Covid-19 Pediatric Observatory

Study Overview
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Brief Summary
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In early December 2019, cases of pneumonia of unknown origin were reported in Wuhan, Hubei Province in the People's Republic of China. The disease spreads rapidly and the number of sick people is increasing. On January 3, 2020 a new virus of the coronavirus family is identified in samples of bronchoalveolar lavage fluid from a patient in Wuhan and subsequently confirmed as the cause of these pneumonias. On 7 January 2020, the World Health Organization (WHO) designated it as the new coronavirus 2019 (i.e. 2019-nCoV). On 11 February 2020, the WHO designated the disease associated with 2019-nCoV as coronavirus 2019 disease (COVID-19). On 12 March, WHO announced that the COVID-19 outbreak is a pandemic. As of March 24, 2020, more than 375,000 cases of COVID-19 had been diagnosed with more than 16,000 deaths attributed to this virus. (Ref WHO https://www.who.int/emergencies/diseases/novel-coronavirus-2019 ). In France, the number of cases rose from 105 cases at the end of February to 19615 confirmed cases on March 24. (Source Public Health France). Most of the cases are adults. However, children are not completely spared and serious cases have been described. These severe cases can be respiratory or extra-respiratory (e.g. myocarditis). We also know that pediatric and adult cases differ in terms of clinical, biological and imaging findings, particularly chest CT scans. However, the description of paediatric pictures, especially severe forms and the involvement of children suffering from co-morbidities, remains poorly reported. Finally, the risk factors for serious cases in children remain largely unknown. This observatory aim to describe the clinical phenotypes of hospitalized pediatric patients with Covid19 in France, according to age groups. Moreover for a subgroup of patients, informations regarding the long covid will be reported.

Official Title
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Covid-19 Pediatric Observatory

Conditions
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COVID-19

Intervention / Treatment
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* Other: hospitalized children with Covid19


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children < 18 years old Admitted in French pediatric wards With a confirmed COVID-19 infection. ( on Nasal and pharyngeal swab specimens or blood samples tested positive for 2019-nCoV nucleic acid using real-time reverse-transcriptase polymerase-chain-reaction (RT- PCR) assay; or on typical chest CT signs Exclusion Criteria: Expressed refusal to participate

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| hospitalized children with Covid19<br>- Children < 18 years old Patients under 18 years old, admitted in French pediatric wards with a confirmed COVID-19 infection on Nasal and pharyngeal swab specimens or blood samples tested positive for 2019-nCoV nucleic acid using real-time reverse-transcriptase polymerase-chain-reaction (RT- PCR) assay; or on typical chest CT signs | Other: hospitalized children with Covid19<br>* All patients under 18 years hospitalized with a covid19 diagnosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of children with severe or critical form. |  | Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of children requiring intensive care support |  | at admission | 
| Percentage of children requiring intensive care support |  | at day 14 | 
| Clinical symptoms of children | requiring intensive care support or not | at admission | 
| Clinical symptoms of children | requiring intensive care support or not | day 14 | 
| Biological results of children | requiring intensive care support or not | at admission | 
| Biological results of children | requiring intensive care support or not | day 14 | 
| CT chest of children | requiring intensive care support or not | at admission | 
| Pulmonary echography | requiring intensive care support or not | Day 14 | 
| nasopharynx SARScov2 PCR |  | at admission | 
| nasopharynx sarscov2 load | if available | at day 7 | 
| nasopharynx multiplex PCR | if available | at admission | 
| number of hospital days | days | up to 12months | 
| Evaluation of long covid |  | up to 12months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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children, pediatric department