Clinical Characteristics and Long-term Prognosis of 2019-nCoV Infection in Children
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|ClinicalTrials.gov Identifier: NCT04270383|
Recruitment Status : Not yet recruiting
First Posted : February 17, 2020
Last Update Posted : February 17, 2020
|Condition or disease|
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|
|Estimated Enrollment :||500 participants|
|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|
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.
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.
- 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 ]
- 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 ]
Biospecimen Retention: Samples Without DNA
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
|Contact: Baoping Xu, MD,PhDfirstname.lastname@example.org|
|Contact: Kunling Shen, MD,PhDemail@example.com|
|Beijing Children's Hospital,|
|Contact: Lina Wang|
|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|