Descriptive and Retrospective Analysis of Acute Myocarditis Associated With Pandemic COVID-19 in Children

NCT ID: NCT04420468

Last Updated: 2025-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-10

Study Completion Date

2022-05-31

Brief Summary

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The study objectives are to descript clinical, biological and echocardiographic features of an acute myocarditis in children in the context of COVID-19 and to identify the underlying mechanism : direct viral damage and/or inadequate host response risk.

Detailed Description

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An unexpected increase of shock with fever in children suspected to be infect by the COVID-19 is observed. These children present with similar symptoms and seem to have similar clinical time course.

This unexpected phenomenon needs to be extensively described in order to further the knowledge of unusual COVID-19 presentation in children.

The study consists an extensive retrospective data collection from April 2020 till the end of the main SARS-Cov-2 outbreak, from medical file of children have exhibited acute myocarditis and cared in 4 pediatric intensive care units of Assistance Publique-Hôpitaux de Paris of Ile-de-France region.

The study objectives are to descript clinical, biological and echocardiographic features of an acute myocarditis in children in the context of COVID-19 and to identify the underlying mechanism : direct viral damage and/or inadequate host response risk.

Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Possible COVID-19 infection and acute myocarditis

Children presented with an acute myocarditis, fever and shock with a possible COVID-19 infection cared between April 2020 till the end of the main SARS-Cov-2 outbreak in 4 AP-HP Parisian hospitals :

* Necker-Enfants Malades
* Armand Trousseau
* Robert Debré
* Kremlin Bicêtre

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age \< 18 years
* Admitted to PICU from April 2020
* Presented with an acute myocarditis, fever and shock with a possible COVID-19 infection

Exclusion Criteria

* Age ≥ 18 years
* Other etiologies of acute myocarditis than the COVID-19
* Opposition expressed by the holders of parental authority
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marion Grimaud

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Sylvain Renolleau, MD, PhD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hôpital Bicêtre

Le Kremlin-Bicêtre, , France

Site Status

Hôpital Armand Trousseau

Paris, , France

Site Status

Hôpital Necker-Enfants Malades

Paris, , France

Site Status

Hôpital Robert Debré

Paris, , France

Site Status

Countries

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France

References

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McCafferty C, Cai T, Borgel D, Lasne D, Renolleau S, Vedrenne-Cloquet M, Bonnet D, Wu J, Zaw T, Bhatnagar A, Song X, Van Den Helm S, Letunica N, Attard C, Karlaftis V, Praporski S, Ignjatovic V, Monagle P. Pathophysiological pathway differences in children who present with COVID-19 ARDS compared to COVID -19 induced MIS-C. Nat Commun. 2022 May 2;13(1):2391. doi: 10.1038/s41467-022-29951-9.

Reference Type BACKGROUND
PMID: 35501302 (View on PubMed)

Grimaud M, Starck J, Levy M, Marais C, Chareyre J, Khraiche D, Leruez-Ville M, Quartier P, Leger PL, Geslain G, Semaan N, Moulin F, Bendavid M, Jean S, Poncelet G, Renolleau S, Oualha M. Acute myocarditis and multisystem inflammatory emerging disease following SARS-CoV-2 infection in critically ill children. Ann Intensive Care. 2020 Jun 1;10(1):69. doi: 10.1186/s13613-020-00690-8.

Reference Type BACKGROUND
PMID: 32488505 (View on PubMed)

Borgel D, Chocron R, Grimaud M, Philippe A, Chareyre J, Brakta C, Lasne D, Bonnet D, Toubiana J, Angoulvant F, Desvages M, Renolleau S, Smadja DM, Oualha M. Endothelial Dysfunction as a Component of Severe Acute Respiratory Syndrome Coronavirus 2-Related Multisystem Inflammatory Syndrome in Children With Shock. Crit Care Med. 2021 Nov 1;49(11):e1151-e1156. doi: 10.1097/CCM.0000000000005093.

Reference Type DERIVED
PMID: 34049308 (View on PubMed)

Other Identifiers

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APHP200632

Identifier Type: -

Identifier Source: org_study_id

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