- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04336956
Covid-19 Pediatric Observatory (PANDOR)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Corinne Levy, MD
- Phone Number: 0033 148850404
- Email: corinne.levy@activ-france.fr
Study Locations
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Agen, France
- Recruiting
- Ch St Esprit
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Contact:
- Marie Mizzi
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Aix-en-Provence, France
- Recruiting
- Ch General Aix En Provence -
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Contact:
- Claire Charreton
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Angers, France
- Recruiting
- CHU Angers
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Contact:
- Gerald Boussicault
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Sub-Investigator:
- Leboucher
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Sub-Investigator:
- Valérie Rabier
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Angoulème, France
- Recruiting
- CH D'Angouleme
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Contact:
- Sylvie Roullaud
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Annecy, France
- Recruiting
- Pringy - Ch D'Annecy
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Contact:
- Chantal Peigne
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Argenteuil, France
- Recruiting
- CH Argenteuil
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Contact:
- Philippe Bensaid, MD
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Armentières, France
- Recruiting
- Ch Armentieres
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Contact:
- Sophie Enchery
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Arpajon, France
- Recruiting
- CH Arpajon
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Contact:
- Ekaterina KUTSIA
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Auxerre, France
- Recruiting
- Ch Auxerre
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Contact:
- Bertrand Soto
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Sub-Investigator:
- Mougenot
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Avignon, France
- Recruiting
- CH GENERAL Henri Duffaut
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Contact:
- Charlotte Pons
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Besançon, France
- Recruiting
- CHU de Besancon
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Contact:
- Raphaël Anxionnat
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Caen, France
- Recruiting
- Hopital Femme Enfant
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Sub-Investigator:
- Valentin
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Cergy-Pontoise, France
- Recruiting
- CH de Pontoise
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Contact:
- Blandine Robert
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Sub-Investigator:
- Mohamed-Amine Yangui
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Chalon-sur-Saône, France
- Recruiting
- Ch W. Morey
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Chambéry, France
- Recruiting
- CH de Chambery
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Contact:
- Charlène Dupré
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Chartres, France
- Recruiting
- Ch Hotel Dieu
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Contact:
- Rémi Kom
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Clermont-Ferrand, France
- Recruiting
- CHU Estaing
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Contact:
- Isabelle Petit
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Colmar, France
- Recruiting
- Hôpital Louis Pasteur
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Contact:
- Didier CHOGNOT
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Principal Investigator:
- Marie Szulc
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Colombes, France
- Recruiting
- Hopital Louis Mourrier
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Contact:
- Danekova
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Corbeil-Essonnes, France
- Recruiting
- CH SUd Francilien
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Contact:
- Sebastien Rouget
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Creteil, France, 94010
- Recruiting
- Centre Hospitalier Intercommunal de Créteil
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Principal Investigator:
- Xavier DURRMEYER
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Contact:
- Camille Jung
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Sub-Investigator:
- Ralph EPAUD
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Sub-Investigator:
- Fouad Madhi
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Dax, France
- Recruiting
- CH de Dax
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Contact:
- Claude Chenel
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Dijon, France
- Recruiting
- Hopital D'Enfants Chu Dijon
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Contact:
- Frédéric Huet
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Sub-Investigator:
- Verney
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Elbeuf, France
- Recruiting
- CH Louviers Val de Reuil
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Contact:
- Dana Dabbagh
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Gonesse, France
- Recruiting
- CH Gonesse
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Contact:
- Maryssa Sarakbi
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Hyères, France
- Recruiting
- CH d'HYERES
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Contact:
- danielle Roybet
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Jossigny, France
- Recruiting
- CH de Marne la Vallée
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Contact:
- Nathalie Garrec
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Sub-Investigator:
- Videsheka MADPATHAGE SENANAYAKE
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Sub-Investigator:
- Tchadie Bommenel
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La Tronche, France
- Recruiting
- CHRU de Grenoble
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Contact:
- Cécile Bost-Bru
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Principal Investigator:
- Fruscione
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Le Havre, France
- Recruiting
- CHGénéral du HAVRE
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Contact:
- Belgaid Abdelmalek
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Lille, France
- Recruiting
- Hopital Jeanne de Flandre
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Contact:
- Stéphane Leteurtre
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Lille, France
- Recruiting
- Hopital Roger Salengro - Lille
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Contact:
- François DUBOS, MD
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Principal Investigator:
- Alain Martinot
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Lille, France
- Recruiting
- Hôpital Saint Vincent de Paul
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Contact:
- Valentine Hoeusler
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Principal Investigator:
- Nicolas Kalach
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Longjumeau, France
- Recruiting
- CH de Longjumeau
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Contact:
- Sarah Ducrocq
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Lorient, France
- Recruiting
- Lorient - Ch de Bretagne Sud
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Contact:
- Camille Le Stradic, MD
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Lyon, France
- Recruiting
- Hopital Femme Mere Enfant-Bron
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Contact:
- Manon Passard
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Principal Investigator:
- Manon Passard
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Principal Investigator:
- Antoine Ouziel
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Mantes-la-Jolie, France
- Recruiting
- Hopital de Mantes
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Contact:
- Béatrice Pellegrino
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Marseille, France
- Recruiting
- Hopital Nord Enfants
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Contact:
- Philippe Minodier
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Meaux, France
- Recruiting
- Hôpital de Meaux
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Contact:
- Olivier Vignaud
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Sub-Investigator:
- Fleury Marjory
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Meulin, France
- Recruiting
- CH de Melun
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Contact:
- Caroline Thach
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Montargis, France
- Recruiting
- CH de Montargis
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Contact:
- Richard Gruss
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Montbrison, France
- Recruiting
- CH de MONTBRISON
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Contact:
- Christine Roche
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Montpellier, France
- Recruiting
- Hopital Arnaud de Villeneuve
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Contact:
- Léa THEVENET
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Nancy, France
- Recruiting
- CHRU de Nancy
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Contact:
- Florent Girard
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Principal Investigator:
- Cyril Schweitzer
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Nantes, France
- Recruiting
- Nantes - Hopital Mere Enfant
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Contact:
- Anne Drouard
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Neuilly-sur-Seine, France
- Recruiting
- Ch de Neuilly Sur Seine
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Contact:
- Mariana Marin
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Nice, France
- Recruiting
- Hôpital Lenval
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Contact:
- hervé Haas
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Nîmes, France
- Recruiting
- CHU NIMES Caremeau
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Contact:
- Sophie Odorico, MD
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Orléans, France
- Recruiting
- CHR Orléans
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Contact:
- Françoise Monceaux
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Principal Investigator:
- Imen Jhaouat
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Paris, France, 75004
- Recruiting
- Assistance Publique Hopitaux De Paris
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Principal Investigator:
- Valérie Biran
-
Contact:
- François Angoulvant
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Principal Investigator:
- François Angoulvant
-
Principal Investigator:
- Albert Faye
-
Principal Investigator:
- Naim Ouldali
-
Principal Investigator:
- Mickael Levy
-
Principal Investigator:
- laurent Dupic
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Principal Investigator:
- julie Toubiana
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Principal Investigator:
- Jean Gaschignard
-
Principal Investigator:
- Nevena Danekava
-
Principal Investigator:
- Jeremy Do Cao
-
Principal Investigator:
- Karen Milcent
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Principal Investigator:
- Sebastien Walser
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Principal Investigator:
- Loic De Pontual
-
Principal Investigator:
- Gregoire Benoist
-
Principal Investigator:
- Tama Guiddir
-
Principal Investigator:
- Irina Craiu
-
Principal Investigator:
- Anne-Sophie Romain
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Principal Investigator:
- David Dawei
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Perpignan, France
- Recruiting
- Hopital St Jean Roussillon
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Contact:
- Paulin Meslin
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Poissy, France
- Recruiting
- POISSY - CH de POISSY
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Contact:
- Philippe Blanc
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Quimper, France
- Recruiting
- QUIMPER - CH de Cornouaille
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Contact:
- Camille Loeile
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RANG du FLIERS, France
- Recruiting
- RANG du FLIERS - C.H.A.M.
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Contact:
- Sylvie Louf
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Reims, France
- Recruiting
- Hopital Américain CHU REIMS
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Contact:
- Elmerich Florence
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Rodez, France
- Recruiting
- CH Rodez
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Contact:
- Bernard Caurier
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Romans-sur-Isère, France
- Recruiting
- CH de ROMANS
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Contact:
- Patricia Guglielmino
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Rouen, France
- Recruiting
- CHU Rouen
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Contact:
- Nathalie Mestre
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Rouen, France
- Recruiting
- Hôpital Charles-Nicolle
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Saint Etienne, France
- Recruiting
- CHU St Etienne
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Contact:
- Aymeric CANTAIS
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Saint-Denis, France
- Recruiting
- Ch de Saint Denis
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Contact:
- Alexis Mandelcwajg, MD
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Saint-Malo, France
- Recruiting
- CH de Saint Malo
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Contact:
- Jean-Marie Lepage
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Sallanches, France
- Recruiting
- Ch Du Pays Du Mont Blanc
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Contact:
- Emmanuelle Dessioux
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Salon de Provence, France
- Recruiting
- Chg Salon de Provence
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Contact:
- Eric Moulène
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Strasbourg, France
- Recruiting
- CH Hautepierre
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Contact:
- Jeanne Bordet
-
Principal Investigator:
- Yvan De Feraudy
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Tarbes, France
- Recruiting
- CH Tarbes
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Contact:
- Vanessa Latry, MD
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Thionville, France
- Recruiting
- CH Bel Air
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Contact:
- Jean-Marc Schneider
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Toulon, France
- Recruiting
- Hôpital Sainte Musse
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Contact:
- Paul Casha
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Toulouse, France
- Recruiting
- CHU Toulouse-hôpital des Enfants
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Contact:
- camille Brehin
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Tours, France
- Recruiting
- Hôpital Gatien De Clocheville
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Contact:
- Zoha Maakaroun-Vermesse
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Principal Investigator:
- Charlotte Idier
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Troyes, France
- Recruiting
- CH de Troyes
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Contact:
- Brigitte zimmerman
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Principal Investigator:
- Stéphane Sanchez
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Principal Investigator:
- Brigitte zimmerman
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Trévenans, France
- Recruiting
- Hôpital Nord Franche-Comté
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Contact:
- Nicoleta Ursulescu
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Vannes, France
- Recruiting
- CH Bretagne Atlantique
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Contact:
- Cécilia Marques, MD
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Versailles, France
- Recruiting
- Ch Le Chesnay
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Contact:
- Marie-Aliette Dommergue
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Principal Investigator:
- Marie-Aliette Dommergue
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Villeneuve-Saint-Georges, France
- Recruiting
- Hopital de Villeneuve Saint Georges
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Contact:
- Aurélie Garraffo, MD
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Épinal, France
- Recruiting
- CH Jean Monnet
-
Contact:
- Brigitte Auburtin
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La Réunion
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Saint Denis, La Réunion, France
- Recruiting
- CHU Felix Guyon
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Contact:
- Benjamin Azemar
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
All patients under 18 years hospitalized with a covid19 diagnosis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of children with severe or critical form.
Time Frame: Day 14
|
Day 14
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of children requiring intensive care support
Time Frame: at admission
|
at admission
|
|
Percentage of children requiring intensive care support
Time Frame: at day 14
|
at day 14
|
|
Clinical symptoms of children
Time Frame: at admission
|
requiring intensive care support or not
|
at admission
|
Clinical symptoms of children
Time Frame: day 14
|
requiring intensive care support or not
|
day 14
|
Biological results of children
Time Frame: at admission
|
requiring intensive care support or not
|
at admission
|
Biological results of children
Time Frame: day 14
|
requiring intensive care support or not
|
day 14
|
CT chest of children
Time Frame: at admission
|
requiring intensive care support or not
|
at admission
|
Pulmonary echography
Time Frame: Day 14
|
requiring intensive care support or not
|
Day 14
|
nasopharynx SARScov2 PCR
Time Frame: at admission
|
at admission
|
|
nasopharynx sarscov2 load
Time Frame: at day 7
|
if available
|
at day 7
|
nasopharynx multiplex PCR
Time Frame: at admission
|
if available
|
at admission
|
number of hospital days
Time Frame: up to 12months
|
days
|
up to 12months
|
Evaluation of long covid
Time Frame: up to 12months
|
up to 12months
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
- Association of Intravenous Immunoglobulins Plus Methylprednisolone vs Immunoglobulins Alone With Course of Fever in Multisystem Inflammatory Syndrome in Children
- Factors Associated With Severe SARS-CoV-2 Infection
- Educational Setting and SARS-CoV-2 Transmission Among Children With Multisystem Inflammatory Syndrome: A French National Surveillance System
- Analysis of COVID-19 Vaccination Status Among Parents of Hospitalized Children Younger Than 5 Years With SARS-CoV-2 Infection During the Delta and Omicron Waves
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PANDOR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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