Clinical trial NCT04270383: Clinical Characteristics and Long-term Prognosis of 2019-nCoV Infection in Children
Official title: A Multicenter Observational Study About the Clinical Characteristics and Long-term Prognosis of 2019-nCoV Infection in Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: 2019-nCoV
Keywords: 2019-nCoV infection
2019-nCoV pneumonia
Children
Lead sponsor: Beijing Children's Hospital
Sponsor class: OTHER
Collaborators: name: Capital Institute of Pediatrics, China
name: The First Affiliated Hospital of Anhui Medical University
name: China-Japan Friendship Hospital
name: The First Affiliated Hospital of Xiamen University
name: Guangzhou Women and Children's Medical Center
name: Shenzhen Children's Hospital
name: First Affiliated Hospital of Guangxi Medical University
name: The Affiliated Hospital Of Guizhou Medical University
name: Hainan People's Hospital
name: Children's Hospital of Hebei Province
name: Wuhan Women and Children's Medical Center
name: Changchun Children's Hospital
name: Children's Hospital of Nanjing Medical University
name: Jiangxi Province Children's Hospital
name: Shengjing Hospital
name: Shanxi Provincial Maternity and Children's Hospital
name: Xian Children's Hospital
name: Children's Hospital of Chongqing Medical University
name: Tianjin Children's Hospital
name: Tianjin Medical University Second Hospital
name: Kunming Children's Hospital
name: Second Affiliated Hospital of Wenzhou Medical University
First posted: 2020-02-17
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: The cure rate of 2019-nCoV.
timeFrame: 6 months
measure: The improvement rate of 2019-nCoV.
timeFrame: 6 months
measure: The incidence of long-term adverse outcomes.
timeFrame: 6 months
Secondary outcomes:
measure: Duration of fever
timeFrame: 2 weeks
measure: Duration of respiratory symptoms
timeFrame: 2 weeks
measure: Duration of hospitalization
timeFrame: 2 weeks
measure: Number of participant(s) need intensive care
timeFrame: 2 weeks
measure: Number of participant(s) with acute respiratory distress syndrome
timeFrame: 2 weeks
measure: Number of participant(s) with extra-pulmonary complications, including shock, renal failure, multiple organ failure, hemophagocytosis syndrome, et al.
timeFrame: 2 weeks
measure: Number of participant(s) who died during the trial
timeFrame: 10 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Children's Hospital,
Study officials:
affiliation: Beijing Children's Hospital of Capital Medical University, China
name: Kunling Shen, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Children's Hospital of Capital Medical University, China
name: Tianyou Wang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Children's Hospital of Capital Medical University, China
name: Baoping Xu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: