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

Unknown status
2019-nCoV
Eligibility 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.

Exclusion Criteria:

Subject will be excluded if she or he has one of the following:

1. First diagnosis is not pneumonia.

2. Any one of the novel coronavirus laboratory test results show positive.

3. Children or their parents disagree to conduct this study.

Eligibility Gender
All
Eligibility Age
Minimum: 1 Day ~ Maximum: 18 Years
Countries
China
Locations

Beijing Children's Hospital,
Beijing, China

Investigator: Lina Wang

Contacts

Baoping Xu, MD,PhD
861059616308
xubaopingbch@163.com

Kunling Shen, MD,PhD
kunlingshen1717@163.com

Beijing Children's Hospital
NCT Number
Keywords
2019-nCoV infection
2019-nCoV pneumonia
Children
MeSH Terms
Infections
COVID-19