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

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

Study Overview

• Status: Unknown
• Conditions: 2019-nCoV

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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Kunling Shen, MD,PhD; Email: kunlingshen1717@163.com

Study Locations

• China
  • Beijing, China
    • Beijing Children's Hospital,
    • Contact: Lina Wang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 15, 2020
• Primary Completion (ANTICIPATED): December 31, 2020
• Study Completion (ANTICIPATED): December 31, 2020

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (ACTUAL): February 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 14, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Children; 2019-nCoV infection; 2019-nCoV pneumonia
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Infections
• Other Study ID Numbers: BCH Lung 012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No