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 Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Novel Coronavirus Pneumonia, 2019-nCoV

Intervention / Treatment
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* Drug: Bromhexine Hydrochloride Tablets
* Drug: Arbidol Hydrochloride Granules
* Drug: Recombinant Human Interferon α2b Spray


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Treatment group | Drug: Bromhexine Hydrochloride Tablets<br>* Bromhexine Hydrochloride Tablets<br>Drug: Arbidol Hydrochloride Granules<br>* 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.<br>Drug: Recombinant Human Interferon α2b Spray<br>* Standard treatment refers to the latest edition of Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection.<br>|
| Active Comparator: Group B<br>Control group | Drug: Arbidol Hydrochloride Granules<br>* 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.<br>Drug: Recombinant Human Interferon α2b Spray<br>* Standard treatment refers to the latest edition of Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to clinical recovery after treatment | Defined as random to fever, respiratory rate return to normal and cough remission over 48 hours. | within 14 days from the start of medication | 
| 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 | within 14 days from the start of medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | within 14 days from the start of medication | 
| Dynamic changes of oxygenation index | oxygenation index | within 14 days from the start of medication | 
| Time to cure | time of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery | within 14 days from the start of medication | 
| rate to cure | proportion of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery among infected patients | within 14 days from the start of medication | 
| Time to defervescence | defervescence is defined as below 37 Celcius degrees（ear temperature） | within 14 days from the start of medication | 
| Time to cough remission |  | within 14 days from the start of medication | 
| Time to dyspnea remission |  | within 14 days from the start of medication | 
| Days of supplemental oxygenation |  | within 14 days from the start of medication | 
| Rate of patients with requring supplemental oxygen |  | within 14 days from the start of medication | 
| Rate of patients with mechanical ventilation |  | within 14 days from the start of medication | 
| Time of negative COVID-19 nucleic acid results |  | within 14 days from the start of medication | 
| Rate of negative COVID-19 nucleic acid results |  | within 14 days from the start of medication | 
| Rate of ICU admission |  | within 14 days from the start of medication | 
| 28-day mortality |  | From the first day of screening to the day of follow-up (28 days) |