NCT04420468

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

June 10, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

2 years

First QC Date

June 5, 2020

Last Update Submit

September 8, 2025

Conditions

COVID-19

Keywords

COVID-19Acute myocarditisChildren

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Results of SARS-CoV-2

    7 days

Study Arms (1)

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

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

Hôpital Armand Trousseau

Paris, 75012, France

Location

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

Hôpital Robert Debré

Paris, 75019, France

Location

Related Publications (3)

  • 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.

    PMID: 35501302BACKGROUND

  • 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.

    PMID: 32488505BACKGROUND

  • 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.

    PMID: 34049308DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Marion Grimaud

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

  • Sylvain Renolleau, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2020

First Posted

June 9, 2020

Study Start

June 10, 2020

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

September 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)