Clinical trial NCT04336956: Covid-19 Pediatric Observatory
Official title: Covid-19 Pediatric Observatory
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: children
pediatric department
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
Collaborators: name: Association Clinique Thérapeutique Infantile du val de Marne
name: Groupe de Pathologies Infectieuses Pédiatriques (GPIP)
name: Société Française de Pédiatrie
name: Francophone Pediatric Resuscitation and Emergency Group (GFRUP)
First posted: 2020-04-07
Enrollment: 5000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children hospitalized with covid19

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of children with severe or critical form.
timeFrame: Day 14
Secondary outcomes:
measure: Percentage of children requiring intensive care support
timeFrame: at admission
measure: Percentage of children requiring intensive care support
timeFrame: at day 14
measure: Clinical symptoms of children
timeFrame: at admission
measure: Clinical symptoms of children
timeFrame: day 14
measure: Biological results of children
timeFrame: at admission
measure: Biological results of children
timeFrame: day 14
measure: CT chest of children
timeFrame: at admission
measure: Pulmonary echography
timeFrame: Day 14
measure: nasopharynx SARScov2 PCR
timeFrame: at admission
measure: nasopharynx sarscov2 load
timeFrame: at day 7
measure: nasopharynx multiplex PCR
timeFrame: at admission
measure: number of hospital days
timeFrame: up to 12months
measure: Evaluation of long covid
timeFrame: up to 12months
Other outcomes:
Locations:
city: Saint Denis
country: France
facility: Chu Felix Guyon
state: La Réunion
city: Agen
country: France
facility: Ch St Esprit
city: Aix-en-Provence
country: France
facility: Ch General Aix En Provence -
city: Angers
country: France
facility: CHU Angers
city: Angoulème
country: France
facility: CH d'ANGOULEME
city: Annecy
country: France
facility: Pringy - Ch D'Annecy
city: Argenteuil
country: France
facility: CH Argenteuil
city: Armentières
country: France
facility: Ch Armentieres
city: Arpajon
country: France
facility: CH Arpajon
city: Auxerre
country: France
facility: Ch Auxerre
city: Avignon
country: France
facility: CH GENERAL Henri Duffaut
city: Besançon
country: France
facility: CHU de BESANCON
city: Caen
country: France
facility: Hopital Femme Enfant
city: Cergy-Pontoise
country: France
facility: Ch de Pontoise
city: Chalon-sur-Saône
country: France
facility: Ch W. Morey
city: Chambéry
country: France
facility: CH de CHAMBERY
city: Chartres
country: France
facility: Ch Hotel Dieu
city: Clermont-Ferrand
country: France
facility: CHU Estaing
city: Colmar
country: France
facility: Hopital Louis Pasteur
city: Colombes
country: France
facility: Hopital Louis Mourrier
city: Corbeil-Essonnes
country: France
facility: CH Sud Francilien
city: Creteil
country: France
facility: Centre Hospitalier intercommunal de Creteil
city: Dax
country: France
facility: Ch de Dax
city: Dijon
country: France
facility: Hopital D'Enfants Chu Dijon
city: Elbeuf
country: France
facility: CH Louviers Val de Reuil
city: Gonesse
country: France
facility: CH Gonesse
city: Hyères
country: France
facility: CH d'HYERES
city: Jossigny
country: France
facility: Ch de Marne La Vallee
city: La Tronche
country: France
facility: Chru de Grenoble
city: Le Havre
country: France
facility: CHGénéral du HAVRE
city: Lille
country: France
facility: Hopital Jeanne de Flandre
city: Lille
country: France
facility: Hopital Roger Salengro - Lille
city: Lille
country: France
facility: Hopital Saint Vincent de Paul
city: Longjumeau
country: France
facility: Ch de Longjumeau
city: Lorient
country: France
facility: Lorient - Ch de Bretagne Sud
city: Lyon
country: France
facility: Hopital Femme Mere Enfant-Bron
city: Mantes-la-Jolie
country: France
facility: Hopital de Mantes
city: Marseille
country: France
facility: Hopital Nord Enfants
city: Meaux
country: France
facility: Hopital de Meaux
city: Meulin
country: France
facility: Ch de Melun
city: Montargis
country: France
facility: CH de Montargis
city: Montbrison
country: France
facility: CH de MONTBRISON
city: Montpellier
country: France
facility: Hopital Arnaud de Villeneuve
city: Nancy
country: France
facility: CHRU de Nancy
city: Nantes
country: France
facility: Nantes - Hopital Mere Enfant
city: Neuilly-sur-Seine
country: France
facility: Ch de Neuilly Sur Seine
city: Nice
country: France
facility: Hopital Lenval
city: Nîmes
country: France
facility: CHU Nimes Caremeau
city: Orléans
country: France
facility: Chr Orleans
city: Paris
country: France
facility: Assistance Publique Hôpitaux de Paris
city: Perpignan
country: France
facility: Hopital St Jean Roussillon
city: Poissy
country: France
facility: POISSY - CH de POISSY
city: Quimper
country: France
facility: QUIMPER - CH de Cornouaille
city: RANG du FLIERS
country: France
facility: RANG du FLIERS - C.H.A.M.
city: Reims
country: France
facility: Hopital Américain CHU REIMS
city: Rodez
country: France
facility: CH RODEZ
city: Romans-sur-Isère
country: France
facility: CH de ROMANS
city: Rouen
country: France
facility: Chu Rouen
city: Rouen
country: France
facility: Hopital Charles-Nicolle
city: Saint Etienne
country: France
facility: Chu St Etienne
city: Saint-Denis
country: France
facility: Ch de Saint Denis
city: Saint-Malo
country: France
facility: Ch de Saint Malo
city: Sallanches
country: France
facility: Ch Du Pays Du Mont Blanc
city: Salon de Provence
country: France
facility: Chg Salon de Provence
city: Strasbourg
country: France
facility: CH Hautepierre
city: Tarbes
country: France
facility: CH Tarbes
city: Thionville
country: France
facility: CH Bel Air
city: Toulon
country: France
facility: Hopital Sainte Musse
city: Toulouse
country: France
facility: CHU Toulouse-hôpital des Enfants
city: Tours
country: France
facility: Hôpital Gatien De Clocheville
city: Troyes
country: France
facility: CH de TROYES
city: Trévenans
country: France
facility: Hôpital Nord Franche-Comté
city: Vannes
country: France
facility: Ch Bretagne Atlantique
city: Versailles
country: France
facility: Ch Le Chesnay
city: Villeneuve-Saint-Georges
country: France
facility: Hopital de Villeneuve Saint Georges
city: Épinal
country: France
facility: CH Jean Monnet
Study officials:
References: