Active — Not RecruitingNot Applicable

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

United States1,500 participantsStarted 2022-04-30

Plain-language 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.

Who can participate

SexALL

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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.

What they're measuring

Number of Participants with Major Adverse Clinical Outcomes

Timeframe: Up to 5 years

Number of Participants with Persistent Cardiac Abnormality

Timeframe: Up to 5 years

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

Timeframe: Up to 5 years

Functional Assessment: Number of Participants Returning to Normal Activities

Timeframe: Up to 5 years

Trial details

NCT IDNCT06189053

SponsorModernaTX, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-10-31

View on ClinicalTrials.gov More Myocarditis trials