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PANDOR: Covid-19 Pediatric Observatory

Sponsor
Centre Hospitalier Intercommunal Creteil (Other)
Overall Status
Unknown status
CT.gov ID
NCT04336956
Collaborator
Association Clinique Thérapeutique Infantile du val de Marne (Other), GPIP (Other), Société Française de Pédiatrie (Other), Francophone Pediatric Resuscitation and Emergency Group (GFRUP) (Other)
250
Enrollment
76
Locations
14.8
Anticipated Duration (Months)
3.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: hospitalized children with Covid19

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
250 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Covid-19 Pediatric Observatory
Actual Study Start Date :
Apr 7, 2020
Anticipated Primary Completion Date :
Jun 30, 2021
Anticipated Study Completion Date :
Jun 30, 2021

Arms and Interventions

Arm 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

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

Outcome Measures

Primary Outcome Measures

  1. Percentage of children with severe or critical form. [Day 14]

Secondary Outcome Measures

  1. Percentage of children requiring intensive care support [at admission]

  2. Percentage of children requiring intensive care support [at day 14]

  3. Clinical symptoms of children [at admission]

    requiring intensive care support or not

  4. Clinical symptoms of children [day 14]

    requiring intensive care support or not

  5. Biological results of children [at admission]

    requiring intensive care support or not

  6. Biological results of children [day 14]

    requiring intensive care support or not

  7. CT chest of children [at admission]

    requiring intensive care support or not

  8. Pulmonary echography [Day 14]

    requiring intensive care support or not

  9. nasopharynx SARScov2 PCR [at admission]

  10. nasopharynx sarscov2 load [at day 7]

    if available

  11. nasopharynx multiplex PCR [at admission]

    if available

  12. number of hospital days [up to 6 months]

    days

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu Felix Guyon Saint Denis La Réunion France
2 Ch St Esprit Agen France
3 Ch General Aix En Provence - Aix-en-Provence France
4 CHU Angers Angers France
5 CH d'ANGOULEME Angoulème France
6 Pringy - Ch D'Annecy Annecy France
7 CH Argenteuil Argenteuil France
8 Ch Armentieres Armentières France
9 CH Arpajon Arpajon France
10 Ch Auxerre Auxerre France
11 CH GENERAL Henri Duffaut Avignon France
12 CHU de BESANCON Besançon France
13 Hopital Femme Enfant Caen France
14 Ch de Pontoise Cergy-Pontoise France
15 Ch W. Morey Chalon-sur-Saône France
16 CH de CHAMBERY Chambéry France
17 Ch Hotel Dieu Chartres France
18 CHU Estaing Clermont-Ferrand France
19 Hopital Louis Pasteur Colmar France
20 Hopital Louis Mourrier Colombes France
21 CH Sud Francilien Corbeil-Essonnes France
22 Centre Hospitalier intercommunal de Creteil Creteil France 94010
23 Ch de Dax Dax France
24 Hopital D'Enfants Chu Dijon Dijon France
25 CH Louviers Val de Reuil Elbeuf France
26 CH Gonesse Gonesse France
27 CH d'HYERES Hyères France
28 Ch de Marne La Vallee Jossigny France
29 Chru de Grenoble La Tronche France
30 CHGénéral du HAVRE Le Havre France
31 Hopital Jeanne de Flandre Lille France
32 Hopital Roger Salengro - Lille Lille France
33 Hopital Saint Vincent de Paul Lille France
34 Ch de Longjumeau Longjumeau France
35 Lorient - Ch de Bretagne Sud Lorient France
36 Hopital Femme Mere Enfant-Bron Lyon France
37 Hopital de Mantes Mantes-la-Jolie France
38 Hopital Nord Enfants Marseille France
39 Hopital de Meaux Meaux France
40 Ch de Melun Meulin France
41 CH de Montargis Montargis France
42 CH de MONTBRISON Montbrison France
43 Hopital Arnaud de Villeneuve Montpellier France
44 CHRU de Nancy Nancy France
45 Nantes - Hopital Mere Enfant Nantes France
46 Ch de Neuilly Sur Seine Neuilly-sur-Seine France
47 Hopital Lenval Nice France
48 CHU Nimes Caremeau Nîmes France
49 Chr Orleans Orléans France
50 Assistance Publique Hôpitaux de Paris Paris France 75004
51 Hopital St Jean Roussillon Perpignan France
52 POISSY - CH de POISSY Poissy France
53 QUIMPER - CH de Cornouaille Quimper France
54 RANG du FLIERS - C.H.A.M. RANG du FLIERS France
55 Hopital Américain CHU REIMS Reims France
56 CH RODEZ Rodez France
57 CH de ROMANS Romans-sur-Isère France
58 Chu Rouen Rouen France
59 Hopital Charles-Nicolle Rouen France
60 Chu St Etienne Saint Etienne France
61 Ch de Saint Denis Saint-Denis France
62 Ch de Saint Malo Saint-Malo France
63 Ch Du Pays Du Mont Blanc Sallanches France
64 Chg Salon de Provence Salon de Provence France
65 CH Hautepierre Strasbourg France
66 CH Tarbes Tarbes France
67 CH Bel Air Thionville France
68 Hopital Sainte Musse Toulon France
69 CHU Toulouse-hôpital des Enfants Toulouse France
70 Hôpital Gatien De Clocheville Tours France
71 CH de TROYES Troyes France
72 Hôpital Nord Franche-Comté Trévenans France
73 Ch Bretagne Atlantique Vannes France
74 Ch Le Chesnay Versailles France
75 Hopital de Villeneuve Saint Georges Villeneuve-Saint-Georges France
76 CH Jean Monnet Épinal France

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier:
NCT04336956
Other Study ID Numbers:
  • PANDOR
First Posted:
Apr 7, 2020
Last Update Posted:
Jul 17, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Intercommunal Creteil
children
pediatric department
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Jul 17, 2020