A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel, Phase 2 Study to Evaluate the Efficacy and Safety of UI030 in COVID-19 Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 140
- 主要终点
- Time to Clinical Improvement on World Health Organization (WHO) Ordinal Scale
研究概览
简要总结
This is a multi-center, randomized, double-blind, placebo-controlled, parallel, phase 2 study to evaluate the efficacy and safety of UI030 in COVID-19 patients
详细描述
Patients with moderate and severe COVID-19 were randomly assigned (1:1) to receive either UI030 (Budesonide/Arformoterol dry powder inhaler, 2 inhalations b.i.d) or placebo for 2 weeks.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult, aged 19 years or above
- •New onset of symptoms suggestive of COVID-19 (fever, cough, soar throat, etc) or diagnosed with COVID-19 within 7 days of participant being seen at visit 1
- •In the Investigator's opinion, is able and willing to comply with all trial requirements
排除标准
- •A condition requiring invasive oxygen support;
- •History of hypersensitivity to budesonide and arformoterol
- •Pregnancy, Breast-feeding
- •Participation in other clinical studies within 4 weeks prior to enrollment in this study.
- •Refusal of the patient to continue participating in the study/withdrawal of informed consent by the patient.
研究组 & 干预措施
UI030
UI030 (Budesonide/Arformoterol dry powder inhaler, 3 inhalations b.i.d at 3 days and 2 inhalations b.i.d at 11 days) or placebo for 2 weeks.
干预措施: UI030 (Drug)
Placebo
UI030 (Budesonide/Arformoterol dry powder inhaler, 3 inhalations b.i.d at 3 days and 2 inhalations b.i.d at 11 days) or placebo for 2 weeks.
干预措施: UI030 (Drug)
结局指标
主要结局
Time to Clinical Improvement on World Health Organization (WHO) Ordinal Scale
时间窗: 28 days
The median time to reach the clinical improvement on the WHO Ordinal 9 Scale for Clinical Improvement \[0-8\]
次要结局
- World Health Organization (WHO) Ordinal Scale for Clinical Improvement(28 days)
- World Health Organization (WHO) Ordinal Scale change(28 days)
- Clinical cure rate(28 days)