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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-30

Study Completion Date

2028-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Myocarditis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cohort 1: Post-vaccine Myocarditis (PVM)

Cohort 1 will include participants with a myocarditis event diagnosis or service date within 30 days on/after a SPIKEVAX vaccination and participants with at least 1 dose of SPIKEVAX in the 7 days prior to and including the index date.

No interventions assigned to this group

Cohort 2: All Other Myocarditis

Cohort 2 will include participants with no evidence of SPIKEVAX and no evidence of other vaccines targeting SARS CoV-2 within 30 days on/after a SPIKEVAX vaccination.

No interventions assigned to this group

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No