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

Overview

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

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2020

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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • The cure rate of 2019-nCoV.
    • Time Frame: 6 months
    • Percentage
  • The improvement rate of 2019-nCoV.
    • Time Frame: 6 months
    • Percentage
  • The incidence of long-term adverse outcomes.
    • Time Frame: 6 months

Secondary Measures

  • Duration of fever
    • Time Frame: 2 weeks
    • Days
  • Duration of respiratory symptoms
    • Time Frame: 2 weeks
    • Days
  • Duration of hospitalization
    • Time Frame: 2 weeks
    • Days
  • Number of participant(s) need intensive care
    • Time Frame: 2 weeks
  • Number of participant(s) with acute respiratory distress syndrome
    • Time Frame: 2 weeks
  • Number of participant(s) with extra-pulmonary complications, including shock, renal failure, multiple organ failure, hemophagocytosis syndrome, et al.
    • Time Frame: 2 weeks
  • Number of participant(s) who died during the trial
    • Time Frame: 10 months

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 1 Day

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Beijing Children’s Hospital
  • Collaborator
    • Capital Institute of Pediatrics, China
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kunling Shen, Director of National Clinical Research Center for Respiratory Diseases, China – Beijing Children’s Hospital
  • Overall Official(s)
    • Kunling Shen, MD,PhD, Principal Investigator, Beijing Children’s Hospital of Capital Medical University, China
    • Tianyou Wang, MD,PhD, Principal Investigator, Beijing Children’s Hospital of Capital Medical University, China
    • Baoping Xu, MD,PhD, Principal Investigator, Beijing Children’s Hospital of Capital Medical University, China
  • Overall Contact(s)
    • Baoping Xu, MD,PhD, 861059616308, xubaopingbch@163.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.