NCT06113692

A Study on the Clinical Course, Outcomes and Risk Factors of Myocarditis and Pericarditis After Moderna COVID-19 Vaccine

Clinical Course, Outcomes and Risk Factors of Myocarditis and Pericarditis Following Administration of mRNA- 1273 (ELASOMERAN)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,169 (actual)
• Sponsor: ModernaTX, Inc. · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

Summary

The main goal of this study is to describe the clinical course, outcomes and risk factors for myocarditis and pericarditis associated with Moderna vaccination targeting SARS-CoV-2.

Detailed description

This study will use an "Moderna vaccination targeting SARS-CoV-2 - exposed case cohort design" to assess the risk factors other than Moderna vaccination targeting SARS-CoV-2 vaccination for the development of myocarditis and pericarditis in Moderna vaccination targeting SARS-CoV-2 recipients, to understand which characteristics increase or decrease the risk for the development of myocarditis and pericarditis after Moderna vaccination targeting SARS-CoV-2 vaccination. The second design "a myocarditis/pericarditis cohort study design" will be used to describe the prognostic factors for a severe clinical course in participants with myocarditis or pericarditis regardless of vaccination status. As most myocarditis and pericarditis cases are mild in disease severity, it is clinically relevant to identify the participants who are at increased risk for severe clinical outcomes (such as acute coronary syndrome, acute myocardial infarction, heart failure, atrial fibrillation/flutter, ventricular arrhythmias/cardiac arrest, pulmonary embolism or deep venous thrombosis, stroke outcomes, peripheral arterial embolism, hospital readmission, intensive care unit \[ICU\] admission or death) as early as possible in order to provide appropriate care in a timely manner. Therefore, information available at the onset of myocarditis or pericarditis could be used to predict the clinical course including long-term outcomes.

Conditions

• Myocarditis, Pericarditis

Interventions

Type	Name	Description
BIOLOGICAL	mRNA-1273	intramuscular injection

Timeline

• Start date: 2023-03-31
• Primary completion: 2024-08-31
• Completion: 2025-06-30
• First posted: 2023-11-02
• Last updated: 2025-08-01

Locations

5 sites across 4 countries: Denmark, Norway, Spain, United Kingdom