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

COVID-19 Clinical Trial

— HEART-COVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04420468
• Other study ID #: APHP200632
• Status: Completed
• Start date: June 10, 2020
• Est. completion date: May 31, 2022

Study information

• Verified date: March 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Myocarditis

Locations

Country	Name	City	State
France	Hôpital Bicêtre	Le Kremlin-Bicêtre
France	Hôpital Armand Trousseau	Paris
France	Hôpital Necker-Enfants Malades	Paris
France	Hôpital Robert Debré	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (2)

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 foll — View Citation

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 childre — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute myocarditis	Occurrence, description and time course of acute myocarditis	7 days
Primary	Multi-systemic inflammatory syndrome	Occurrence, description and time course of multi-systemic inflammatory syndrome, features of Kawasaki disease	7 days
Primary	Kawasaki disease	Occurrence, description and time course of features of Kawasaki disease	7 days
Secondary	Results of SARS-CoV-2	Results of SARS-CoV-2 screening either by PCR or antibodies serological assay	7 days