Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 1111 for:    COVID-19 | Child

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04420468
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : May 24, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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
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.

Layout table for study information
Study Type : Observational
Estimated 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 : June 10, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Acute myocarditis [ Time Frame: 7 days ]
    Occurrence, description and time course of acute myocarditis

  2. Multi-systemic inflammatory syndrome [ Time Frame: 7 days ]
    Occurrence, description and time course of multi-systemic inflammatory syndrome, features of Kawasaki disease

  3. Kawasaki disease [ Time Frame: 7 days ]
    Occurrence, description and time course of features of Kawasaki disease


Secondary Outcome Measures :
  1. Results of SARS-CoV-2 [ Time Frame: 7 days ]
    Results of SARS-CoV-2 screening either by PCR or antibodies serological assay



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04420468


Contacts
Layout table for location contacts
Contact: Marion Grimaud, MD 1 87 89 20 19 ext +33 marion.grimaud@aphp.fr
Contact: Hélène Morel 1 71 19 63 46 ext +33 helene.morel@aphp.fr

Locations
Layout table for location information
France
Hôpital Bicêtre Recruiting
Le Kremlin-Bicêtre, France, 94270
Contact: Clémence Marais, MD       clemence.marais@aphp.fr   
Hôpital Armand Trousseau Recruiting
Paris, France, 75012
Contact: Julie Starck, MD       julie.starck@aphp.fr   
Hôpital Necker-Enfants Malades Recruiting
Paris, France, 75015
Contact: Marion Grimaud, MD    1 87 89 20 19 ext +33    marion.grimaud@aphp.fr   
Hôpital Robert Debré Recruiting
Paris, France, 75019
Contact: Michäel Levy, MD       michael.levy@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Principal Investigator: Marion Grimaud Assistance Publique - Hôpitaux de Paris
Study Director: Sylvain Renolleau, MD, PhD Assistance Publique - Hôpitaux de Paris
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04420468    
Other Study ID Numbers: APHP200632
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: May 24, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
COVID-19
Acute myocarditis
Children
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Myocarditis
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases