IRCT20200818048444N1已完成3 期
Verification of the efficacy of Bromhexine-hydrochloride in treatment of patients with COVID19 disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 no limit(—)
- 性别
- All
入选标准
- •18 years and older, both sexes
- •Having home contact, unmasked contact with a patient with Covid-19 confirmed by RT-PCR or clinical evidence or radiography of pneumonia and acute respiratory distress syndrome (ARDS);
- •No clinical signs of Covid-19 (fever, cough, dyspnea, shortness of breath, sore throat, extreme tiredness, digestive problems);
- •No chronic respiratory problems or other illnesses that are mistaken for symptoms of COVID-19
排除标准
- •Involvement with any other ongoing studies.
- •Pregnant or breast feeding woman or with positive pregnancy test result for fetal safety
- •Severe liver disease as a strong confounding factor
- •Severe renal failure as a strong confounding factor
- •Refusal by attending physician for no clinical equipoise
- •Advanced active malignancy as a strong confounding factor
- •Patient in other clinical trials for COVID-19 within 30 days before/after ICF as a confounding factor/s
- •Other patient characteristics (not thought to be related to underlying COVID-19) that portend a very poor prognosis (e.g, severe liver failure, severe renal failure, and etc. May impact primary and other clinical endpoints- Known allergy to study drug or its ingredients related to renin-angiotensin system (RAS), or frequent and/or severe allergic reactions with multiple medications for patient protection purposes
- •Other uncontrolled disease, as judged by investigators that may influence study endpoint and other clinical outcome
研究者
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