Myocarditis AcutePhase 2CORIUMNCT06896253
Pulse Corticosteroids Or/and Immunoglobulins to Treat Fulminant Myocarditis
A Phase 2 study testing Pulse bolus corticosteroids, Pulse bolus corticosteroids and IVIG and Pulse bolus corticosteroids (G5%) and IVIG (G5 %) in people with Myocarditis Acute, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Fulminant myocarditis (FM) is the most severe manifestation of acute myocarditis, an acute inflammatory myocardial disease most often triggered by viral infections. Currently, the most accepted definition of FM requires acute illness, hemodynamic compromise due to cardiogenic shock, and need for hemodynamic support… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Myocarditis Acute
- What is being tested?
- Pulse bolus corticosteroids, Pulse bolus corticosteroids and IVIG and Pulse bolus corticosteroids (G5%) and IVIG (G5 %)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Apr 2025to Nov 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. Fulminant myocarditis defined by
- the acute illness (<1 month from symptom onset),
- hemodynamic compromise due to cardiogenic shock (confirmed by echocardiography) or electrical storm,
- elevated plasma cardiac troponin > twice normal value
- need for hemodynamic support (inotropes or temporary mechanical circulatory support) for less than 72 hours in the absence of an ischemic cause or other pre-existing cardiomyopathies Noticeably, a coronary angiogram should be performed in patients ≥40 years of age when myocarditis has not been proven histologically. Besides, an endomyocardial biopsy will not be mandatory to fulfill the definition of fulminant myocarditis.
- 2. Signed informed consent from the patient, a close relative or surrogate or a family member or a legal representative for minor patient.
- Adult : According to the specifications of emergency inclusion, randomization without the close relative/surrogate consent could be performed if the patientis unable to give his/her consent and when the close relative/surrogate/family member are absent. Close relative/surrogate/family member consent will be asked as soon as possible after randomization. The patient will be asked as soon as possible to give his/her consent for the continuation of the trial when his/her condition will allow.
- Minor : According to the specifications of emergency inclusion, randomization could be performed when legal representative are absent. Legal representative consent will be asked as soon as possible after randomization 3. Social security registration (AME excluded)
Who cannot join
- 1. Age <15 2. Pregnancy or breastfeeding or baby delivery <6 months 3. Initiation of inotropes or temporary mechanical circulatory support >72 hours 4. Resuscitation >20 minutes (cumulative low-flow time > 20 minutes ) 5. Pre-existing ischemic or dilated cardiomyopathy or Tako-Tsubo evaluated by echocardiography.
- 6. Known systemic autoimmune disorder or other conditions requiring immunosuppression 7. Patients with peripheral eosinophilia (≥1000 G/L) 8. Myocarditis associated with anti-cancer immune checkpoint inhibitor agents 9. Active severe bacterial or fungal infectious disease 10. Patient moribund on the day of randomization, SAPS II >90 11. Contraindication or allergies to corticosteroids or immunoglobulins or any components of the formulations or their excipients 12. Patients already on corticosteroids or receiving IVIG 13. Participation in another interventional study or being in the exclusion period at the end of a previous study.
- 14. Patients with an uncontrolled psychotic condition Patients with known anti-IgA antibodies in line with the contraindications of methylprednisolone IV and of IVIg based products respectively
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pulse Corticosteroids Or/and Immunoglobulins to Treat Fulminant Myocarditis: a Double-blind Randomized Controlled Adaptive Trial the CORIUM Study
Fulminant myocarditis (FM) is the most severe manifestation of acute myocarditis, an acute inflammatory myocardial disease most often triggered by viral infections.
Currently, the most accepted definition of FM requires acute illness, hemodynamic compromise due to cardiogenic shock, and need for hemodynamic support (inotropes and/or temporary mechanical circulatory support (t-MCS) in the absence of an ischemic cause or other pre-existing cardiomyopathies. Unfortunately, there is a paucity of evidence-based management strategies for this disease and the management of patients affected by FM often varies according to local experience and practice with the role of immunosuppression being the most debated issue.
Besides, due to inconsistent results obtained in several studies and frequent spontaneous recovery with supportive therapy alone, immunosuppression is largely debated in the setting of lymphocytic myocarditis (LM). Among available medications for this disease, corticosteroids are often used despite a lack of clear evidence in the context of FM. Similarly, intravenous immunoglobulin (IVIG) has both antiviral and anti-inflammatory effects on myocarditis. In adults, a recent meta-analysis based on case series showed that IVIG therapy significantly reduced in-hospital mortality, improved the left ventricular ejection fraction, and significantly increased the survival rate in patients with FM. More recently, FM among patients with COVID-19, including post-infectious multisystem inflammatory syndrome, has been reported in young adult patients. These severe forms have been successfully treated with intravenous corticosteroids and IVIG, highlighting the relevance of the systemic inflammatory response in determining cardiac injury in COVID-19, even though more evidence is needed.
- Conditions
- Myocarditis Acute
- Being tested
- Pulse bolus corticosteroids, Pulse bolus corticosteroids and IVIG, Pulse bolus corticosteroids (G5%) and IVIG (G5 %)
- Keywords
- Fulminant myocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse bolus corticosteroidsDrug
Treatment administration
Pulse bolus corticosteroids and IVIGDrug
Treatment administration
Pulse bolus corticosteroids (G5%) and IVIG (G5 %)Drug
Treatment administration
| Study group | Role | What they receive |
|---|---|---|
| Pulse bolus corticosteroids group | Experimental | 1. 1 gram/day of methylprednisolone IV for three days followed by 1mg/kg/day IV until inotropes weaning or 7 days whatever come first.
2. Placebo of IVIG: glucose 5% 0.5g/kg/day for 4 days Receives: Drug: Pulse bolus corticosteroids |
| Pulse bolus corticosteroids and IVIG group | Experimental | 1. 1 gram/day of methylprednisolone IV for three days followed by 1mg/kg/day IV until inotropes weaning or 7 days whatever come first.
2. 0.5g/kg/day IVIG for 4 days. Receives: Drug: Pulse bolus corticosteroids and IVIG |
| Double placebo pulse bolus corticosteroids (G5%) and IVIG (G5 %) | Placebo comparator | Not described Receives: Drug: Pulse bolus corticosteroids (G5%) and IVIG (G5 %) |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite hierarchical outcome composed of four components : 1) mortality at D28 2) heart transplant/VAD/persisting t-MCS at D28, and 3) number of days alive without t-MCS and inotropes at D28
Each patient will be compared with every other patient in the study and assigned a score (tie: 0, win: +1, loss: -1) for each pairwise comparison based on whom fared better. If one patient survived without heart transplantation or long-term assist ventricular device or t-MCS still ongoing at day 28 and the other does not, scores of +1 and -1 will be assigned, respectively. Otherwise, the assigned score will depend on which patient had more days free from t-MCS and inotropes: the patient with more days off t-MCS and inotropes will receive a score of +1, and the other patient -1. If both patients survived and had the same number of days off t-MCS and inotropes, or if both patients died or had a heart transplant or a VAD, they will be both assigned a score of 0 for that pairwise comparison. For each patient, scores for all pairwise comparisons will be summed, resulting in a cumulative score which will be the primary endpoint of the study.
Measured: Day 28
Secondary outcomes (13)
Mortality
Measured: Day 28, Day 60, Day 90
Number of temporary mechanical circulatory support free days
Measured: Day 28
Number of inotropes-free days
Measured: Day 28
Incidence of ventricular assisted device use
Measured: Day 28, Day 60, Day 90
Incidence of heart transplant
Measured: Day 28, Day 60, Day 90
Left ventricular function (%) assessed by echocardiography (Simpson method)
Measured: Day 3, Day 7, Day 14, Day 28
Time to normalize troponin
Measured: From randomization to Day 14
Time to normalize N-terminal pro-B-type natriuretic peptide
Measured: From randomization to Day 14
Incidence of drugs side effects
nosocomial infections, significant gastrointestinal bleeding, renal insufficiency, acute delirium leading to the use of neuroleptic agents
Measured: From randomization to Day 28
Proportion of patients with left ventricular ejection fraction < 55%
Measured: Day 28, 6 months
Proportion of patients with left ventricular dilatation
Measured: Day 28, 6 months
Proportion of patients with late gadolinium enhancement evaluated by cardiac magnetic resonance imaging
Measured: 6 months
Incidence of hyperglycemia
Measured: From randomization to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study startApr 2025 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocarditis AcuteStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alain COMBES, MD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896253
- Sponsor's protocol ID
- APHP220808
- Other IDs
- 2023-506599-28-01, 2023
- Acronym
- CORIUM
- Status last verified
- Feb 2025
- First submitted
- 12 Feb 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulse Corticosteroids Or/and Immunoglobulins to Treat Fulminant Myocarditis: a Double-blind Randomized Controlled Adaptive Trial the CORIUM Study
- ClinicalTrials.gov ID
- NCT06896253
- Acronym / sponsor ID
- CORIUM / APHP220808
- Conditions
- Myocarditis Acute
- Keywords
- Fulminant myocarditis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 26 Mar 2025 (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.
Fulminant myocarditis (FM) is the most severe manifestation of acute myocarditis, an acute inflammatory myocardial disease most often triggered by viral infections.
Currently, the most accepted definition of FM requires acute illness, hemodynamic compromise due to cardiogenic shock, and need for hemodynamic support (inotropes and/or temporary mechanical circulatory support (t-MCS) in the absence of an ischemic cause or other pre-existing cardiomyopathies. Unfortunately, there is a paucity of evidence-based management strategies for this disease and the management of patients affected by FM often varies according to local experience and practice with the role of immunosuppression being the most debated issue.
Besides, due to inconsistent results obtained in several studies and frequent spontaneous recovery with supportive therapy alone, immunosuppression is largely debated in the setting of lymphocytic myocarditis (LM). Among available medications for this disease, corticosteroids are often used despite a lack of clear evidence in the context of FM. Similarly, intravenous immunoglobulin (IVIG) has both antiviral and anti-inflammatory effects on myocarditis. In adults, a recent meta-analysis based on case series showed that IVIG therapy significantly reduced in-hospital mortality, improved the left ventricular ejection fraction, and significantly increased the survival rate in patients with FM. More recently, FM among patients with COVID-19, including post-infectious multisystem inflammatory syndrome, has been reported in young adult patients. These severe forms have been successfully treated with intravenous corticosteroids and IVIG, highlighting the relevance of the systemic inflammatory response in determining cardiac injury in COVID-19, even though more evidence is needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pulse bolus corticosteroids group | Experimental | Drug: Pulse bolus corticosteroids1. 1 gram/day of methylprednisolone IV for three days followed by 1mg/kg/day IV until inotropes weaning or 7 days whatever come first. 2. Placebo of IVIG: glucose 5% 0.5g/kg/day for 4 days |
| Pulse bolus corticosteroids and IVIG group | Experimental | Drug: Pulse bolus corticosteroids and IVIG1. 1 gram/day of methylprednisolone IV for three days followed by 1mg/kg/day IV until inotropes weaning or 7 days whatever come first. 2. 0.5g/kg/day IVIG for 4 days. |
| Double placebo pulse bolus corticosteroids (G5%) and IVIG (G5 %) | Placebo comparator | Drug: Pulse bolus corticosteroids (G5%) and IVIG (G5 %) |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Fulminant myocarditis defined by
- 2. Signed informed consent from the patient, a close relative or surrogate or a family member or a legal representative for minor patient.
Key exclusion criteria (3 listed)
- 1. Age <15 2. Pregnancy or breastfeeding or baby delivery <6 months 3. Initiation of inotropes or temporary mechanical circulatory support >72 hours 4. Resuscitation >20 minutes (cumulative low-flow time > 20 minutes ) 5. Pre-existing ischemic or dilated cardiomyopathy or Tako-Tsubo evaluated by echocardiography.
- 6. Known systemic autoimmune disorder or other conditions requiring immunosuppression 7. Patients with peripheral eosinophilia (≥1000 G/L) 8. Myocarditis associated with anti-cancer immune checkpoint inhibitor agents 9. Active severe bacterial or fungal infectious disease 10. Patient moribund on the day of randomization, SAPS II >90 11. Contraindication or allergies to corticosteroids or immunoglobulins or any components of the formulations or their excipients 12. Patients already on corticosteroids or receiving IVIG 13. Participation in another interventional study or being in the exclusion period at the end of a previous study.
- 14. Patients with an uncontrolled psychotic condition Patients with known anti-IgA antibodies in line with the contraindications of methylprednisolone IV and of IVIg based products respectively
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulse bolus corticosteroidsTreatment administration | Drug | Pulse bolus corticosteroids group |
| Pulse bolus corticosteroids and IVIGTreatment administration | Drug | Pulse bolus corticosteroids and IVIG group |
| Pulse bolus corticosteroids (G5%) and IVIG (G5 %)Treatment administration | Drug | Double placebo pulse bolus corticosteroids (G5%) and IVIG (G5 %) |
Primary outcome
A composite hierarchical outcome composed of four components : 1) mortality at D28 2) heart transplant/VAD/persisting t-MCS at D28, and 3) number of days alive without t-MCS and inotropes at D28
Time frame: Day 28
Each patient will be compared with every other patient in the study and assigned a score (tie: 0, win: +1, loss: -1) for each pairwise comparison based on whom fared better. If one patient survived without heart transplantation or long-term assist ventricular device or t-MCS still ongoing at day 28 and the other does not, scores of +1 and -1 will be assigned, respectively. Otherwise, the assigned score will depend on which patient had more days free from t-MCS and inotropes: the patient with more days off t-MCS and inotropes will receive a score of +1, and the other patient -1. If both patients survived and had the same number of days off t-MCS and inotropes, or if both patients died or had a heart transplant or a VAD, they will be both assigned a score of 0 for that pairwise comparison. For each patient, scores for all pairwise comparisons will be summed, resulting in a cumulative score which will be the primary endpoint of the study.
13 secondary outcomes
Mortality
Time frame: Day 28, Day 60, Day 90
Number of temporary mechanical circulatory support free days
Time frame: Day 28
Number of inotropes-free days
Time frame: Day 28
Incidence of ventricular assisted device use
Time frame: Day 28, Day 60, Day 90
Incidence of heart transplant
Time frame: Day 28, Day 60, Day 90
Left ventricular function (%) assessed by echocardiography (Simpson method)
Time frame: Day 3, Day 7, Day 14, Day 28
Time to normalize troponin
Time frame: From randomization to Day 14
Time to normalize N-terminal pro-B-type natriuretic peptide
Time frame: From randomization to Day 14
Incidence of drugs side effects
Time frame: From randomization to Day 28
Proportion of patients with left ventricular ejection fraction < 55%
Time frame: Day 28, 6 months
Proportion of patients with left ventricular dilatation
Time frame: Day 28, 6 months
Proportion of patients with late gadolinium enhancement evaluated by cardiac magnetic resonance imaging
Time frame: 6 months
Incidence of hyperglycemia
Time frame: From randomization to Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: Yes. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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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.
Alain COMBES, MD study director
Assistance Publique - Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pulse bolus corticosteroids, Pulse bolus corticosteroids and IVIG and Pulse bolus corticosteroids (G5%) and IVIG (G5 %) in people with Myocarditis Acute, run by Assistance Publique - Hôpitaux de Paris.
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 8 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: opening soon, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthieu SCHMIDT, MD (33142162937, matthieu.schmidt@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite hierarchical outcome composed of four components : 1) mortality at D28 2) heart transplant/VAD/persisting t-MCS at D28, and 3) number of days alive without t-MCS and inotropes at D28 (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2025.