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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Myocarditis COVID-19 Cardiomyopathies Cardiovascular Diseases Coronaviridae Infections Coronavirus Infections Heart Diseases Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Veradigm

Chicago, Illinois, 60654, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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.
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

Sponsors and collaborators

Lead sponsor

ModernaTX, Inc.

Industry

Registry information

Official study title

Long-term Outcomes of Myocarditis Following Administration of SPIKEVAX (COVID-19 Vaccine mRNA)

Important dates

Study start: 2022
Primary completion: 2027
Study completion: 2028
First posted: Jan 3, 2024
Registry last updated: Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed