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

Myocarditis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06189053
• Other study ID #: mRNA-1273-P911
• Status: Active, not recruiting
• Start date: April 30, 2022
• Est. completion date: October 31, 2028

Study information

• Verified date: October 2023
• Source: ModernaTX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: October 31, 2028
• Est. primary completion date: October 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Myocarditis

Locations

Country	Name	City	State
United States	Veradigm	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Major Adverse Clinical Outcomes	Adverse clinical outcomes may include myocardial infarction, heart failure, stroke, and cardiovascular hospitalization.	Up to 5 years
Primary	Number of Participants with Persistent Cardiac Abnormality		Up to 5 years
Primary	Functional Assessment: Number of Participants Reporting Symptoms of Chest Pain, Dyspnea, Palpitations, and Syncope		Up to 5 years
Primary	Functional Assessment: Number of Participants Returning to Normal Activities		Up to 5 years