NCT04336956

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Longer than P75 for all trials

Geographic Reach
1 country

76 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 7, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 7, 2020

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

November 25, 2022

Status Verified

November 1, 2022

Enrollment Period

4.2 years

First QC Date

March 30, 2020

Last Update Submit

November 21, 2022

Conditions

Keywords

childrenpediatric department

Outcome Measures

Primary Outcomes (1)

  • Percentage of children with severe or critical form.

    Day 14

Secondary Outcomes (13)

  • Percentage of children requiring intensive care support

    at admission

  • Percentage of children requiring intensive care support

    at day 14

  • Clinical symptoms of children

    at admission

  • Clinical symptoms of children

    day 14

  • Biological results of children

    at admission

  • +8 more secondary outcomes

Study Arms (1)

hospitalized children with Covid19

\- 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

Interventions

All patients under 18 years hospitalized with a covid19 diagnosis

hospitalized children with Covid19

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

children hospitalized with covid19

You may qualify if:

  • 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

You may not qualify if:

  • Expressed refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (76)

Chu Felix Guyon

Saint-Denis, La Réunion, France

RECRUITING

Ch St Esprit

Agen, France

RECRUITING

Ch General Aix En Provence -

Aix-en-Provence, France

RECRUITING

CHU Angers

Angers, France

RECRUITING

CH d'ANGOULEME

Angoulème, France

RECRUITING

Pringy - Ch D'Annecy

Annecy, France

RECRUITING

CH Argenteuil

Argenteuil, France

RECRUITING

Ch Armentieres

Armentières, France

RECRUITING

CH Arpajon

Arpajon, France

RECRUITING

Ch Auxerre

Auxerre, France

RECRUITING

CH GENERAL Henri Duffaut

Avignon, France

RECRUITING

CHU de BESANCON

Besançon, France

RECRUITING

Hopital Femme Enfant

Caen, France

RECRUITING

Ch de Pontoise

Cergy-Pontoise, France

RECRUITING

Ch W. Morey

Chalon-sur-Saône, France

RECRUITING

CH de CHAMBERY

Chambéry, France

RECRUITING

Ch Hotel Dieu

Chartres, France

RECRUITING

CHU Estaing

Clermont-Ferrand, France

RECRUITING

Hopital Louis Pasteur

Colmar, France

RECRUITING

Hopital Louis Mourrier

Colombes, France

RECRUITING

CH Sud Francilien

Corbeil-Essonnes, France

RECRUITING

Centre Hospitalier intercommunal de Creteil

Créteil, 94010, France

RECRUITING

Ch de Dax

Dax, France

RECRUITING

Hopital D'Enfants Chu Dijon

Dijon, France

RECRUITING

CH Louviers Val de Reuil

Elbeuf, France

RECRUITING

CH Jean Monnet

Épinal, France

RECRUITING

CH Gonesse

Gonesse, France

RECRUITING

CH d'HYERES

Hyères, France

RECRUITING

Ch de Marne La Vallee

Jossigny, France

RECRUITING

Chru de Grenoble

La Tronche, France

RECRUITING

CHGénéral du HAVRE

Le Havre, France

RECRUITING

Hopital Jeanne de Flandre

Lille, France

RECRUITING

Hopital Roger Salengro - Lille

Lille, France

RECRUITING

Hopital Saint Vincent de Paul

Lille, France

RECRUITING

Ch de Longjumeau

Longjumeau, France

RECRUITING

Lorient - Ch de Bretagne Sud

Lorient, France

RECRUITING

Hopital Femme Mere Enfant-Bron

Lyon, France

RECRUITING

Hopital de Mantes

Mantes-la-Jolie, France

RECRUITING

Hopital Nord Enfants

Marseille, France

RECRUITING

Hopital de Meaux

Meaux, France

RECRUITING

Ch de Melun

Meulin, France

RECRUITING

CH de Montargis

Montargis, France

RECRUITING

CH de MONTBRISON

Montbrison, France

RECRUITING

Hopital Arnaud de Villeneuve

Montpellier, France

RECRUITING

CHRU de Nancy

Nancy, France

RECRUITING

Nantes - Hopital Mere Enfant

Nantes, France

RECRUITING

Ch de Neuilly Sur Seine

Neuilly-sur-Seine, France

RECRUITING

Hopital Lenval

Nice, France

RECRUITING

CHU Nimes Caremeau

Nîmes, France

RECRUITING

Chr Orleans

Orléans, France

RECRUITING

Assistance Publique Hôpitaux de Paris

Paris, 75004, France

RECRUITING

Hopital St Jean Roussillon

Perpignan, France

RECRUITING

POISSY - CH de POISSY

Poissy, France

RECRUITING

QUIMPER - CH de Cornouaille

Quimper, France

RECRUITING

RANG du FLIERS - C.H.A.M.

Rang-du-Fliers, France

RECRUITING

Hopital Américain CHU REIMS

Reims, France

RECRUITING

CH RODEZ

Rodez, France

RECRUITING

CH de ROMANS

Romans-sur-Isère, France

RECRUITING

Chu Rouen

Rouen, France

RECRUITING

Hopital Charles-Nicolle

Rouen, France

RECRUITING

Ch de Saint Denis

Saint-Denis, France

RECRUITING

Chu St Etienne

Saint-Etienne, France

RECRUITING

Ch Du Pays Du Mont Blanc

Sallanches, France

RECRUITING

Chg Salon de Provence

Salon-de-Provence, France

RECRUITING

Ch de Saint Malo

St-Malo, France

RECRUITING

CH Hautepierre

Strasbourg, France

RECRUITING

CH Tarbes

Tarbes, France

RECRUITING

CH Bel Air

Thionville, France

RECRUITING

Hopital Sainte Musse

Toulon, France

RECRUITING

CHU Toulouse-hôpital des Enfants

Toulouse, France

RECRUITING

Hôpital Gatien De Clocheville

Tours, France

RECRUITING

Hôpital Nord Franche-Comté

Trévenans, France

RECRUITING

CH de TROYES

Troyes, France

RECRUITING

Ch Bretagne Atlantique

Vannes, France

RECRUITING

Ch Le Chesnay

Versailles, France

RECRUITING

Hopital de Villeneuve Saint Georges

Villeneuve-Saint-Georges, France

RECRUITING

Related Publications (1)

  • Rybak A, Ouldali N, Werner A, Casha P, Robert B, de Pontual L, Bechet S, Cahn-Sellem F, Angoulvant F, Cohen R, Levy C; PANDOR study group. Characteristics of Children Hospitalized for Acute COVID-19 in France From February 2020 to December 2023. Pediatr Infect Dis J. 2025 Apr 1;44(4):346-350. doi: 10.1097/INF.0000000000004681. Epub 2025 Feb 14.

Related Links

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2020

First Posted

April 7, 2020

Study Start

April 7, 2020

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

November 25, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations