Host-pathogen Interactions During Paediatric and Adult SARS-CoV-2 Infection (COVID-19)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 12
- 主要终点
- Initial biological profile of children with COVID-19 infection
研究概览
简要总结
The new Severe acute respiratory syndrome coronavirus (SARS-CoV-2) named coronavirus disease 2019 (COVID-19) is currently responsible for a pandemic spread of febrile respiratory infections, responsible for a veritable global health crisis.
In adults, several evolutionary patterns are observed: i) a/pauci-symptomatic forms; ii) severe forms immediately linked to rare extensive viral pneumonia; and iii) forms of moderate severity, some of which progress to secondary aggravation (Day 7-Day 10). Children can be affected, but are more rarely symptomatic and severe pediatric forms are exceptional.
Like some other coronaviruses (SARS-CoV and Middle East respiratory syndrome coronavirus (MERS-CoV)), these differences in clinical expression could be based on a variability in the immunological response, notably either via inhibition of the type I interferon (IFN-I) response, or on the contrary an immunological dysregulation responsible for a "cytokine storm" associated with the aggravation. Little is known about the impact of these innate immune response abnormalities on the adaptive response. In addition, certain genetic factors predisposing to a state of "hyper-fragility" and certain viral virulence factors could also be predictive of the clinical response.
In this context, the main hypothesis is that the virological analysis and the initial biological and immunological profiles are correlated with the initial clinical presentation of COVID-19 infection. In particular, children forms and pauci-symptomatic disease in adults may be linked to a more robust innate immune response, including better production of IFN-I.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from birth to <18 years old;
- •Weight> 3 kilogram (kg);
- •Infection with SARS-CoV-2 virus confirmed by RT-PCR on upper respiratory tract sample
- •No fever or respiratory symptoms;
- •Not requiring hospitalization (or hospitalization not related to a SARS-CoV-2 infection);
- •Consent signed by at least one parent / holder of parental authority and assent of the child (if applicable);
- •Beneficiary of a social security scheme
- •Age from birth to <18 years old;
- •Weight> 3kg;
- •Infection with the SARS-CoV-2 virus confirmed by RT-PCR on a upper or low respiratory tract sample or pneumonia with scanner suggesting SARS-CoV-2 infection;
- •Hospitalized in a pediatric intensive care unit or in a general pediatrics unit
- •Consent signed by at least one parent / holder of parental authority and assent of the child (if applicable);
- •Beneficiary of a social security scheme
- •Age from birth to <18 years old;
- •Weight> 3 kg;
- •Negative SARS-CoV-2 PCR on at least one respiratory sample, and other confirmed viral infection
- •Hospitalized in a pediatric intensive care unit or in a general pediatrics unit, for a respiratory reason;
- •Consent signed by at least one parent / holder of parental authority and assent of the child (if applicable);
- •Beneficiary of a social security scheme
排除标准
- •Patients with any other inherited or acquired immune deficiency that could compromise the immunological evaluation;
- •Other Suspected or proved infection
- •Pregnancy.
- •Patients with any other inherited or acquired immune deficiency that could compromise the immunological evaluation;
- •Pregnancy.
- •Patients with any other inherited or acquired immune deficiency that could compromise the immunological evaluation;
- •Infection with the SARS-CoV-2 virus known among the relatives
- •Pregnancy.
研究组 & 干预措施
Children group E1
Children with confirmed asymptomatic or pauci-symptomatic COVID infection will be recruited in pediatric emergency departments, among siblings of COVID-19+ pediatric patients or through the blood collection centers set up by the occupational health services. A single visit will be scheduled at the hospital (for clinical examination, biology, immunology, virology measurements) and a phone call performed at day 14.
干预措施: Blood sample (Biological)
Children group E1
Children with confirmed asymptomatic or pauci-symptomatic COVID infection will be recruited in pediatric emergency departments, among siblings of COVID-19+ pediatric patients or through the blood collection centers set up by the occupational health services. A single visit will be scheduled at the hospital (for clinical examination, biology, immunology, virology measurements) and a phone call performed at day 14.
干预措施: Low or upper respiratory tract sample (Biological)
Children group E1
Children with confirmed asymptomatic or pauci-symptomatic COVID infection will be recruited in pediatric emergency departments, among siblings of COVID-19+ pediatric patients or through the blood collection centers set up by the occupational health services. A single visit will be scheduled at the hospital (for clinical examination, biology, immunology, virology measurements) and a phone call performed at day 14.
干预措施: phone call (Other)
Children group E2
Children with confirmed COVID-19 infection requiring hospitalization will be recruited within participating centers (mostly in emergency and intensive care units). Data will be recorded (clinical examination, biology, immunology, virology measurements) during their hospital stay (day 0, day 7, in case of worsening) and a phone call performed at day 14 (or onsite visit if patient still hospitalized).
干预措施: Blood sample (Biological)
Children group E2
Children with confirmed COVID-19 infection requiring hospitalization will be recruited within participating centers (mostly in emergency and intensive care units). Data will be recorded (clinical examination, biology, immunology, virology measurements) during their hospital stay (day 0, day 7, in case of worsening) and a phone call performed at day 14 (or onsite visit if patient still hospitalized).
干预措施: Low or upper respiratory tract sample (Biological)
Children group E2
Children with confirmed COVID-19 infection requiring hospitalization will be recruited within participating centers (mostly in emergency and intensive care units). Data will be recorded (clinical examination, biology, immunology, virology measurements) during their hospital stay (day 0, day 7, in case of worsening) and a phone call performed at day 14 (or onsite visit if patient still hospitalized).
干预措施: Stool collection or fecal swab (Biological)
Children group E3
Children with confirmed non-COVID-19 viral infection requiring hospitalization will be recruited within participating centers (mostly in intensive care units). At inclusion, data will be recorded (clinical examination, biology, immunology, virology measurements) and a phone call performed at day 14.
干预措施: Blood sample (Biological)
Children group E3
Children with confirmed non-COVID-19 viral infection requiring hospitalization will be recruited within participating centers (mostly in intensive care units). At inclusion, data will be recorded (clinical examination, biology, immunology, virology measurements) and a phone call performed at day 14.
干预措施: Low or upper respiratory tract sample (Biological)
Children group E3
Children with confirmed non-COVID-19 viral infection requiring hospitalization will be recruited within participating centers (mostly in intensive care units). At inclusion, data will be recorded (clinical examination, biology, immunology, virology measurements) and a phone call performed at day 14.
干预措施: Stool collection or fecal swab (Biological)
Children group E3
Children with confirmed non-COVID-19 viral infection requiring hospitalization will be recruited within participating centers (mostly in intensive care units). At inclusion, data will be recorded (clinical examination, biology, immunology, virology measurements) and a phone call performed at day 14.
干预措施: phone call (Other)
结局指标
主要结局
Initial biological profile of children with COVID-19 infection
时间窗: Day 0
Describe the immune response (biological profile in blood samples) of children and adults with COVID-19 infection and correlate it with the initial clinical presentation measurement of the following parameters in blood at time of inclusion: white blood cell count, C-reactive protein, procalcitonin, hepatic and renal functions, ferritin, vitamin C and D, fibrinogen, prothrombin time test and partial thromboplastin time in order to correlate them with the initial clinical presentation.
Initial immunological profile of children with COVID-19 infection
时间窗: Day 0
measurement of the following parameters in blood at time of inclusion: interferon alpha and gamma, Tumor necrosis factor (TNF) alpha, interleukins 6 and 10, transcriptomic signature of interferon, lymphocyte phenotyping and monocyte Human Leukocyte Antigen - DR isotype (HLA-DR) expression in order to correlate them with the initial clinical presentation.
次要结局
- Evolution of the immunological profile of children with COVID-19(Within 21 days following inclusion)
- Nasopharyngeal swabs SARS-CoV-2 viral loads of children with COVID-19(Within 21 days following inclusion)
- titers in specific Immunoglobulin G (IgG) antibodies of children with COVID-19(Within 21 days following inclusion)
- Clinical worsening(Within 21 days following inclusion)
- titers in specific Immunoglobulin M (IgM) antibodies of children with COVID-19(Day 0)
- titers in specific Immunoglobulin G (IgM) antibodies of children with COVID-19(Within 21 days following inclusion)
- Nasopharyngeal swabs SARS-CoV-2 viral loads of children with COVID-19(Day 0)
- titers in specific Immunoglobulin G (IgG) antibodies of children with COVID-19(Day 0)