IRCT20200128046294N2已完成3 期
A prospective randomized controlled trial comparing Sovodak (Sofosbuvir plus Daclatasvir) in participants with moderate to severe Coronavirus disease (COVID-19) compared to standard of care treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
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
- •Both genders
- •Age =18 years at time of signing Informed Consent Form
- •Willing and able to provide written informed consent prior to performing study to any assigned treatment arm
- •Must agree not to enroll in another study of an investigational agent prior to completion of study
- •Will be admitted to Shariati hospital (Tehran), Baharloo (Tehran), Sina (Tehran), Sayyad Shirazi (Gorgan) and not transferred to another hospital
- •Laboratory (RT-PCR) confirmed infection with 2019-nCoV
- •Lung involvement confirmed with chest CT scan
- •Hospitalized patients with: Fever (Oral temperature = 37.8 ?) and at least one of Respiratory rate >24/min / O2Sat<94% or the Pa02/Fi02 ratio <300mgHg
- •=8 days since illness onset
排除标准
- •Known allergic reaction to Sofosbuvir or Daclatasvir
- •Pregnant or breastfeeding, or positive pregnancy test
- •Receipt of any experimental treatment for COVID-19 prior to the time of the screening evaluation
- •Heart rate < 60/min
- •Taking Amiodarone
- •Evidence of multiorgan failure
- •Requiring mechanical ventilation at screening
- •eGFR< 50 mL/min
研究者
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