A Study to Assess Long-term Outcomes of Myocarditis Following Administration of COVID-19 mRNA Vaccine (SPIKEVAX)

N/AActive Not RecruitingNCT06189053

ModernaTX, Inc.1,500 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,500

Conditions

Myocarditis

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Veradigm

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Number of Participants with Major Adverse Clinical Outcomes

Adverse clinical outcomes may include myocardial infarction, heart failure, stroke, and cardiovascular hospitalization.

Time frame: Up to 5 years

Number of Participants with Persistent Cardiac Abnormality

Time frame: Up to 5 years

Functional Assessment: Number of Participants Reporting Symptoms of Chest Pain, Dyspnea, Palpitations, and Syncope

Time frame: Up to 5 years

Functional Assessment: Number of Participants Returning to Normal Activities

Time frame: Up to 5 years

Data from ClinicalTrials.gov

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