A Trial of Ciclesonide to Assess The Antiviral Effect for Adults With Mild-to-moderate COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Rate of SARS-CoV-2 eradication at day 14 from study enrollment
研究概览
简要总结
According to In vitro studies, ciclesonide showed good antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Although some cases were reported for the clinical effectiveness of ciclesonide in the treatment of COVID-19, there is no clinical trial to evaluate the antiviral effect on the reduction of viral load in patients with COVID-19. In this study, we aimed to investigate whether ciclesonide inhalation could eradicate SARS-CoV-2 compared to standard supportive care in patients with mild COVID-19.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with mild COVID-19 (NEWS scoring system 0-4)
- •Patient within 7 days from symptom onset or Patient within 48 hous after laboratory diagnosis (SARS-CoV-2 RT-PCR)
排除标准
- •Hypoxia (SaO2 <95%)
- •Unable to take oral medication
- •Unable to use inhaler
- •Pregnancy or breast feeding
- •Immunocompromising conditions
- •Moderate/severe renal dysfunction : creatinine clearance (CCL) < 30 mL/min
- •Moderate/severe liver dysfunction: AST or ALT > 5 times upper normal limit
- •Asthma or chronic obstructive lung disease
研究组 & 干预措施
Ciclesonide
Ciclesonide 320ug oral inhalation q12h for 14 days
干预措施: Ciclesonide Metered Dose Inhaler [Alvesco] (Drug)
结局指标
主要结局
Rate of SARS-CoV-2 eradication at day 14 from study enrollment
时间窗: Hospital day 14
Viral load
次要结局
- Rate of SARS-CoV-2 eradication at day 7 from study enrollment(Hospital day 7)
- Time to clinical improvement (days)(Up to 28 days)
- Time to SARS-CoV-2 eradication (days)(Hospital day 1, 4, 7, 10, 14, 21)
- Viral load area-under-the-curve (AUC) reduction versus control(Hospital day 1, 4, 7, 10, 14, 21)
- Proportion of clinical failure(Up to 28 days)
研究者
Woo Joo Kim
Professor
Korea University Guro Hospital