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)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Time to clinical recovery after treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Group A
Treatment group
干预措施: Bromhexine Hydrochloride Tablets (Drug)
Group A
Treatment group
干预措施: Arbidol Hydrochloride Granules (Drug)
Group A
Treatment group
干预措施: Recombinant Human Interferon α2b Spray (Drug)
Group B
Control group
干预措施: Arbidol Hydrochloride Granules (Drug)
Group B
Control group
干预措施: Recombinant Human Interferon α2b Spray (Drug)
结局指标
主要结局
Time to clinical recovery after treatment
时间窗: 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
时间窗: 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
次要结局
- Clinical remission rate(within 14 days from the start of medication)
- Dynamic changes of oxygenation index(within 14 days from the start of medication)
- Time to cure(within 14 days from the start of medication)
- rate to cure(within 14 days from the start of medication)
- Time to defervescence(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))