JPRN-jRCTs031190269已完成2 期
A multicenter, open-label, randomized controlled phase II study to evaluate the efficacy and safety of inhaled ciclesonide for asymptomatic and mild patients with COVID-19 - RACCO trial
Sugiyama Haruhito0 个研究点目标入组 90 人开始时间: 2020年3月27日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
研究概览
简要总结
We conducted a randomized clinical trial to determine the efficacy and safety of inhaled ciclesonide for COVID-19. In patients with mild COVID-19 disease, pneumonia on CT did not improve but rather worsened in the inhaled ciclesonide group compared to symptomatic treatment group. Safety was not different in the two groups, and there were no serious adverse events.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Patient who have given written consent to participate in the study
- •2) Age is over 20 years old, regardless of gender.
- •3) SARS-CoV-2 PCR positive
- •4) Patients who have no apparent pneumonia due to COVID-19 on plain chest radiographs
- •5) Patients who can be hospitalized during study drug administration (Including accommodation and medical treatment)
- •6) Patients who can inhale ciclesonide using inhalation assist device
排除标准
- •1) Patients with a history of hypersensitivity to Ciclesonide
- •2) Except for COVID-19, who have infectious disease or deep mycosis without an effective antibacterial agent
- •3) Patients using inhaled or oral steroids
- •4) Patients with fever of 37.5 degrees for 7 days
- •5) Patients co-administering treatments that may have therapeutic effects on COVID-19
- •6) Patients who are considered inappropriate for inclusion in the study by the investigator
研究者
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