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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Recruiting

CT.gov ID

NCT04420468

Collaborator

(none)

Enrollment

Locations

13.7

Anticipated Duration (Months)

7.5

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jun 10, 2020

Anticipated Primary Completion Date :

Aug 1, 2021

Anticipated Study Completion Date :

Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Results of SARS-CoV-2 [7 days]
Results of SARS-CoV-2 screening either by PCR or antibodies serological assay

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 17 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hôpital Bicêtre	Le Kremlin-Bicêtre	France	94270
2	Hôpital Armand Trousseau	Paris	France	75012
3	Hôpital Necker-Enfants Malades	Paris	France	75015
4	Hôpital Robert Debré	Paris	France	75019

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator: Marion Grimaud, Assistance Publique - Hôpitaux de Paris
Study Director: Sylvain Renolleau, MD, PhD, Assistance Publique - Hôpitaux de Paris