Study of the Kinetics of COVID-19 Antibodies for 24 Months in Patients With Confirmed SARS-CoV-2 Infection According to the Clinical Severity of the Infection.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 187
- 试验地点
- 2
- 主要终点
- Presence of specific anti-SARS-CoV-2 antibodies
研究概览
简要总结
The main objective of the study is to describe the temporal curve of COVID-19 IgG and neutralizing antibodies over 24 months in an identified population of patients who presented with SARS-CoV-2 virus infection. The secondary objectives are to characterize the kinetics of the antibodies according to the severity of the clinical presentation and patient's characteristics and to determine if the anti-SARS-CoV-2 antibodies retain their neutralizing capacity over time. A sub-study aims to describe the kinetic of neutralizing antibodies (in blood and nasal mucosa) after vaccination.
详细描述
Given the seriousness of the global health consequences of the COVID-19 pandemic and the difficulty of covering the world population with effective vaccination, several questions arise:
- Are the antibodies made by a patient neutralizing and do they protect the individual from further contamination?
- What is the persistence of the antibodies over time according to the clinical presentation, knowing that the very symptomatic forms have developed a much higher level of antibodies than the forms followed only on an outpatient basis and no less severe?
- What is the impact of vaccination (against wild-type virus and emerging variants) ? The investigators propose a single-center, observational study including 300 patients to answer the two questions, by selecting from the file of all the patients having had a positive RT-PCR 3 distinct groups: severe (hospitalized), pauci-symptomatic to moderate (followed in ambulatory only). Note: people living with HIV can be included in each of the groups.
MAIN EVALUATION
> Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at M24 at each of the sampling times (M0, M3, M6, M9, M12, M15, M18, M24)
SECONDARY EVALUATION CRITERIA
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- 否
入选标准
- •Age > 18
- •Having had a confirmed infection with CoV-2-SARS by RT-PCR and/or serology (IgM and/or IgG specific as significant)
- •Being vaccinated against anti-SARS-CoV-2 (vaccine sub-study)
- •Benefiting from a Social Security system
- •Having consented to participate in the study
- •Accepting regular follow-up for 24 months
排除标准
- •Protected person (under guardianship or trusteeship)
- •Person under the protection of justice
- •Person unable to express consent
结局指标
主要结局
Presence of specific anti-SARS-CoV-2 antibodies
时间窗: Month 24
Presence of specific anti-SARS-CoV-2 antibodies in the different study groups at each sampling time
次要结局
- Presence of specific anti-SARS-CoV-2 antibodies in subgroups(Month 24)
- Measurement of activated CD4 in culture(Month 24)
- Presence of specific anti-SARS-CoV-2 antibodies(Month 12)
- Neutralizing capacity of anti-SARS-CoV-2 antibodies(Month 24)
- Measurement of activated CD8 (CD38+DR+) in culture(Month 24)
- Measurement of activated B lymphocytes in culture(Month 24)