COVID-19HEART-COVIDNCT04420468
Descriptive and Retrospective Analysis of Acute Myocarditis Associated With Pandemic COVID-19 in Children
An observational study of COVID-19, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- COVID-19
- How many people
- 20 participants
- Where
- 4 sitesFrance
- Study dates
- 10 Jun 2020to 31 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- Age < 18 years
- Admitted to PICU from April 2020
- Presented with an acute myocarditis, fever and shock with a possible COVID-19 infection
Who cannot join
- Age ≥ 18 years
- Other etiologies of acute myocarditis than the COVID-19
- Opposition expressed by the holders of parental authority
Trial locations and contacts
4 sites in 1 country.
France4 sites
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
Hôpital Armand Trousseau
Paris, 75012
Hôpital Necker-Enfants Malades
Paris, 75015
Hôpital Robert Debré
Paris, 75019
About this study
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.
Read the 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.
- Conditions
- COVID-19
- Keywords
- COVID-19, Acute myocarditis, Children
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Acute myocarditis
Occurrence, description and time course of acute myocarditis
Measured: 7 days
Multi-systemic inflammatory syndrome
Occurrence, description and time course of multi-systemic inflammatory syndrome, features of Kawasaki disease
Measured: 7 days
Kawasaki disease
Occurrence, description and time course of features of Kawasaki disease
Measured: 7 days
Secondary outcomes (1)
Results of SARS-CoV-2
Results of SARS-CoV-2 screening either by PCR or antibodies serological assay
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start10 Jun 2020
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Marion Grimaud, Principal investigator, Assistance Publique - Hôpitaux de ParisSylvain Renolleau, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420468
- Sponsor's protocol ID
- APHP200632
- Acronym
- HEART-COVID
- Status last verified
- Sep 2025
- First submitted
- 5 Jun 2020
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35501302Grimaud 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.
PubMed 32488505Borgel 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.
PubMed 34049308
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive and Retrospective Analysis of Acute Myocarditis Associated With Pandemic COVID-19 in Children
- ClinicalTrials.gov ID
- NCT04420468
- Acronym / sponsor ID
- HEART-COVID / APHP200632
- Conditions
- COVID-19
- Keywords
- COVID-19, Acute myocarditis, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (3 listed)
- Age < 18 years
- Admitted to PICU from April 2020
- Presented with an acute myocarditis, fever and shock with a possible COVID-19 infection
Key exclusion criteria (3 listed)
- Age ≥ 18 years
- Other etiologies of acute myocarditis than the COVID-19
- Opposition expressed by the holders of parental authority
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acute myocarditis
Time frame: 7 days
Occurrence, description and time course of acute myocarditis
Multi-systemic inflammatory syndrome
Time frame: 7 days
Occurrence, description and time course of multi-systemic inflammatory syndrome, features of Kawasaki disease
Kawasaki disease
Time frame: 7 days
Occurrence, description and time course of features of Kawasaki disease
1 secondary outcome
Results of SARS-CoV-2
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Results publication: PubMed 35501302McCafferty 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.
- Results publication: PubMed 32488505Grimaud 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.
- Derived from this study: PubMed 34049308Borgel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marion Grimaud principal investigator
Assistance Publique - Hôpitaux de Paris
Sylvain Renolleau, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute myocarditis (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04420468, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.