Clinical Characteristics and Long-term Prognosis of 2019-nCoV Infection in Children

Study Overview
=================
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.

Official Title
-----------------
A Multicenter Observational Study About the Clinical Characteristics and Long-term Prognosis of 2019-nCoV Infection in Children

Conditions
-----------------
2019-nCoV

Participation Criteria
=================
Eligibility Criteria
-----------------
For the 2019-nCoV infection group Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 2019-nCoV infection group<br>Children hospitalized with direct laboratory confirmed of novel coronavirus with or without pneumonia are classified as the 2019-nCoV infection group. | |
| Control group<br>Children hospitalized with pneumonia other than the novel coronavirus pneumonia during the same hospitalization period as 2019-nCoV infection group are classified as the control group. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cure rate of 2019-nCoV. | Percentage | 6 months | 
| The improvement rate of 2019-nCoV. | Percentage | 6 months | 
| The incidence of long-term adverse outcomes. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of fever | Days | 2 weeks | 
| Duration of respiratory symptoms | Days | 2 weeks | 
| Duration of hospitalization | Days | 2 weeks | 
| 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 | 
| Number of participant(s) who died during the trial |  | 10 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
2019-nCoV infection, 2019-nCoV pneumonia, Children