Clinical Characteristics and Long-term Prognosis of 2019-nCoV Infection in Children
A Multicenter Observational Study About the Clinical Characteristics and Long-term Prognosis of 2019-nCoV Infection in Children
1 other identifier
observational
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2020
CompletedStudy Start
First participant enrolled
February 15, 2020
CompletedFirst Posted
Study publicly available on registry
February 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedFebruary 17, 2020
February 1, 2020
11 months
February 11, 2020
February 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (7)
Duration of fever
2 weeks
Duration of respiratory symptoms
2 weeks
Duration of hospitalization
2 weeks
Number of participant(s) need intensive care
2 weeks
Number of participant(s) with acute respiratory distress syndrome
2 weeks
- +2 more secondary outcomes
Study Arms (2)
2019-nCoV infection group
Children hospitalized with direct laboratory confirmed of novel coronavirus with or without pneumonia are classified as the 2019-nCoV infection group.
Control group
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.
Eligibility Criteria
Patients who are aged 1day to 18 years, and diagnosed with 2019-nCoV infection/pneumonia or pneumonia other than novel coronavirus hospitalized in the same period in China.
You may qualify if:
- 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.
You may not qualify if:
- Subjects will be excluded if the children or their parents disagree to conduct this study.
- For the control group
- Diagnosed with pneumonia, and excepted of novel coronavirus infection.
- The hospitalization time is the same as that of novel coronavirus pneumonia.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing Children's Hospitallead
- Capital Institute of Pediatrics, Chinacollaborator
- The First Affiliated Hospital of Anhui Medical Universitycollaborator
- China-Japan Friendship Hospitalcollaborator
- The First Affiliated Hospital of Xiamen Universitycollaborator
- Guangzhou Women and Children's Medical Centercollaborator
- Shenzhen Children's Hospitalcollaborator
- First Affiliated Hospital of Guangxi Medical Universitycollaborator
- The Affiliated Hospital Of Guizhou Medical Universitycollaborator
- Hainan People's Hospitalcollaborator
- Children's Hospital of Hebei Provincecollaborator
- Wuhan Women and Children's Medical Centercollaborator
- Changchun Children's Hospitalcollaborator
- Children's Hospital of Nanjing Medical Universitycollaborator
- Jiangxi Province Children's Hospitalcollaborator
- Shengjing Hospitalcollaborator
- Shanxi Provincial Maternity and Children's Hospitalcollaborator
- Xian Children's Hospitalcollaborator
- Children's Hospital of Chongqing Medical Universitycollaborator
- Tianjin Children's Hospitalcollaborator
- Tianjin Medical University Second Hospitalcollaborator
- Kunming Children's Hospitalcollaborator
- Second Affiliated Hospital of Wenzhou Medical Universitycollaborator
Study Sites (1)
Beijing Children's Hospital,
Beijing, China
Biospecimen
Serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kunling Shen, MD,PhD
Beijing Children's Hospital of Capital Medical University, China
- PRINCIPAL INVESTIGATOR
Tianyou Wang, MD,PhD
Beijing Children's Hospital of Capital Medical University, China
- PRINCIPAL INVESTIGATOR
Baoping Xu, MD,PhD
Beijing Children's Hospital of Capital Medical University, China
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of National Clinical Research Center for Respiratory Diseases, China
Study Record Dates
First Submitted
February 11, 2020
First Posted
February 17, 2020
Study Start
February 15, 2020
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
February 17, 2020
Record last verified: 2020-02