2019-nCoV
Conditions
Keywords
2019-nCoV infection, 2019-nCoV pneumonia, Children
Brief summary
The study is designed to clarify the clinical characteristics, risk factors and long-term prognosis of children with 2019-nCoV infection in China.
Detailed description
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.
Interventions
None listed
Sponsors
Capital Institute of Pediatrics, China
The First Affiliated Hospital of Anhui Medical University
China-Japan Friendship Hospital
The First Affiliated Hospital of Xiamen University
Guangzhou Women and Children's Medical Center
Shenzhen Children's Hospital
First Affiliated Hospital of Guangxi Medical University
The Affiliated Hospital Of Guizhou Medical University
Hainan People's Hospital
Children's Hospital of Hebei Province
Wuhan Women and Children's Medical Center
Changchun Children's Hospital
Children's Hospital of Nanjing Medical University
Jiangxi Province Children's Hospital
Shengjing Hospital
Shanxi Provincial Maternity and Children's Hospital
Xian Children's Hospital
Children's Hospital of Chongqing Medical University
Tianjin Children's Hospital
Tianjin Medical University Second Hospital
Kunming Children's Hospital
Second Affiliated Hospital of Wenzhou Medical University
Beijing Children's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 18 Years
Healthy volunteers
No
Inclusion criteria
1. For the 2019-nCoV infection group Inclusion Criteria: Diagnosed with 2019-nCoV infection (with direct laboratory evidence). 1. Respiratory or blood samples tested positive for novel coronavirus nucleic acid with RT-PCR. 2. Gene sequencing of respiratory or blood samples show highly homologous with known novel coronaviruses.
Exclusion criteria
Subjects will be excluded if the children or their parents disagree to conduct this study. 2. For the control group Inclusion Criteria: 1. Diagnosed with pneumonia, and excepted of novel coronavirus infection. 2. The hospitalization time is the same as that of novel coronavirus pneumonia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The cure rate of 2019-nCoV. | 6 months | Percentage |
| The improvement rate of 2019-nCoV. | 6 months | Percentage |
| The incidence of long-term adverse outcomes. | 6 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participant(s) need intensive care | 2 weeks | — |
| Number of participant(s) with acute respiratory distress syndrome | 2 weeks | — |
| Duration of fever | 2 weeks | Days |
| Number of participant(s) who died during the trial | 10 months | — |
| Number of participant(s) with extra-pulmonary complications, including shock, renal failure, multiple organ failure, hemophagocytosis syndrome, et al. | 2 weeks | — |
| Duration of respiratory symptoms | 2 weeks | Days |
| Duration of hospitalization | 2 weeks | Days |
Countries
China
Contacts
Primary ContactBaoping Xu, MD,PhD
Backup ContactKunling Shen, MD,PhD
Outcome results
None listed