Covid-19 Pediatric Observatory

COVID-19 Clinical Trial

— PANDOR  

Official title:

Covid-19 Pediatric Observatory

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04336956
• Other study ID #: PANDOR
• Status: Recruiting
• Start date: April 7, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2022
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: Corinne Levy, MD
• Phone: 148850404
• Email: corinne.levy[@]activ-france.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• hospitalized children with Covid19
All patients under 18 years hospitalized with a covid19 diagnosis

Locations

Country	Name	City	State
France	Ch St Esprit	Agen
France	Ch General Aix En Provence -	Aix-en-Provence
France	CHU Angers	Angers
France	CH d'ANGOULEME	Angoulème
France	Pringy - Ch D'Annecy	Annecy
France	CH Argenteuil	Argenteuil
France	Ch Armentieres	Armentières
France	CH Arpajon	Arpajon
France	Ch Auxerre	Auxerre
France	CH GENERAL Henri Duffaut	Avignon
France	CHU de BESANCON	Besançon
France	Hopital Femme Enfant	Caen
France	Ch de Pontoise	Cergy-Pontoise
France	Ch W. Morey	Chalon-sur-Saône
France	CH de CHAMBERY	Chambéry
France	Ch Hotel Dieu	Chartres
France	CHU Estaing	Clermont-Ferrand
France	Hopital Louis Pasteur	Colmar
France	Hopital Louis Mourrier	Colombes
France	CH Sud Francilien	Corbeil-Essonnes
France	Centre Hospitalier intercommunal de Creteil	Creteil
France	Ch de Dax	Dax
France	Hopital D'Enfants Chu Dijon	Dijon
France	CH Louviers Val de Reuil	Elbeuf
France	CH Jean Monnet	Épinal
France	CH Gonesse	Gonesse
France	CH d'HYERES	Hyères
France	Ch de Marne La Vallee	Jossigny
France	Chru de Grenoble	La Tronche
France	CHGénéral du HAVRE	Le Havre
France	Hopital Jeanne de Flandre	Lille
France	Hopital Roger Salengro - Lille	Lille
France	Hopital Saint Vincent de Paul	Lille
France	Ch de Longjumeau	Longjumeau
France	Lorient - Ch de Bretagne Sud	Lorient
France	Hopital Femme Mere Enfant-Bron	Lyon
France	Hopital de Mantes	Mantes-la-Jolie
France	Hopital Nord Enfants	Marseille
France	Hopital de Meaux	Meaux
France	Ch de Melun	Meulin
France	CH de Montargis	Montargis
France	CH de MONTBRISON	Montbrison
France	Hopital Arnaud de Villeneuve	Montpellier
France	CHRU de Nancy	Nancy
France	Nantes - Hopital Mere Enfant	Nantes
France	Ch de Neuilly Sur Seine	Neuilly-sur-Seine
France	Hopital Lenval	Nice
France	CHU Nimes Caremeau	Nîmes
France	Chr Orleans	Orléans
France	Assistance Publique Hôpitaux de Paris	Paris
France	Hopital St Jean Roussillon	Perpignan
France	POISSY - CH de POISSY	Poissy
France	QUIMPER - CH de Cornouaille	Quimper
France	RANG du FLIERS - C.H.A.M.	RANG du FLIERS
France	Hopital Américain CHU REIMS	Reims
France	CH RODEZ	Rodez
France	CH de ROMANS	Romans-sur-Isère
France	Chu Rouen	Rouen
France	Hopital Charles-Nicolle	Rouen
France	Chu Felix Guyon	Saint Denis	La Réunion
France	Chu St Etienne	Saint Etienne
France	Ch de Saint Denis	Saint-Denis
France	Ch de Saint Malo	Saint-Malo
France	Ch Du Pays Du Mont Blanc	Sallanches
France	Chg Salon de Provence	Salon de Provence
France	CH Hautepierre	Strasbourg
France	CH Tarbes	Tarbes
France	CH Bel Air	Thionville
France	Hopital Sainte Musse	Toulon
France	CHU Toulouse-hôpital des Enfants	Toulouse
France	Hôpital Gatien De Clocheville	Tours
France	Hôpital Nord Franche-Comté	Trévenans
France	CH de TROYES	Troyes
France	Ch Bretagne Atlantique	Vannes
France	Ch Le Chesnay	Versailles
France	Hopital de Villeneuve Saint Georges	Villeneuve-Saint-Georges

Sponsors (5)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil	Association Clinique Thérapeutique Infantile du val de Marne, Francophone Pediatric Resuscitation and Emergency Group (GFRUP), GPIP, Société Française de Pédiatrie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of children with severe or critical form.		Day 14
Secondary	Percentage of children requiring intensive care support		at admission
Secondary	Percentage of children requiring intensive care support		at day 14
Secondary	Clinical symptoms of children	requiring intensive care support or not	at admission
Secondary	Clinical symptoms of children	requiring intensive care support or not	day 14
Secondary	Biological results of children	requiring intensive care support or not	at admission
Secondary	Biological results of children	requiring intensive care support or not	day 14
Secondary	CT chest of children	requiring intensive care support or not	at admission
Secondary	Pulmonary echography	requiring intensive care support or not	Day 14
Secondary	nasopharynx SARScov2 PCR		at admission
Secondary	nasopharynx sarscov2 load	if available	at day 7
Secondary	nasopharynx multiplex PCR	if available	at admission
Secondary	number of hospital days	days	up to 12months
Secondary	Evaluation of long covid		up to 12months

External Links

•   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
•   Association of Intravenous Immunoglobulins Plus Methylprednisolone vs Immunoglobulins Alone With Course of Fever in Multisystem Inflammatory Syndrome in Children
•   Educational Setting and SARS-CoV-2 Transmission Among Children With Multisystem Inflammatory Syndrome: A French National Surveillance System
•   Factors Associated With Severe SARS-CoV-2 Infection