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COVID-19PANDORNCT04336956

Covid-19 Pediatric Observatory

An observational study of COVID-19, run by Centre Hospitalier Intercommunal Creteil at 76 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 0 to 18 years
Conditions the study is for
COVID-19
What is being tested?
hospitalized children with Covid19
How many people
5,000 participants
Where
76 sitesFrance
Study dates
7 Apr 2020to 30 Jun 2024
How long will I take part?
12 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: children hospitalized with covid19

Who may be able to join

  • 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

Who cannot join

  • Expressed refusal to participate

Trial locations and contacts

76 sites in 1 country.

Corinne Levy, MD contact

148850404 ext. 0033

corinne.levy@activ-france.fr

76 sites in 1 country

France76 sites, 76 recruiting

  • Ch St Esprit

    Agen

    Marie Mizzi

    Recruiting

  • Ch General Aix En Provence -

    Aix-en-Provence

    Claire Charreton

    Recruiting

  • CHU Angers

    Angers

    Gerald Boussicault

    Leboucher

    Recruiting

  • CH d'ANGOULEME

    Angoulème

    Sylvie Roullaud

    Recruiting

  • Pringy - Ch D'Annecy

    Annecy

    Chantal Peigne

    Recruiting

  • CH Argenteuil

    Argenteuil

    Philippe Bensaid, MD

    Recruiting

  • Ch Armentieres

    Armentières

    Sophie Enchery

    Recruiting

  • CH Arpajon

    Arpajon

    Ekaterina KUTSIA

    Recruiting

  • Ch Auxerre

    Auxerre

    Bertrand Soto

    Mougenot

    Recruiting

  • CH GENERAL Henri Duffaut

    Avignon

    Charlotte Pons

    Recruiting

  • CHU de BESANCON

    Besançon

    Raphaël Anxionnat

    Recruiting

  • Hopital Femme Enfant

    Caen

    Jacques Brouard

    Valentin

    Recruiting

  • Ch de Pontoise

    Cergy-Pontoise

    Blandine Robert

    Mohamed-Amine Yangui

    Recruiting

  • Ch W. Morey

    Chalon-sur-Saône

    Sandrine Anne Martha

    Recruiting

  • CH de CHAMBERY

    Chambéry

    Charlène Dupré

    Recruiting

  • Ch Hotel Dieu

    Chartres

    Rémi Kom

    Recruiting

  • CHU Estaing

    Clermont-Ferrand

    Isabelle Petit

    Recruiting

  • Hopital Louis Pasteur

    Colmar

    Didier Chognot

    Marie Szulc

    Recruiting

  • Hopital Louis Mourrier

    Colombes

    Danekova

    Recruiting

  • CH Sud Francilien

    Corbeil-Essonnes

    Sebastien Rouget

    Recruiting

  • Centre Hospitalier intercommunal de Creteil

    Créteil, 94010

    Camille Jung

    Xavier DURRMEYER

    Recruiting

  • Ch de Dax

    Dax

    Claude Chenel

    Recruiting

  • Hopital D'Enfants Chu Dijon

    Dijon

    Frédéric Huet

    Verney

    Recruiting

  • CH Louviers Val de Reuil

    Elbeuf

    Dana Dabbagh

    Recruiting

  • CH Jean Monnet

    Épinal

    Brigitte Auburtin

    Recruiting

  • CH Gonesse

    Gonesse

    Maryssa Sarakbi

    Recruiting

  • CH d'HYERES

    Hyères

    danielle Roybet

    Recruiting

  • Ch de Marne La Vallee

    Jossigny

    Nathalie Garrec

    Videsheka MADPATHAGE SENANAYAKE

    Recruiting

  • Chru de Grenoble

    La Tronche

    Cécile Bost-Bru

    Fruscione

    Recruiting

  • CHGénéral du HAVRE

    Le Havre

    Belgaid Abdelmalek

    Recruiting

  • Hopital Jeanne de Flandre

    Lille

    Stéphane Leteurtre

    Recruiting

  • Hopital Roger Salengro - Lille

    Lille

    François Dubos, MD

    Alain Martinot

    Recruiting

  • Hopital Saint Vincent de Paul

    Lille

    Valentine Hoeusler

    Nicolas Kalach

    Recruiting

  • Ch de Longjumeau

    Longjumeau

    Sarah Ducrocq

    Recruiting

  • Lorient - Ch de Bretagne Sud

    Lorient

    Camille Le Stradic, MD

    Recruiting

  • Hopital Femme Mere Enfant-Bron

    Lyon

    Manon Passard

    Manon Passard

    Recruiting

  • Hopital de Mantes

    Mantes-la-Jolie

    Béatrice Pellegrino

    Recruiting

  • Hopital Nord Enfants

    Marseille

    Philippe Minodier

    Recruiting

  • Hopital de Meaux

    Meaux

    Olivier Vignaud

    Fleury Marjory

    Recruiting

  • Ch de Melun

    Meulin

    Caroline Thach

    Recruiting

  • CH de Montargis

    Montargis

    Richard Gruss

    Recruiting

  • CH de MONTBRISON

    Montbrison

    Christine Roche

    Recruiting

  • Hopital Arnaud de Villeneuve

    Montpellier

    Lea Thevenet

    Recruiting

  • CHRU de Nancy

    Nancy

    Florent Girard

    Cyril Schweitzer

    Recruiting

  • Nantes - Hopital Mere Enfant

    Nantes

    Anne Drouard

    Recruiting

  • Ch de Neuilly Sur Seine

    Neuilly-sur-Seine

    Mariana Marin

    Recruiting

  • Hopital Lenval

    Nice

    hervé Haas

    Recruiting

  • CHU Nimes Caremeau

    Nîmes

    Sophie Odorico, MD

    Recruiting

  • Chr Orleans

    Orléans

    Françoise Monceaux

    Imen Jhaouat

    Recruiting

  • Assistance Publique Hôpitaux de Paris

    Paris, 75004

    François Angoulvant

    François Angoulvant

    Recruiting

  • Hopital St Jean Roussillon

    Perpignan

    Paulin Meslin

    Recruiting

  • POISSY - CH de POISSY

    Poissy

    Philippe Blanc

    Recruiting

  • QUIMPER - CH de Cornouaille

    Quimper

    Camille Loeile

    Recruiting

  • RANG du FLIERS - C.H.A.M.

    Rang-du-Fliers

    Sylvie Louf

    Recruiting

  • Hopital Américain CHU REIMS

    Reims

    Elmerich Florence

    Recruiting

  • CH RODEZ

    Rodez

    Bernard Caurier

    Recruiting

  • CH de ROMANS

    Romans-sur-Isère

    Patricia Guglielmino

    Recruiting

  • Chu Rouen

    Rouen

    Nathalie Mestre

    Recruiting

  • Hopital Charles-Nicolle

    Rouen

    Didier Pinquier

    Recruiting

  • Chu Felix Guyon

    Saint-Denis, La Réunion

    Benjamin Azemar

    Recruiting

  • Ch de Saint Denis

    Saint-Denis

    Alexis Mandelcwajg, MD

    Recruiting

  • Chu St Etienne

    Saint-Etienne

    Aymeric Cantais

    Recruiting

  • Ch Du Pays Du Mont Blanc

    Sallanches

    Emmanuelle Dessioux

    Recruiting

  • Chg Salon de Provence

    Salon-de-Provence

    Eric Moulène

    Recruiting

  • Ch de Saint Malo

    St-Malo

    Jean-Marie Lepage

    Recruiting

  • CH Hautepierre

    Strasbourg

    Jeanne Bordet

    Yvan De Feraudy

    Recruiting

  • CH Tarbes

    Tarbes

    Vanessa Latry, MD

    Recruiting

  • CH Bel Air

    Thionville

    Jean-Marc Schneider

    Recruiting

  • Hopital Sainte Musse

    Toulon

    Paul Casha

    Recruiting

  • CHU Toulouse-hôpital des Enfants

    Toulouse

    camille Brehin

    Recruiting

  • Hôpital Gatien De Clocheville

    Tours

    Zoha Maakaroun-Vermesse

    Charlotte Idier

    Recruiting

  • Hôpital Nord Franche-Comté

    Trévenans

    Nicoleta Ursulescu

    Recruiting

  • CH de TROYES

    Troyes

    Brigitte zimmerman

    Stéphane Sanchez

    Recruiting

  • Ch Bretagne Atlantique

    Vannes

    Cécilia Marques, MD

    Recruiting

  • Ch Le Chesnay

    Versailles

    Marie-Aliette Dommergue

    Véronique Hentgen

    Recruiting

  • Hopital de Villeneuve Saint Georges

    Villeneuve-Saint-Georges

    Aurélie Garraffo, MD

    Recruiting

Other trials in France

About this study

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 ).

Read more

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.

Conditions
COVID-19
Being tested
hospitalized children with Covid19
Keywords
children, pediatric department
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hospitalized children with Covid19Other

    All patients under 18 years hospitalized with a covid19 diagnosis

Study groups in NCT04336956
Study groupRoleWhat they receive
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
Receives: Other: hospitalized children with Covid19

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of children with severe or critical form.

    Measured: Day 14

Secondary outcomes (13)

  1. Percentage of children requiring intensive care support

    Measured: at admission

  2. Percentage of children requiring intensive care support

    Measured: at day 14

  3. Clinical symptoms of children

    requiring intensive care support or not

    Measured: at admission

  4. Clinical symptoms of children

    requiring intensive care support or not

    Measured: day 14

  5. Biological results of children

    requiring intensive care support or not

    Measured: at admission

  6. Biological results of children

    requiring intensive care support or not

    Measured: day 14

  7. CT chest of children

    requiring intensive care support or not

    Measured: at admission

  8. Pulmonary echography

    requiring intensive care support or not

    Measured: Day 14

  9. nasopharynx SARScov2 PCR

    Measured: at admission

  10. nasopharynx sarscov2 load

    if available

    Measured: at day 7

  11. nasopharynx multiplex PCR

    if available

    Measured: at admission

  12. number of hospital days

    days

    Measured: up to 12months

  13. Evaluation of long covid

    Measured: up to 12months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2020
  2. Study start7 Apr 2020
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion30 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
5,000 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04336956
Sponsor's protocol ID
PANDOR
Acronym
PANDOR
Status last verified
Nov 2022
First submitted
30 Mar 2020
Last updated
25 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39961110

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19, run by Centre Hospitalier Intercommunal Creteil at 76 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Corinne Levy, MD (148850404 ext. 0033, corinne.levy@activ-france.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of children with severe or critical form. (time frame: Day 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04336956, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2022.

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