2019-nCoVNCT04270383
Clinical Characteristics and Long-term Prognosis of 2019-nCoV Infection in Children
An observational study of 2019-nCoV, run by Beijing Children's Hospital at 1 site in China.
Trial summary
The study is designed to clarify the clinical characteristics, risk factors and long-term prognosis of children with 2019-nCoV infection in China. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- 2019-nCoV
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2020to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Diagnosed with 2019-nCoV infection (with direct laboratory evidence).
- Respiratory or blood samples tested positive for novel coronavirus nucleic acid with RT-PCR.
- Gene sequencing of respiratory or blood samples show highly homologous with known novel coronaviruses.
- Diagnosed with pneumonia, and excepted of novel coronavirus infection.
- The hospitalization time is the same as that of novel coronavirus pneumonia.
Who cannot join
- Subjects will be excluded if the children or their parents disagree to conduct this study.
- For the control group
- Subject will be excluded if she or he has one of the following:
- First diagnosis is not pneumonia.
- Any one of the novel coronavirus laboratory test results show positive.
- Children or their parents disagree to conduct this study.
Trial locations and contacts
1 site in 1 country.
Kunling Shen, MD,PhD contact
About this study
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.
Read the 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.
- Conditions
- 2019-nCoV
- Keywords
- 2019-nCoV infection, 2019-nCoV pneumonia, Children
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cure rate of 2019-nCoV.
Percentage
Measured: 6 months
The improvement rate of 2019-nCoV.
Percentage
Measured: 6 months
The incidence of long-term adverse outcomes.
Measured: 6 months
Secondary outcomes (7)
Duration of fever
Days
Measured: 2 weeks
Duration of respiratory symptoms
Days
Measured: 2 weeks
Duration of hospitalization
Days
Measured: 2 weeks
Number of participant(s) need intensive care
Measured: 2 weeks
Number of participant(s) with acute respiratory distress syndrome
Measured: 2 weeks
Number of participant(s) with extra-pulmonary complications, including shock, renal failure, multiple organ failure, hemophagocytosis syndrome, et al.
Measured: 2 weeks
Number of participant(s) who died during the trial
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start15 Feb 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 2019-nCoVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Children's Hospital
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Kunling Shen, Beijing Children's Hospital
- Investigators
- Kunling Shen, MD,PhD, Principal investigator, Beijing Children's Hospital of Capital Medical University, ChinaTianyou Wang, MD,PhD, Principal investigator, Beijing Children's Hospital of Capital Medical University, ChinaBaoping Xu, MD,PhD, Principal investigator, Beijing Children's Hospital of Capital Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270383
- Sponsor's protocol ID
- BCH Lung 012
- Status last verified
- Feb 2020
- First submitted
- 11 Feb 2020
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Observational Study About the Clinical Characteristics and Long-term Prognosis of 2019-nCoV Infection in Children
- ClinicalTrials.gov ID
- NCT04270383
- Acronym / sponsor ID
- BCH Lung 012
- Conditions
- 2019-nCoV
- Keywords
- 2019-nCoV infection, 2019-nCoV pneumonia, Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Beijing Children's HospitalUniversity, hospital or other
- 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
- Study start
- 15 Feb 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- Diagnosed with 2019-nCoV infection (with direct laboratory evidence).
- Diagnosed with pneumonia, and excepted of novel coronavirus infection.
- The hospitalization time is the same as that of novel coronavirus pneumonia.
Key exclusion criteria (6 listed)
- Subjects will be excluded if the children or their parents disagree to conduct this study.
- For the control group
- First diagnosis is not pneumonia.
- Any one of the novel coronavirus laboratory test results show positive.
- Children or their parents disagree to conduct this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
Duration of fever
Time frame: 2 weeks
Duration of respiratory symptoms
Time frame: 2 weeks
Duration of hospitalization
Time frame: 2 weeks
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kunling Shen, MD,PhD contact
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 2019-nCoV, run by Beijing Children's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Baoping Xu, MD,PhD (861059616308, xubaopingbch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The cure rate of 2019-nCoV. (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.