A Randomized, Single-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Anti-COVID-19 Antibody SA58 Nasal Spray, Among Close Contact With COVID-19 People
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,900
- 试验地点
- 1
- 主要终点
- Incidence of symptomatic COVID-19 cases
研究概览
简要总结
This is a randomized, single-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of SA58 nasal spray in close contact with COVID-19 people.
详细描述
This study is a randomized, single-blind, placebo-controlled clinical trial in close contacts to COVID-19. The investigational drug was manufactured by Sinovac Life Sciences Co. , Ltd.The purpose of this study is to estimate the efficacy and safety of SA58 nasal spray in close contacts to COVID-19. A total of 2900 subjects were planned to be enrolled,including 2300 subjects who were non-continuous exposed to COVID-19 in group A,600 subjects who were continuous exposed to COVID-19 in group B. All subjects started medication on the day of enrollment. During the medication period, the subjects were given nasal spray once every 3 hours,about 5-6 times a day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •Subjects aged 18 years and above on the day of enrollment;
- •Had recent contact with an infected person, and the time of PCR sampling from a positive infected person, or the time of first contact with a positive infected person should not exceed 72 hours;
- •The subjects can understand and voluntarily sign the informed consent form;
排除标准
- •Previous history of severe allergy or sensitivity to inhalation allergens;
- •Women are breastfeeding, pregnant, or planning to become pregnant during the study period;
- •Participated in clinical trials of SARS-CoV-2 neutralizing antibody injections within 180 days prior to screening or clinical trials of other drugs within 4 weeks prior to screening;
- •Subjects unable to cooperate with nasal spray inhalation;
- •Body temperature at baseline (Day 0)>37.0℃;
- •Had a severe neurological disorder (epilepsy, convulsions or convulsions) or psychosis, and have a family history of psychosis;
- •The researchers determined that the subjects had a serious chronic medical condition that could interfere with the conduct or completion of the study;
- •According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
研究组 & 干预措施
Experimental Group A（ non-continuous exposure to COVID-19）
1725 participants who were non-continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day.
干预措施: SA58 Nasal Spray (Drug)
Control Group A（ non-continuous exposure to COVID-19）
575 participants who were non-continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day .
干预措施: Placebo (Drug)
Experimental Group B (continuous exposure to COVID-19)
400 participants who were continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day.
干预措施: SA58 Nasal Spray (Drug)
Control Group B(continuous exposure to COVID-19)
200 participants who were continuous exposure to COVID-19 received nasal spray every 3 hours,about 5-6 times/day.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of symptomatic COVID-19 cases
时间窗: Up to 30 days(during case surveillance period)
Incidence of symptomatic COVID-19 cases confirmed by RT-PCR during case surveillance period
次要结局
- The number of days of infection(Up to 30 days (during case surveillance period))
- Incidence of symptomatic COVID-19 cases confirmed by RT-PCR in subjects stratified by different Ct values at the time of diagnosis of primary cases(≤30, >30)(Up to 30 days (during case surveillance period))
- Incidence of symptomatic COVID-19 cases confirmed by RT-PCR in subjects stratified by actual dosing interval(Up to 30 days (during case surveillance period))
- The infection rate of asymptomatic COVID-19 infected people confirmed by RT-PCR(Up to 30 days (during case surveillance period))
- The incidence rate of symptomatic COVID-19 cases (mild, normal, severe and critical)(Up to 30 days (during case surveillance period))
- The peak Ct value(Up to 30 days (during case surveillance period))