Status:
ACTIVE_NOT_RECRUITING
A Study to Assess Long-term Outcomes of Myocarditis Following Administration of COVID-19 mRNA Vaccine (SPIKEVAX)
Lead Sponsor:
ModernaTX, Inc.
Conditions:
Myocarditis
Eligibility:
All Genders
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...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
April 30 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2028
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT06189053
Start Date
April 30 2022
End Date
October 31 2028
Last Update
August 1 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Veradigm
Chicago, Illinois, United States, 60654