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临床试验/NCT04336956
NCT04336956招募中不适用

Covid-19 Pediatric Observatory

Centre Hospitalier Intercommunal Creteil76 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2020年4月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
5,000
试验地点
76
主要终点
Percentage of children with severe or critical form.

研究概览

简要总结

In early December 2019, cases of pneumonia of unknown origin were reported in Wuhan, Hubei Province in the People's Republic of China. The disease spreads rapidly and the number of sick people is increasing. On January 3, 2020 a new virus of the coronavirus family is identified in samples of bronchoalveolar lavage fluid from a patient in Wuhan and subsequently confirmed as the cause of these pneumonias. On 7 January 2020, the World Health Organization (WHO) designated it as the new coronavirus 2019 (i.e. 2019-nCoV). On 11 February 2020, the WHO designated the disease associated with 2019-nCoV as coronavirus 2019 disease (COVID-19). On 12 March, WHO announced that the COVID-19 outbreak is a pandemic.

As of March 24, 2020, more than 375,000 cases of COVID-19 had been diagnosed with more than 16,000 deaths attributed to this virus. (Ref WHO https://www.who.int/emergencies/diseases/novel-coronavirus-2019 ).

In France, the number of cases rose from 105 cases at the end of February to 19615 confirmed cases on March 24. (Source Public Health France). Most of the cases are adults. However, children are not completely spared and serious cases have been described. These severe cases can be respiratory or extra-respiratory (e.g. myocarditis). We also know that pediatric and adult cases differ in terms of clinical, biological and imaging findings, particularly chest CT scans. However, the description of paediatric pictures, especially severe forms and the involvement of children suffering from co-morbidities, remains poorly reported. Finally, the risk factors for serious cases in children remain largely unknown.

This observatory aim to describe the clinical phenotypes of hospitalized pediatric patients with Covid19 in France, according to age groups. Moreover for a subgroup of patients, informations regarding the long covid will be reported.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
0 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children < 18 years old
  • Admitted in French pediatric wards
  • With a confirmed COVID-19 infection. ( on Nasal and pharyngeal swab specimens or blood samples tested positive for 2019-nCoV nucleic acid using real-time reverse-transcriptase polymerase-chain-reaction (RT- PCR) assay; or on typical chest CT signs

排除标准

  • Expressed refusal to participate

结局指标

主要结局

Percentage of children with severe or critical form.

时间窗: Day 14

次要结局

  • Percentage of children requiring intensive care support(at day 14)
  • CT chest of children(at admission)
  • Pulmonary echography(Day 14)
  • Clinical symptoms of children(day 14)
  • Evaluation of long covid(up to 12months)
  • Biological results of children(day 14)
  • nasopharynx SARScov2 PCR(at admission)
  • number of hospital days(up to 12months)
  • nasopharynx multiplex PCR(at admission)
  • nasopharynx sarscov2 load(at day 7)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (76)

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