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)
Latest Information Update: 08 Apr 2022
At a glance
- Drugs Bromhexine (Primary) ; Interferon alpha-2b; Umifenovir
- Indications COVID 2019 infections; COVID-19 pneumonia
- Focus Therapeutic Use
- 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.
Most Recent Events
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 | - |
| COVID-19 pneumonia | treatment | mild |
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
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Primary Completion Dates
Planned : 10 May 2020
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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 |
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|
Spray |
| Umifenovir |
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|
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
show details
liting1021@aliyun.com |
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|
|
| 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 |
-
|
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|
| The 2nd Affiliated Hospital of Wenzhou Medical University |
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|
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| WanBangDe Pharmaceutical Group Co.,Ltd. |
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|
-
|
Trial History
| Event Date | Event Type | Comment |
|---|---|---|
| 08 Apr 2022 | Other trial event | According to ClinicalTrials.gov, the recruitment status of this study is unknown because the information has not been verified recently (last verified Apr 2020). Updated 08 Apr 2022 |
| 08 Apr 2022 | Other trial event | Last checked against the ClinicalTrials.gov record. Updated 08 Apr 2022 |
| 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
-
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov
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