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

2019-nCoV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04270383
• Other study ID #: BCH Lung 012
• Status: Not yet recruiting
• Start date: February 15, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2020
• Source: Beijing Children's Hospital
• Contact: Baoping Xu, MD,PhD
• Phone: 861059616308
• Email: xubaopingbch[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study is designed to clarify the clinical characteristics, risk factors and long-term prognosis of children with 2019-nCoV infection in China.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• 2019-nCoV
• Infection

Locations

Country	Name	City	State
China	Beijing Children's Hospital,	Beijing

Sponsors (23)

Lead Sponsor

Collaborator

Beijing Children's Hospital

Capital Institute of Pediatrics, China, Changchun Children's Hospital, Children's Hospital of Chongqing Medical University, Children's Hospital of Hebei Province, Children’s Hospital of Nanjing Medical University, China-Japan Friendship Hospital, First Affiliated Hospital of Guangxi Medical University, Guangzhou Women and Children's Medical Center, Hainan People's Hospital, Jiangxi Province Children's Hospital, Kunming Children's Hospital, Second Affiliated Hospital of Wenzhou Medical University, Shanxi Provincial Maternity and Children's Hospital, Shengjing Hospital, Shenzhen Children's Hospital, The Affiliated Hospital Of Guizhou Medical University, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Xiamen University, Tianjin Children's Hospital, Tianjin Medical University Second Hospital, Wuhan Women and Children's Medical Center, Xian Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The cure rate of 2019-nCoV.	Percentage	6 months
Primary	The improvement rate of 2019-nCoV.	Percentage	6 months
Primary	The incidence of long-term adverse outcomes.		6 months
Secondary	Duration of fever	Days	2 weeks
Secondary	Duration of respiratory symptoms	Days	2 weeks
Secondary	Duration of hospitalization	Days	2 weeks
Secondary	Number of participant(s) need intensive care		2 weeks
Secondary	Number of participant(s) with acute respiratory distress syndrome		2 weeks
Secondary	Number of participant(s) with extra-pulmonary complications, including shock, renal failure, multiple organ failure, hemophagocytosis syndrome, et al.		2 weeks
Secondary	Number of participant(s) who died during the trial		10 months