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

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.

Study Overview

• Status: Completed
• Conditions: 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.

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

• Study Contact: Name: Marion Grimaud, MD; Phone Number: +33 1 87 89 20 19; Email: marion.grimaud@aphp.fr

Study Locations

• France
  • Le Kremlin-Bicêtre, France, 94270
    • Hôpital Bicêtre
  • Paris, France, 75019
    • Hôpital Robert Debré
  • Paris, France, 75012
    • Hôpital Armand Trousseau
  • Paris, France, 75015
    • Hôpital Necker-Enfants Malades

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Director: Sylvain RENOLLEAU, MD, PhD, Assistance Publique - Hôpitaux de Paris; Principal Investigator: Marion Grimaud, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• Published online 2020, PMID: 32488505

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2020
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: June 5, 2020
• First Submitted That Met QC Criteria: June 5, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Children; COVID-19; Acute myocarditis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Cardiomyopathies; COVID-19; Myocarditis
• Other Study ID Numbers: APHP200632

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No