Human genetics of myocarditis: overall, after mRNA COVID-19 vaccination, and after SARS-CoV-2 infection

Study identification

• EU PAS number:
  EUPAS1000000728
• Study ID:
  1000000728
• Official title and acronym:
  Human genetics of myocarditis: overall, after mRNA COVID-19 vaccination, and after SARS-CoV-2 infection
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is a non-interventional, retrospective case-control genetic association study using secondary data from the US-based Helix Research Network (HRN) Myocarditis Registry, where patients with myocarditis (cases) and patients without myocarditis (controls) will be identified. ; Cases and controls will be individuals who previously consented to participate in genetic research studies and for whom clinical information is available. ; The study will include the below three cohorts of cases. ; • Cohort A – post-mRNA COVID-19 vaccination myocarditis cases: myocarditis within 14 days of mRNA vaccination ; • Cohort B – post-SARS-CoV-2 infection myocarditis cases: myocarditis within 8 weeks of SARS-CoV-2 infection; • Cohort C – acute/viral myocarditis cases: myocarditis unrelated to COVID-19 vaccination or SARS-CoV-2 infection; Controls will be individuals without myocarditis who previously consented to participate in the HRN. ;
• Study status:
  Ongoing

Research institutions and networks

Institutions

Pfizer

Helix, Inc.

Study timelines

Date when funding contract was signed

Planned:06/06/2023

Actual:06/06/2023

Study start date

Planned:19/01/2026

Actual:20/01/2026

Date of final study report

Planned:15/08/2026

Sources of funding

Pharmaceutical company and other private sector 

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

C4591078