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

Active, not recruiting

• Conditions: Myocarditis

• Registration Number: NCT06189053
• Lead Sponsor: ModernaTX, Inc.

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.

Study Timeline

• Study Start: 2022-04-30
• Study First Submitted: 2024-01-01
• Study First Submitted QC: 2024-01-01
• Study First Posted: 2024-01-03
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-14
• Primary Completion: 2027-10-31
• Study Completion: 2028-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional Assessment: Number of Participants Returning to Normal Activities	Up to 5 years
Number of Participants with Persistent Cardiac Abnormality	Up to 5 years
Number of Participants with Major Adverse Clinical Outcomes	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	Up to 5 years

Trial Locations

Locations (1)

Veradigm; 🇺🇸 Chicago, Illinois, United States