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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04270383
Recruitment Status : Not yet recruiting
First Posted : February 17, 2020
Last Update Posted : February 17, 2020
Sponsor:
Collaborators:
Capital Institute of Pediatrics, China
The First Affiliated Hospital of Anhui Medical University
China-Japan Friendship Hospital
The First Affiliated Hospital of Xiamen University
Guangzhou Women and Children's Medical Center
Shenzhen Children's Hospital
First Affiliated Hospital of Guangxi Medical University
The Affiliated Hospital Of Guizhou Medical University
Hainan People's Hospital
Children's Hospital of Hebei Province
Wuhan Women and Children's Medical Center
Changchun Children's Hospital
Children’s Hospital of Nanjing Medical University
Jiangxi Province Children's Hospital
Shengjing Hospital
Shanxi Provincial Maternity and Children's Hospital
Xian Children's Hospital
Children's Hospital of Chongqing Medical University
Tianjin Children's Hospital
Tianjin Medical University Second Hospital
Kunming Children's Hospital
Second Affiliated Hospital of Wenzhou Medical University
Information provided by (Responsible Party):
Kunling Shen, Beijing Children's Hospital

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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter Observational Study About the Clinical Characteristics and Long-term Prognosis of 2019-nCoV Infection in Children
Estimated Study Start Date : February 15, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

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.



Primary Outcome Measures :
  1. The cure rate of 2019-nCoV. [ Time Frame: 6 months ]
    Percentage

  2. The improvement rate of 2019-nCoV. [ Time Frame: 6 months ]
    Percentage

  3. The incidence of long-term adverse outcomes. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Duration of fever [ Time Frame: 2 weeks ]
    Days

  2. Duration of respiratory symptoms [ Time Frame: 2 weeks ]
    Days

  3. Duration of hospitalization [ Time Frame: 2 weeks ]
    Days

  4. Number of participant(s) need intensive care [ Time Frame: 2 weeks ]
  5. Number of participant(s) with acute respiratory distress syndrome [ Time Frame: 2 weeks ]
  6. Number of participant(s) with extra-pulmonary complications, including shock, renal failure, multiple organ failure, hemophagocytosis syndrome, et al. [ Time Frame: 2 weeks ]
  7. Number of participant(s) who died during the trial [ Time Frame: 10 months ]

Biospecimen Retention:   Samples Without DNA
Serum


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04270383


Contacts
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Contact: Baoping Xu, MD,PhD 861059616308 xubaopingbch@163.com
Contact: Kunling Shen, MD,PhD kunlingshen1717@163.com

Locations
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China
Beijing Children's Hospital,
Beijing, China
Contact: Lina Wang         
Sponsors and Collaborators
Beijing Children's Hospital
Capital Institute of Pediatrics, China
The First Affiliated Hospital of Anhui Medical University
China-Japan Friendship Hospital
The First Affiliated Hospital of Xiamen University
Guangzhou Women and Children's Medical Center
Shenzhen Children's Hospital
First Affiliated Hospital of Guangxi Medical University
The Affiliated Hospital Of Guizhou Medical University
Hainan People's Hospital
Children's Hospital of Hebei Province
Wuhan Women and Children's Medical Center
Changchun Children's Hospital
Children’s Hospital of Nanjing Medical University
Jiangxi Province Children's Hospital
Shengjing Hospital
Shanxi Provincial Maternity and Children's Hospital
Xian Children's Hospital
Children's Hospital of Chongqing Medical University
Tianjin Children's Hospital
Tianjin Medical University Second Hospital
Kunming Children's Hospital
Second Affiliated Hospital of Wenzhou Medical University
Investigators
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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
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Responsible Party: Kunling Shen, Director of National Clinical Research Center for Respiratory Diseases, China, Beijing Children's Hospital
ClinicalTrials.gov Identifier: NCT04270383    
Other Study ID Numbers: BCH Lung 012
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kunling Shen, Beijing Children's Hospital:
2019-nCoV infection
2019-nCoV pneumonia
Children
Additional relevant MeSH terms:
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Infection