2019-nCoV Clinical Trial
Official title:
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.
Status | Not yet recruiting |
Enrollment | 500 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Children's Hospital, | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Children's Hospital | Capital Institute of Pediatrics, China, Changchun Children's Hospital, Children's Hospital of Chongqing Medical University, Children's Hospital of Hebei Province, Children’s Hospital of Nanjing Medical University, China-Japan Friendship Hospital, First Affiliated Hospital of Guangxi Medical University, Guangzhou Women and Children's Medical Center, Hainan People's Hospital, Jiangxi Province Children's Hospital, Kunming Children's Hospital, Second Affiliated Hospital of Wenzhou Medical University, Shanxi Provincial Maternity and Children's Hospital, Shengjing Hospital, Shenzhen Children's Hospital, The Affiliated Hospital Of Guizhou Medical University, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Xiamen University, Tianjin Children's Hospital, Tianjin Medical University Second Hospital, Wuhan Women and Children's Medical Center, Xian Children's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The cure rate of 2019-nCoV. | Percentage | 6 months | |
Primary | The improvement rate of 2019-nCoV. | Percentage | 6 months | |
Primary | The incidence of long-term adverse outcomes. | 6 months | ||
Secondary | Duration of fever | Days | 2 weeks | |
Secondary | Duration of respiratory symptoms | Days | 2 weeks | |
Secondary | Duration of hospitalization | Days | 2 weeks | |
Secondary | Number of participant(s) need intensive care | 2 weeks | ||
Secondary | Number of participant(s) with acute respiratory distress syndrome | 2 weeks | ||
Secondary | Number of participant(s) with extra-pulmonary complications, including shock, renal failure, multiple organ failure, hemophagocytosis syndrome, et al. | 2 weeks | ||
Secondary | Number of participant(s) who died during the trial | 10 months |
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