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| Name | Class |
|---|---|
| Wanbangde Pharmaceutical Group Co., LTD | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Treatment group |
|
| Group B | Active Comparator | Control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bromhexine Hydrochloride Tablets | Drug | Bromhexine Hydrochloride Tablets |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Aged between 18 and 80 years (Including 18and 80years, male or female).
One of them:
Ability to communicate well with researchers and sign the informed consent Form (ICF) voluntarily.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| XIAN SHEN, phd | Second Affiliated Hospital of Wenzhou Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second AffIliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | 325000 | China |
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| Arbidol Hydrochloride Granules |
| Drug |
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. |
|
| Recombinant Human Interferon α2b Spray | Drug | Standard treatment refers to the latest edition of Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection. |
|
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) |
| ID | Term |
|---|---|
| D001964 | Bromhexine |
| ID | Term |
|---|---|
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D003514 | Cyclohexylamines |
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