2019-nCoV, Novel Coronavirus Pneumonia
Conditions
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.
Interventions
DRUGRecombinant Human Interferon α2b Spray
Standard treatment refers to the latest edition of Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection.
DRUGBromhexine Hydrochloride Tablets
Bromhexine Hydrochloride Tablets
DRUGArbidol 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.
Sponsors
Wanbangde Pharmaceutical Group Co., LTD
Second Affiliated Hospital of Wenzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Dynamic changes of oxygenation index | within 14 days from the start of medication | oxygenation index |
| Time to cure | within 14 days from the start of medication | time of Clinical recovery, negative COVID-19 nucleic acid results and CT recovery |
| 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 |
| Time to defervescence | within 14 days from the start of medication | defervescence is defined as below 37 Celcius degrees（ear temperature） |
| 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) | — |
Countries
China
Outcome results
None listed