A Multicenter Observational Study About the Clinical Characteristics and Long-term Prognosis of 2019-nCoV Infection in Children
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- The incidence of long-term adverse outcomes.
研究概览
简要总结
The study is designed to clarify the clinical characteristics, risk factors and long-term prognosis of children with 2019-nCoV infection in China.
详细描述
As of February 10th, 2020, more than 40,000 human have been confirmed infected with a novel coronavirus (2019-nCoV) in China, with at least 800 reported deaths. Additional cases have been confirmed in multiple countries, and some are reported in children. Patients with confirmed 2019-nCoV infection have reported respiratory illness with fever, cough, et al. Some are asymptomatic carriers. However, there are relatively few diagnosed cases of children, and the long-term prognosis is unknown. Therefore, a multicenter observational study is needed to better understand the clinical characteristics of 2019-nCoV infection in children.
This observational study will last from February to December 2020. The patients enrolled were diagnosed with 2019-nCoV infection or 2019-nCoV pneumonia by Beijing Children's Hospital and other members of Chinese National Clinical Research Center for Respiratory Diseases in 2019-2020. At the same time, children hospitalized with pneumonia other than 2019-nCoV pneumonia during the same period are classified as the control group by 3~5:1 matching for age and sex to the 2019-nCoV group. After guardians signing the informed consent forms, all the participants' clinical data, laboratory examination results, image data and also the follow-up information after six months of their treatment will be collected.
The trial will be completed in 10 months, with subjects recruited from the hospitals that in partnership with clinical research collaboration of National Clinical Research Center for Respiratory Diseases.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diagnosed with 2019-nCoV infection (with direct laboratory evidence).
- •Respiratory or blood samples tested positive for novel coronavirus nucleic acid with RT-PCR.
- •Gene sequencing of respiratory or blood samples show highly homologous with known novel coronaviruses.
排除标准
- •Subjects will be excluded if the children or their parents disagree to conduct this study.
- •For the control group
- •Inclusion Criteria:
- •Diagnosed with pneumonia, and excepted of novel coronavirus infection.
- •The hospitalization time is the same as that of novel coronavirus pneumonia.
- •Exclusion Criteria:
- •Subject will be excluded if she or he has one of the following:
- •First diagnosis is not pneumonia.
- •Any one of the novel coronavirus laboratory test results show positive.
- •Children or their parents disagree to conduct this study.
结局指标
主要结局
The incidence of long-term adverse outcomes.
时间窗: 6 months
The cure rate of 2019-nCoV.
时间窗: 6 months
Percentage
The improvement rate of 2019-nCoV.
时间窗: 6 months
Percentage
次要结局
- Number of participant(s) need intensive care(2 weeks)
- Number of participant(s) with acute respiratory distress syndrome(2 weeks)
- Number of participant(s) with extra-pulmonary complications, including shock, renal failure, multiple organ failure, hemophagocytosis syndrome, et al.(2 weeks)
- Duration of hospitalization(2 weeks)
- Number of participant(s) who died during the trial(10 months)
- Duration of fever(2 weeks)
- Duration of respiratory symptoms(2 weeks)
研究者
Kunling Shen
Director of National Clinical Research Center for Respiratory Diseases, China
Beijing Children's Hospital