Safety and Effectiveness of SA58 Nasal Spray Against COVID-19 Infection in Medical Personnel：An Open-label, Blank-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 7,000
- 试验地点
- 1
- 主要终点
- COVID-19 infection rates
研究概览
简要总结
This is an open, blank controlled clinical trial to evaluate the efficacy and safety of SA58 nasal spray in the prevention COVID-19 infection among health care workers at high risk of SARS-CoV-2 infection.
详细描述
This is an open, blank controlled clinical trial to evaluate the efficacy and safety of SA58 nasal spray in the prevention COVID-19 infection among health care workers at high risk of SARS-CoV-2 infection.The investigational drug was manufactured by Sinovac Life Sciences Co. , Ltd.A total of 7000 medical personnel will be involved in this study: 3500 will use SA58 Nasal Spray in the drug group, and 3500 not use SA58 Nasal Spray in the blank control group. The medication is self-administered intranasally 1~2 times per day with an interval of 6 hours for about 30 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medical staff working in the designated COVID-19 hospitals and Fangcang shelter hospitals (alternate care sites) of COVID-19 cases in Hohhot;
- •Subjects were 18 years of age and older and in good health;
- •Subjects volunteered to use COVID-19 neutralizing antibody nasal spray.
排除标准
- •Previous history of severe allergies or sensitivity to inhaled allergens;
- •Women were pregnant or breastfeeding;
- •Subjects were unable to cooperate with nasal spray inhalation;
- •Other conditions for which medication was not appropriate.
研究组 & 干预措施
Drug group
3500 participants will use SA58 Nasal Spray in drug group.
干预措施: SA58 Nasal Spray (Drug)
结局指标
主要结局
COVID-19 infection rates
时间窗: Up to 30 days(during case surveillance period)
COVID-19 infection rates confirmed by RT-PCR among health care workers during the study period.
次要结局
- Infection rates of asymptomatic and symptomatic COVID-19 patients(Up to 30 days(during case surveillance period))
- Incidence of mild, normal, severe, and critical COVID-19 cases(Up to 30 days(during case surveillance period))
- The peak Ct value(Up to 30 days(during case surveillance period))
- Differences in the number of days of negative RT-PCR(Up to 30 days(during case surveillance period))