IRCT20151227025726N24已完成2 期
Evaluating the efficacy and safety of bromhexine in hospitalized COVID-19 patients
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
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
- •Age =18 years at time of signing Informed Consent Form
- •Laboratory (RT-PCR) confirmed infection with COVID-19
- •Lung involvement confirmed with chest imaging
- •Hospitalized with a SaO2/SPO2=94% on room air or PaO2/FiO2 ratio <300mgHg
- •=12 days since illness onset
- •Willingness of study participant to accept randomization to any assigned treatment arm
- •Must agree not to enroll in another study of an investigational agent prior to completion of Day 28 of study
排除标准
- •Physician makes a decision that trial involvement is not in patients' best interest, or any condition that does not allow the protocol to be followed safely
- •Severe liver disease (e.g. Child Pugh score = C, AST>5 times upper limit)
- •Pregnant or breastfeeding, or positive pregnancy test
- •Patients with known severe renal impairment (estimated glomerular filtration rate =30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis
- •Will be transferred to another hospital which is not the study site within 72 hours
- •Receipt of any experimental treatment for 2019-nCoV (off-label, or trial related) within the 30 days prior to the time of the screening evaluation
- •Allergic to the Bromhexine
研究者
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