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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04420468

Acronym

HEART-COVID

Enrollment

Registered

2020-06-09

Start date

2020-06-10

Completion date

2022-05-31

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

COVID-19, Acute myocarditis, Children

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 17 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Acute myocarditis	7 days	Occurrence, description and time course of acute myocarditis
Multi-systemic inflammatory syndrome	7 days	Occurrence, description and time course of multi-systemic inflammatory syndrome, features of Kawasaki disease
Kawasaki disease	7 days	Occurrence, description and time course of features of Kawasaki disease

Secondary

Measure	Time frame	Description
Results of SARS-CoV-2	7 days	Results of SARS-CoV-2 screening either by PCR or antibodies serological assay

Countries

France

Outcome results