Study of the Immunological and Virological Response of Patients Infected With SARS-CoV-2 and Presenting an Asymptomatic or Pauci-symptomatic Form
概览
- 阶段
- 不适用
- 干预措施
- Data collection
- 疾病 / 适应症
- Covid19
- 发起方
- Assistance Publique - Hôpitaux de Paris
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Interferon response
- 状态
- 已完成
- 最后更新
- 上个月
概览
简要总结
The purpose of this study is to describe the immunological and virological response of patients infected with CoV-2-SARS and presenting an asymptomatic or mildly symptomatic form, in particular the innate and adaptive response as well as the virological clearance kinetics.
The research hypothesis is that patients with an ambulatory form of SARS-CoV-2 infection, whether asymptomatic or mildly symptomatic, are able to mount an innate and adaptive immunological response capable of rapidly clearing the virus, in contrast to severe forms in which an early deficit of type 1 IFN response has been demonstrated, possibly responsible for a defect in the control of viral replication in the blood.
详细描述
A new coronavirus (SARS-CoV-2) was identified in December 2019 in the Wuhan region of China and is currently causing a global pandemic. The disease, named COVID-19, causes an influenza syndrome associated with respiratory signs, but there are also asymptomatic and pauci-symptomatic forms. Approximately 2 to 3% of patients, primarily patients with pre-existing chronic diseases and the elderly, develop a very severe form responsible for an acute respiratory distress syndrome (ARDS) that can lead to death. It has been shown that patients with a severe and critical form had an impaired type 1 interferon response, with decreased plasma levels of IFN-alpha2 in the most severe patients compared to hospitalized patients with a moderate form, and undetectable levels of IFN-beta. This lack of type 1 IFN response was associated with greater viral persistence in the blood and an exaggerated inflammatory response mediated primarily by the NF-kB pathway. Almost all studies published to date on immune system disruption during CoV-2-SARS infection included mainly hospitalized patients requiring oxygen therapy due to their severity, assessed at the time of clinical worsening. Thus, there is no or little data on immunological response profiles, particularly on type 1 IFN response but also on other aspects of the immunological response (adaptive cellular and humoral immunity), and its relationship with viral clearance kinetics during ambulatory forms of SARS-CoV-2 infection, whereas these forms represent more than 95% of the clinical forms. The asymptomatic and pauci-symptomatic forms managed on an outpatient basis represent the most common form of CoV-2-SARS infection, with a favourable outcome in almost all cases. A better description and understanding of the immunological profile, including type 1 IFN response and viral clearance kinetics in saliva, blood and feces, during asymptomatic and mild clinical forms will allow the identification of the major players in the immune response against SARS-CoV-2, and thus better define the responses that are lacking in severe patients.
研究者
入排标准
入选标准
- •Adult patients
- •Nasopharyngeal PCR positive for SARS-CoV-2 within 48 hours prior to inclusion in the study protocol, carried out in one of the participating outpatient screening centers
- •Symptomatic patients (nasopharyngeal screening positive due to suggestive symptoms) or asymptomatic (nasopharyngeal screening positive due to screening after contact with a positive subject)
- •Patients who have been informed and signed the consent
- •Pregnant and breastfeeding women who may be included in the study.
排除标准
- •Patients with criteria for hospitalization at the time of diagnosis (seriousness criteria, impossibility of staying at home)
- •Non-consent or inability to obtain consent,
- •Patient with dementia or not authorized, for psychiatric reasons or intellectual failure, to receive information on the protocol and to give informed consent,
- •Patient under guardianship / curatorship
研究组 & 干预措施
Asymptomatic
40 asymptomatic patients to COVID-19 infection
干预措施: Data collection
Symptomatic
40 symptomatic patients to COVID-19 infection
干预措施: Blood count
Symptomatic
40 symptomatic patients to COVID-19 infection
干预措施: Blood collection
Asymptomatic
40 asymptomatic patients to COVID-19 infection
干预措施: Blood count
Asymptomatic
40 asymptomatic patients to COVID-19 infection
干预措施: Blood collection
Asymptomatic
40 asymptomatic patients to COVID-19 infection
干预措施: Nasopharyngeal swab
Asymptomatic
40 asymptomatic patients to COVID-19 infection
干预措施: Saliva samples
Asymptomatic
40 asymptomatic patients to COVID-19 infection
干预措施: Faeces samples
Asymptomatic
40 asymptomatic patients to COVID-19 infection
干预措施: Genetic blood collection
Symptomatic
40 symptomatic patients to COVID-19 infection
干预措施: Nasopharyngeal swab
Symptomatic
40 symptomatic patients to COVID-19 infection
干预措施: Saliva samples
Symptomatic
40 symptomatic patients to COVID-19 infection
干预措施: Faeces samples
Symptomatic
40 symptomatic patients to COVID-19 infection
干预措施: Genetic blood collection
Symptomatic
40 symptomatic patients to COVID-19 infection
干预措施: Data collection
结局指标
主要结局
Interferon response
时间窗: Up to 90 days
Concentration of type I, type II and type III Interferon in peripheral blood
次要结局
- Immunology : proteins(Up to 90 days)
- Immunology : cytokines(Up to 90 days)
- Immunology : cell population(Up to 90 days)
- Immunology : pathways(Up to 90 days)
- Immunology : antibody response(Up to 90 days)
- Virology : Nasopharyngeal Viral clearance kinetics(Up to 90 days)
- Virology : Saliva Viral clearance kinetics(Up to 90 days)
- Virology : faeces viral clearance kinetics(Up to 90 days)
- Virology : peripheral blood viral clearance kinetics(Up to 90 days)
- Virology : sequencing(Up to 90 days)