Use of Bromhexine and Hydroxychloroquine for Treatment of COVID-19 Pneumonia
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Duration of hospitalization
研究概览
简要总结
In the current situation it is of great importance to discover a safe, cost-effective and available treatment strategy in order to limit the rapidly spreading SARS-Cov-2. Recent studies have shown that hydroxychloroquine could have a role in the treatment of infected patients. It is however not very likely that hydroxychloroquine alone could be adequate for treatment of Covid-19 disease. Effective therapy that prevents the virus entrance should contain at least TMPRSS2 inhibitor or a competitive inhibitor of viral ACE 2 binding. The use of bromhexine at the dose adequate to selectively inhibit the TMPRSS2, resulting in preventing of viral entrance via TMPRSS2-specific pathway, coud be an effective treatment of Covid-19. In our study we would like to explore the therapeutic potential of bromhexin and hydroxychloroquine in Covid-19 patients.
Hypothesis
- Combined treatment with bromhexin and hydroxychloroquine shortens the course of disease in hospitalized Covid-19 patients compared to hydroxychloroquine alone.
- Combined treatment with bromhexin and hydroxychloroquine lowers the incidence of secundary pulmonary infections in hospitalized Covid-19 patients compared to hydroxychloroquine alone.
- Combined treatment with bromhexin and hydroxychloroquine decreases the need for ICU admission in hospitalized Covid-19 patients compared to hydroxychloroquine alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 years,
- •confirmed infection (positive PCR from nasopharyngeal swab),
- •fullfilled hospital admission criteria
排除标准
- •pregnancy,
- •known allergy for bromhexine or hydroxychloroquine,
- •epilepsy,
- •prolonged QTc interval,
- •Child C liver disease,
- •dementia,
- •psychoorganic syndrome,
- •terminal chronic disease
研究组 & 干预措施
hydroxychloroquine and bromhexine
Bromhexine 16 mg TID + hydroxychloroquine 200 mg BID
干预措施: Bromhexine Oral Tablet and/or hydroxychloroquine tablet (Drug)
hydroxychloroquine alone
hydroxychloroquine 200 mg BID
干预措施: Bromhexine Oral Tablet and/or hydroxychloroquine tablet (Drug)
结局指标
主要结局
Duration of hospitalization
时间窗: through study completion, an average of 6 months
number of days the patient is treated in the hospital
Duration of disease
时间窗: through study completion, an average of 6 months
Number of days from the onset of symptoms to hospital discharge
次要结局
- ICU stay duration(through study completion, an average of 6 months)
- Hospital-aquired pneumonia(through study completion, an average of 6 months)
- Oxygene therapy duration(through study completion, an average of 6 months)
- Mechanical ventilatory support duration(through study completion, an average of 6 months)