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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)

Trial Profile

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)

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 04 May 2020

At a glance

  • Drugs Bromhexine (Primary) ; Interferon alpha-2b; Umifenovir
  • Indications COVID 2019 infections; Pneumonia
  • Focus Therapeutic Use
  • Most Recent Events

    • 29 Apr 2020 Planned End Date changed from 30 Apr 2020 to 1 Jun 2020.
    • 29 Apr 2020 Planned primary completion date changed from 15 Apr 2020 to 10 May 2020.
    • 29 Apr 2020 Status changed from recruiting to active, no longer recruiting.

Trial Overview

Purpose

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.

Primary Endpoints

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

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

Other Endpoints

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

Dynamic changes of oxygenation index

description: oxygenation index time_frame: within 14 days from the start of medication

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

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

Time to defervescence

description: defervescence is defined as below 37 Celcius degrees ear temperature time_frame: within 14 days from the start of medication

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) [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -
Pneumonia treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 60

    Actual: 18

  • Sex male & female
  • Age Group 18-80 years; adult; elderly

Patient Inclusion Criteria

- Aged between 18 and 80 years (Including 18 and 80 years, 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.

Patient 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.

Trial Details

Identifiers

Identifier Owner
NCT04273763 ClinicalTrials.gov: US National Institutes of Health
2019NCP1-0 -

Organisations

  • Affiliations WanBangDe Pharmaceutical Group Co., Ltd.

Trial Dates

  • Initiation Dates

    Planned : 15 Feb 2020

    Actual : 16 Feb 2020

  • Primary Completion Dates

    Planned : 10 May 2020

  • End Dates

    Planned : 01 Jun 2020

Other Details

  • Design open; prospective; randomised; sequential
  • Phase of Trial Phase II
  • Location China
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
BromhexinePrimary Drug Oral Tablet
Interferon alpha-2b
-
Spray
Umifenovir
-
Granules

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.)

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.)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
TING LI, phd
13587876896
liting1021@aliyun.com
show details
-
XIAN SHEN, phd The 2nd Affiliated Hospital of Wenzhou Medical University
-

Centres

Centre Name Location Trial Centre Country
-
-
-
Second Affiliated Hospital of Wenzhou Medical University
-
-
The 2nd Affiliated Hospital of Wenzhou Medical University
-
-
WanBangDe Pharmaceutical Group Co.,Ltd.
-
-

Trial History

Event Date Event Type Comment
04 May 2020 Other trial event Last checked against the ClinicalTrials.gov record. Updated 04 May 2020
29 Apr 2020 Completion date Planned End Date changed from 30 Apr 2020 to 1 Jun 2020. Updated 04 May 2020
29 Apr 2020 Other trial event Planned primary completion date changed from 15 Apr 2020 to 10 May 2020. Updated 04 May 2020
29 Apr 2020 Status change - active, no longer recruiting Status changed from recruiting to active, no longer recruiting. Updated 04 May 2020
21 Feb 2020 New trial record New trial record Updated 21 Feb 2020
18 Feb 2020 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 24 Feb 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
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