Long-term Outcomes of Myocarditis Following Administration of SPIKEVAX (COVID-19 Vaccine mRNA)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myocarditis
- Sponsor
- ModernaTX, Inc.
- Enrollment
- 1500
- Locations
- 1
- Primary Endpoint
- Functional Assessment: Number of Participants Returning to Normal Activities
- Status
- Active, not recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
The main goal of this study is to characterize presentation, clinical course, and long-term outcomes of myocarditis temporally associated with administration of mRNA-1273 (SPIKEVAX) COVID-19 vaccine.
Detailed Description
This is an observational cohort study that combines data collected directly from healthcare providers (HCP) with existing retrospective real-world data as captured in clinical electronic health record (EHR) and administrative claims data. Vaccine exposure and case identification information will be obtained retrospectively from existing real-world data to identify cases of post-vaccine myocarditis (PVM) and ultimately vaccine-associated myocarditis (VAM) for potential study inclusion. Eligible participants will be identified and followed for up to 5 years until the end of the study period or loss to follow-up or death.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants with a diagnosis of myocarditis between December 18, 2020, and October 31, 2026, will be identified or who have a relevant combination of laboratory and clinical findings meeting the CDC case definition for probable or confirmed myocarditis will be included in the study.
- •Participants will be required to have at least 30 days of medical history to assess SPIKEVAX exposure.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Functional Assessment: Number of Participants Returning to Normal Activities
Time Frame: Up to 5 years
Number of Participants with Persistent Cardiac Abnormality
Time Frame: Up to 5 years
Number of Participants with Major Adverse Clinical Outcomes
Time Frame: Up to 5 years
Adverse clinical outcomes may include myocardial infarction, heart failure, stroke, and cardiovascular hospitalization.
Functional Assessment: Number of Participants Reporting Symptoms of Chest Pain, Dyspnea, Palpitations, and Syncope
Time Frame: Up to 5 years