Viral Excretion in Contact Subjects at High/Moderate Risk of Coronavirus 2019-nCoV Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 324
- 试验地点
- 32
- 主要终点
- Time to SARS-CoV-2 nasopharyngeal excretion, from the day of the first high/moderate risk contact to 12 days after the last high/moderate risk contact with a laboratory-confirmed SARS-CoV-2 case.
研究概览
简要总结
In December 2019, a pneumonia due to a novel coronavirus (SARS-CoV-2) emerged in the city of Wuhan, in China. In a few weeks, the number of confirmed cases of SARS-CoV-2 infection has dramatically increased, with almost 150'000 cases and more than 6'000 reported deaths on March, 16th 2020.
Little is known on the rate of human-to-human transmission of this new coronavirus SARS-CoV-2 in the community and within the hospital.
Depending on the country, contact subjects considered to be at high or moderate risk of SARS-CoV-2 are, either isolated at home for a period of time defined by the health authorities or, on the contrary, continue their professional activity on the condition that they adopt measures to prevent transmission to those around them. In most European countries, healthcare workers adopt this second option. In all cases, it is most often recommended that contact persons monitor their state of health and communicate it to the persons dedicated to this action.
Whether such subjects become spreaders of the virus is not known, nor is the proportion of viral spreader who will develop a symptomatic infection.
详细描述
Procedures added by the research:
Phone calls for collection of reported symptoms. Nasopharyngeal swabs for determination of the presence of SARS-CoV-2 detected by PCR.
Blood sampling for determination of the presence of SARS-CoV-2 IgM or IgG. Saliva or blood sampling for whole exome sequencing of the subject.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High/moderate risk contact with a laboratory-confirmed SARS-CoV-2 case;
- •Within the 14 days following the last contact with a laboratory-confirmed SARS-CoV-2 case;
- •Obtaining informed consent.
排除标准
- •Subject deprived of freedom
- •Subject under a legal protective measure
结局指标
主要结局
Time to SARS-CoV-2 nasopharyngeal excretion, from the day of the first high/moderate risk contact to 12 days after the last high/moderate risk contact with a laboratory-confirmed SARS-CoV-2 case.
时间窗: 12 days (+/-2)
PCR at day 0, day 3, day 5, day 7 and day 12 following the last high/moderate risk contact
次要结局
- Factors associated with the time to SARS-CoV-2 nasopharyngeal excretion(12 days (+/-2))
- Proportion of contact subjects with positive serology defined as the presence of SARS-CoV-2 IgM or IgG at day 30 (+/-7) following last contact(30 days (+/-7))
- The time (days) between the first positive SARS-CoV-2 serology and the first negative SARS-CoV-2 serology.(365 days (+/-30))
- Proportion of contact subjects with apparition of any symptom suggestive of SARS-CoV-2 infection(12 days (+/-2))
- Time to apparition of any symptom suggestive of SARS-CoV-2 from the day of the first high/moderate risk contact to 12 days after the last high/moderate risk contact with a laboratory-confirmed SARS-CoV-2 case.(12 days (+/-2))
- Host genetic variants(1 day)
- Factors associated with the time to apparition of any symptom suggestive of SARS-CoV-2 infection(12 days (+/-2))