A Clinical Study to Assess Preliminary Efficacy, Safety and Tolerability of HH-120 Nasal Spray in Participants Diagnosed With Asymptomatic or Mild COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Time to achieving SARS-CoV-2 clearance (defined as negative quantitative Real-Time polymerase chain reaction [qRT-PCR] tests taken on two consecutive days).
研究概览
简要总结
To evaluate the preliminary efficacy and safety of HH-120 nasal spray in the treatment of asymptomatic or mild COVID-19.
详细描述
During this study, participants will receive HH-120 nasal spray treatment for 6 consecutive days, the efficacy and safety of HH-120 will be assessed throughout the study period based on viral clearance, clinical recovery, illness severity and adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 65 years old.
- •Participants with mild COVID-19 with symptom onset≤5 days or asymptomatic COVID-
- •Participants being able and willing to provide informed consent prior to any study-specific procedure.
排除标准
- •Participants with moderate or severe COVID-
- •Participants within the pregnancy or breastfeeding period or plan to be pregnant during the study period.
- •Participants requiring oxygen treatment (such as non-invasive ventilation, invasive mechanical ventilation, ECMO, etc.).
- •Participants with nasal disease that is inconvenient or intolerant of nasal spray administration, or cannot use the nasal spray treatment.
- •Participants with comorbid Malignancy or with a history of malignancy.
- •Participants with active or uncontrolled systemic autoimmune disease.
- •Insufficient function of key organs.
- •Other reasons considered by the investigator to be unsuitable for the trial.
研究组 & 干预措施
HH-120 group
HH-120 Nasal Spray
干预措施: HH-120 Nasal Spray (Biological)
结局指标
主要结局
Time to achieving SARS-CoV-2 clearance (defined as negative quantitative Real-Time polymerase chain reaction [qRT-PCR] tests taken on two consecutive days).
时间窗: Up to 12 days
Median time from first dose to achieving SARS-COV-2 clearance.
Proportion of participants with SARS-CoV-2 clearance.
时间窗: Up to 12 days
Proportion of participants achieving SARS-CoV-2 clearance from the first dose until Day 12.
次要结局
- Clinical recovery of COVID-19.(Up to 12 days)
- Viral load.(Up to 12 days)
- Adverse event.(Up to 12 days)
研究者
Ronghua Jin
Chief Physician
Beijing Ditan Hospital