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Completed

NCT Number: NCT04420468

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Bicêtre, Le Kremlin-Bicêtre, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Acute myocarditis

    Time frame: 7 days

    Occurrence, description and time course of acute myocarditis

  2. Multi-systemic inflammatory syndrome

    Time frame: 7 days

    Occurrence, description and time course of multi-systemic inflammatory syndrome, features of Kawasaki disease

  3. Kawasaki disease

    Time frame: 7 days

    Occurrence, description and time course of features of Kawasaki disease

Secondary outcomes

  1. Results of SARS-CoV-2

    Time frame: 7 days

    Results of SARS-CoV-2 screening either by PCR or antibodies serological assay

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: HEART-COVID

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 9, 2020
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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