Epidemiological Study of the Spread of SARS-CoV-2 in the Household of a Person Who Has Had a COVID-19 Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Measure of the proportion of contact persons who have developed anti-SARS-CoV-2 antibodies (secondary transmission rate) within the same household of a subject who had a COVID-19 disease assessed by a rapid diagnostic-oriented test
研究概览
简要总结
Evaluating the rate of exposure to the virus in the close contact population who shared the home of a person infected with SARS-CoV-2 at the time of infection of the index case - adults or children - is a major factor in assessing the spread. virus in the family environment, assess the factors of circulation and determine whether immunity has been acquired. Screening for specific antibodies to SARS-CoV-2 will determine the exposure and protection acquired against this virus.
Knowing the intra-family secondary transmission rate is essential for supporting the strategies for lifting the confinement envisaged and implementing a personalized approach.
As of March 8, a platform for the home management of COVID + patients was set up when they, pauci or moderately symptomatic, do not require hospitalization. As of May 6, 2020, 881 patients have been registered in COVID and followed, constituting the active COVIDOM / PSL file. Of the 512 patients included between March 1 and 31, 45% have a household consisting of 3 people.
All patients had weekly clinical follow-up by telephone for the duration of the disease with a maximum of 4 weeks having been achieved.
If the recommendations of barrier gestures, isolation in an apartment were made during the symptomatic phase, the absence of masks available to all did not allow, in practice, to achieve the isolation and quarantine recommended ideally. to break the transmission of the virus.
The FAMI-CoV study proposes to assess the rate of exposure to the virus in contacts sharing the same focus of index cases. A sub-study will assess the proportion of antibodies that have been neutralizing.
详细描述
Transmission of the virus is possible from patients without or with very few symptoms. The viral load is high from the onset of symptoms and then decreases to the limit of detection on D21. The period of contagiousness would start 2.3 days before the symptoms (95% CI, 0.8-3.0 J) and would reach a peak at 0.7 J (95% CI, -0.2-2.0 J). This contagiousness would then decrease rapidly within 7 days with an estimated proportion of pre-symptomatic transmission of 44%.
The IgG and IgM antibodies generated by SARS-CoV-2 can be detected 1 to 3 weeks after exposure.
Guo et al studied the kinetics of IgM, IgA and IgG responses by an ELISA based on the SARS-CoV-2 core on 208 plasma from 82 confirmed cases and 58 probable cases of COVID-19. The antibodies are found from the first day after the onset of symptoms. The median time to detection of IgM and IgA was 5 days (IQR, 3-6), while IgG was detected 14 days (IQR, 10-18) after onset of symptoms, with a positive rate of 85, 4%, 92.7% and 77.9%, respectively. In confirmed and probable cases, the positive IgM antibody levels were 75.6% and 93.1%, respectively. The detection efficiency by IgM ELISA is superior to that of PCR after 5.5 days of onset of symptoms. The infection detection rate is increased (98.6%) by combining ELISA IgM test with PCR for each patient compared to a single qPCR test (51.9%). No cross-reactivity was found with common coronaviruses.
Zhao et al looked for total antibodies, IgM and IgG in 173 patients (median age, 48 years) with COVID-19 confirmed by PCR. The overall seroconversion rate, IgM and IgG, were 93%, 82.7% and 64.7%, respectively, with a median time to seroconversion around day 12. The presence of antibodies is less than 40% during the week following the onset of the disease to reach 100% (Ab), 94% (IgM) and 80% (IgG) by day 15.
In a study of 285 patients with COVID-19, 100% of patients developed specific antibodies within an average of 19 days after the onset of symptoms. The IgG and IgM antibody plateau is reached six days after seroconversion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult> 18 years old
- •Having presented a SARS-CoV-2 infection confirmed by PCR (INDEX COVID / PCR +)
- •or having presented clinical symptoms compatible with the diagnosis of COVID-19 (COVID-like) with at least 3 of the following symptoms for ⩾ 48 hours: fever, cough, anosmia, ageusia, headache, diarrhea, or CT scan with pneumopathy image in frosted glass
- •Living at the time of symptoms with at least 2 other people in the same household
- •Written consent for himself and for minors for whom he is responsible
- •Contact case
- •Adult (s) or child (ren), aged 3 to 17 (school age including kindergarten), living in the same household as the index case at the time of the symptoms of the index case
- •Written consent for adults
- •Consent given by parents for minors
排除标准
- •Patient protected by law (patient under guardianship and guardianship, person deprived of liberty)
- •Patient with major cognitive disorders.
结局指标
主要结局
Measure of the proportion of contact persons who have developed anti-SARS-CoV-2 antibodies (secondary transmission rate) within the same household of a subject who had a COVID-19 disease assessed by a rapid diagnostic-oriented test
时间窗: 4 hours
Measure of anti-SARS-CoV-2 antibodies using COVID-PRESTO (AAZ company)
次要结局
未报告次要终点