7. Time to dyspnea remission [within 14 days from the start of medication]

  8. Days of supplemental oxygenation [within 14 days from the start of medication]

  9. Rate of patients with requring supplemental oxygen [within 14 days from the start of medication]

  10. Rate of patients with mechanical ventilation [within 14 days from the start of medication]

  11. Time of negative COVID-19 nucleic acid results [within 14 days from the start of medication]

  12. Rate of negative COVID-19 nucleic acid results [within 14 days from the start of medication]

  13. Rate of ICU admission [within 14 days from the start of medication]

  14. 28-day mortality [From the first day of screening to the day of follow-up (28 days)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

  • Study Chair: XIAN SHEN, phd, The 2nd Affiliated Hospital of Wenzhou Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital of Wenzhou Medical University
ClinicalTrials.gov Identifier:
NCT04273763
Other Study ID Numbers:
  • 2019NCP1.0
First Posted:
Feb 18, 2020
Last Update Posted:
May 1, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 1, 2020