Seroprevalence of SARS-CoV-2 Infection in Patients With HIV Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,200
- 试验地点
- 1
- 主要终点
- Measure of seroprevalence of COVID-19 infection assessed by the level of anti-Covid-19 IgG antibodies in the population of people living with HIV monitored at the Pitié-Salpêtrière hospital
研究概览
简要总结
As of May 26, 2020, 5,508,904 confirmed cases (145,279 in France) of COVID-19 and 346,508 deaths (28,457 in France) have been reported since December 8, 2019 worldwide. The rapid increase in the number of cases in our territory caused France to pass to level 3 of the epidemic on March 14, 2020.
The natural history of this disease is still poorly understood, particularly in patients infected with HIV, patients considered to be at higher risk for severe forms.
Knowing the seroprevalence in the population of people living with HIV will make it possible to better understand the Covid infection in immunocompromised patients, know the percentage of immunization and the persistence or not of the antibodies over time, specify the protective nature or not of these antibodies detected.
详细描述
To date, very little data is available in HIV-infected patients with Sars-Cov-2 infection. Only 11 cases of HIV patients with confirmed Sars-Cov-2 infection have been described in the literature. These patients are under 50 years of age, HIV infection with a controlled viral load in 8/11, 2 patients with a severe course requiring administration of tociluzumab, including one patient who died. In addition, the management of these HIV patients is not codified. Some authors have changed antiretroviral therapy to a protease inhibitor such as lopinavir or darunavir because of encouraging results in vitro but debated in patients. This clearly illustrates the disparity of approaches and the lack of data in this patient population.
Knowing the seroprevalence in the population of people living with HIV will allow us to better understand the Covid-19 infection in immunocompromised patients, know the percentage of immunization and the persistence or not of the antibodies over time as well as their unknown neutralizing effect. until now. No data exist on seroprevalence in the HIV population.
Serological tests can detect the immune response to COVID-19 in serum. Studies to date have shown seroconversion typically within two weeks of symptom onset, with notable differences depending on the studies, techniques and epitopes of the antigens chosen to detect the antibodies. A study which showed that the seropositivity rate reached 50% on the 11th day and 100% on the 39th day with a seroconversion time of 11, 12 and 14 days in median for the total antibodies, IgM and IgG.
Diagnosis of SARS-CoV-2 infection is a major public health issue. Serological tests are currently being developed. Enzyme-linked immunosorbent assay, performed on blood samples, can be performed in an automated manner and provide an estimate of the level of circulating antibody.
These serological tests could identify patients who have developed immunity to SARS-CoV-2 and be useful in the collection of epidemiological data related to COVID-19 or to know the serological status of exposed persons.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 18 years
- •HIV + patient followed at the Pitié-Salpêtrière hospital
- •Known HIV infection
- •Having been informed about the study and having given oral consent (no opposition)
- •Beneficiary or entitled to a social security scheme
排除标准
- •Refusal of participation by the patient
- •Patient subject to a legal protection measure
结局指标
主要结局
Measure of seroprevalence of COVID-19 infection assessed by the level of anti-Covid-19 IgG antibodies in the population of people living with HIV monitored at the Pitié-Salpêtrière hospital
时间窗: 12 months
Measure of anti-SARS-CoV-2 antibodies using Abbott system
次要结局
未报告次要终点